"J Drugs Dermatol"[jour];
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J Drugs Dermatol
. 2020 Sep 1;19(9):889-892. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5323.
Systemic Medications of Dermatological Importance in COVID-19
Robert A Schwartz, Aseem Sharma, Jacek C Szepietowski, Sunmeet Sandhu, Mohamad Goldust
PMID: 33026746
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5323
Abstract
Early December 2019 witnessed an international outbreak of a novel coronavirus (COVID 19) designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2). Since then, a number of therapeutic molecules have been explored to have potential efficacy against the SARS-Cov-2 per se or its sequelae. There are no Food and Drug Administration specific therapies approved so far; however, numerous drugs based on varying levels of evidence, in vitro studies and compassionate drug trials are being established as therapeutic agents, especially drugs approved for previous emergence of the severe acute respiratory syndrome (SARS-CoV-1) and Middle east respiratory syndrome coronavirus (MERS-Cov). Numerous active clinical trials for COVID-19 with more than 150 drugs and products are under study. Needless to say, many dermatological drugs are being employed to mitigate this pandemic threat. We aim to review drugs with potential against SARS-Cov-2 widely used in dermatology practice. Additionally, rampant and overzealous use of these drugs as well as introduction of new molecules might lead to emergence of adverse effects associated with these agents. Dermatologists must be on lookout for any cutaneous adverse effects of these drugs. J Drugs Dermatol. 2020;19(9):889-892. doi:10.36849/JDD.2020.5323.
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J Drugs Dermatol
. 2020 Oct 1;19(10):960-967. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5590.
Outcome Disparities Among Men and Women With COVID-19: An Analysis of the New York City Population Cohort
Nahid Punjani, Albert Ha, Joseph Caputo, Vinson Wang, Lisa Wiechmann, Mary Ann Chiasson, Philip Li, James Hotaling, Thomas Walsh, Joseph Alukal
PMID: 33026775
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5590
Abstract
Background: Growing evidence suggests a possible sex disparity in COVID-19 disease related outcomes.
Objective: To explore the sex disparity in COVID-19 cases and outcomes using New York City (NYC) population level data.
Setting: NYC surveillance data from February 29 to June 12, 2020.
Participants: Individuals tested for COVID-19 in metropolitan NYC.Outcome Measurements and Statistical Analysis: Outcomes of interest included rates of COVID-19 case positivity, hospitalization and death. Relative risks and case fatality rates were computed for all outcomes based on sex and were stratified by age groups.
Results and limitations: 911,310 individuals were included, of whom 434,273 (47.65%) were male and 477,037 (52.35%) were female. Men represented the majority of positive cases (n=106,275, 51.36%), a majority of hospitalizations (n=29,847, 56.44%), and a majority of deaths (n=13,054, 59.23%). Following population level adjustments for age and sex, testing rates of men and women were equivalent. The majority of positive cases and hospitalizations occurred in men for all age groups except age >75 years, and death was more likely in men of all age groups. Men were at a statistically significant greater relative risk of case positivity, hospitalization, and death across all age groups except those <18 years of age. The most significant difference for case positivity was observed in the 65–74 age group (RR 1.22, 95%CI 1.19–1.24), for hospitalization in the 45–65 age group (RR 1.85, 95% 1.80–1.90), and for death in the 18–44 age group (RR 3.30, 95% CI 2.82–3.87). Case fatality rates were greater for men in all age-matched comparisons to women. Limitations include the use of an evolving surveillance data set and absence of further demographic characteristics such as ethnographic data.
Conclusion: Men have higher rates of COVID-19 positivity, hospitalization, and death despite greater testing of women; this trend remains after stratification by age. J Drugs Dermatol. 2020;19(10):960-967. doi:10.36849/JDD.2020.5590.
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J Drugs Dermatol
. 2020 Oct 1;19(10):929-934. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5367.
Rationale for Use of Combination Therapy in Rosacea
Linda Stein Gold, Hilary Baldwin, Julie C Harper
PMID: 33026776
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5367
Abstract
Background: Rosacea is a chronic skin condition characterized by primary and secondary manifestations affecting the centrofacial skin. The primary diagnostic phenotypes for rosacea are fixed centrofacial erythema with periodic intensification, and phymatous changes. Major phenotypes, including papules and pustules, flushing, telangiectasia, and ocular manifestations, may occur concomitantly or independently with the diagnostic features. The phenotypes of rosacea patients may evolve between subtypes and may require multiple treatments concurrently to be effectively managed. We report the proceedings of a roundtable discussion among 3 dermatologists experienced in the treatment of rosacea and present examples of rosacea treatment strategies that target multiple rosacea symptoms presenting in individual patients.
Methods: Three hypothetical cases describing patients representative of those commonly seen by practicing dermatologists were developed. A roundtable discussion was held to discuss overall and specific strategies for treating rosacea based on the cases.
Results/discussion: With few exceptions, the dermatologists recommended combination therapy targeting each manifestation of rosacea for each case. These recommendations are in agreement with the current American Acne and Rosacea Society treatment guidelines for rosacea and are supported by several studies demonstrating beneficial results from combining rosacea treatments.
Conclusions: Rosacea is an evolving condition; care should take into account all clinical signs and symptoms of rosacea that are present in an individual patient, understanding that symptoms may change over time, and utilize combination therapy when applicable to target all rosacea symptoms. J Drugs Dermatol. 2020;19(10): 929-934. doi:10.36849/JDD.2020.5367.
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J Drugs Dermatol
. 2020 Sep 1;19(9):836-842. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5374.
Safety and Effectiveness of Hyaluronic Acid Fillers With Lidocaine for Full-Face Treatment in Asian Patients
She-Hung Huang, Tsen-Fang Tsai
PMID: 33026748
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5374
Abstract
Background: There is a need for further evaluation of hyaluronic acid fillers for aesthetic use in Asia, where treatment goals may differ from western countries.
Objective: To evaluate 24-month safety and effectiveness of two hyaluronic acid fillers with lidocaine when used for full-face aesthetic treatment in Asian patients.
Methods: This was a 24-month, evaluator-blinded, non-comparative, multi-center study. Female subjects were injected with 3-5 mL Restylane® Lidocaine and/or Restylane Lyft Lidocaine, manufactured using the NASHA™ technology, in 2–4 pre-defined areas; upper cheeks, nasolabial folds, temples, nose, and chin. A second treatment was performed after 12 months. Assessments included aesthetic improvement, subject satisfaction, assessment scales for upper cheeks and nasolabial folds, and safety (adverse events and subject diaries).
Results: One hundred subjects were included; total mean volumes were 4.7 mL and 3.1 mL at first and second treatment, respectively. At least 82% of subjects were rated as aesthetically improved over 24 months by subjects themselves and by investigators. Most subjects (73-90%) were satisfied with the treatment throughout the study. Upper cheek improvement 12 months after treatment was significantly higher after second treatment (≥69% of subjects) than after first treatment (≥38%), P<0.0001, Fisher’s exact test. A total of 29 treatment related adverse events were reported by 16% of subjects, all were mild (79%) or moderate (21%) in intensity. Most commonly reported were pain and bruising. Tenderness was the most common diary record in all treatment areas.
Conclusion: Full-face treatments with the study products resulted in long-term aesthetic improvement, perceived by both subjects and investigators. Subject satisfaction was high and maintained over 24 months with one re-treatment. Repeated treatment of several facial indications showed a satisfactory safety profile. J Drugs Dermatol. 2020;19(9):836-842. doi:10.36849/JDD.2020.5374.
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J Drugs Dermatol
. 2020 Sep 1;19(9):852-856. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5048.
Human Pharmacokinetics and Safety of Subcutaneous Collagenase Clostridium Histolyticum in Women
Ashish C Bhatia, Michael P McLane, Tony Priestley, Saji Vljyan, Martin K Gelbard
PMID: 33026751
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5048
Abstract
Background: Clostridium collagenase histolyticum (CCH) is being evaluated in women as a cellulite treatment.
Objective: To report preclinical safety and human pharmacokinetics (PK) and safety data for CCH.
Methods: Across 3 PK studies, 41 women received 12 subcutaneous injections per thigh/buttock in 1 session (up to 3.36 mg/dose). Blood samples were taken at baseline; at 5, 10, 20, and 30 minutes postdose; and at 1, 2, 4, 8, 12, 24, 48, 168, and 504 hours postdose. In a preclinical study, rats received 0, 0.029, 0.13, or 0.29 mg/dose of CCH intravenously (IV) every other day (QOD) for 16 days (total, 8 doses) and were evaluated for histopathologic changes.
Results: In human PK studies, no quantifiable plasma concentrations of AUX-I or AUX-II were observed postdose (n= 39 evaluable). Adverse events were injection site–related (bruising [97.6%], pain [87.8%], and edema/swelling [46.3%]). Antidrug antibodies were seen in most women at 504 hours postdose. In rats, plasma concentrations of AUX-I and AUX-II (CCH components) were measurable for 30 minutes and 1-2 hours, respectively, after IV administration. At ≥43× proposed human therapeutic dose on a mg/kg basis, rats experienced elevated liver enzyme levels, increased liver weights, and histologic changes that were mostly reversed during a 14-day recovery period.
Conclusions: In human studies, no quantifiable circulating CCH levels were observed after a single subcutaneous dose of CCH up to 3.36 mg. Preclinical data indicated that repeat IV dosing (QOD; 8 doses) at ≥43× proposed human dose on a mg/kg basis for CCH was generally well tolerated.J Drugs Dermatol. 2020;19(9):852-856. doi:10.36849/JDD.2020.5048THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.
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6
J Drugs Dermatol
. 2020 Oct 1;19(10):935-940. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5393.
Atopic Dermatitis and the Role of the Skin Microbiome in Choosing Prevention, Treatment, and Maintenance Options
Hilary Baldwin, Crystal Aguh, Anneke Andriessen, Latanya Benjamin, Aaron S Ferberg, Deirdre Hooper, Joseph L Jarizzo, Peter A Lio, Brook Tlougan, Heather C Woolery-Lloyd, Joshua Zeichner
PMID: 33026777
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5393
Abstract
Background: Atopic dermatitis (AD) is a common skin condition characterized by disturbed barrier function, skin inflammation, and cutaneous dysbiosis. Clinically, it manifests as chronic-recurrent xerosis, pruritus, and erythematous lesions. Its pathophysiology is complex, making the selection of appropriate treatment options a task.
Aim: To share insights gained from a literature review and discussions with experts in dermatology on key factors related to the prevention, treatment, and management of AD in relation to the skin microbiome.
Methods: Results from an expert panel were summarized and discussed to provide updated recommendations for the treatment and maintenance of AD.
Results: Evidence supports a strategy for managing inflammatory skin diseases with a selenium-rich post-biotic thermal water and biomass containing moisturizer. The moisturizer helps to restore homeostasis of the skin, re-populate a diverse microbiome, encourage the growth of commensal bacteria, and improve barrier function and symptoms of AD.
Conclusions: Normalization of skin microbiome diversity using a topical moisturizer containing post-biotic aqua and biomass may offer a valuable option for the treatment and maintenance of inflammatory skin diseases. Clinicians should discuss the benefits of this treatment in the context of a full AD management program that covers prevention, active treatment, and maintenance. J Drugs Dermatol. 2020;19(10):935-940. doi:10.36849/JDD.2020.5393.
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J Drugs Dermatol
. 2020 Oct 1;19(10):993-998. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5416.
Hyaluronidase in Dermatology: Uses Beyond Hyaluronic Acid Fillers
Tamara Searle, Faisal R Ali, Firas Al-Niaimi
PMID: 33026763
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5416
Abstract
Hyaluronidase is mostly widely recognized for its off-label use in correction of complications of hyaluronic acid fillers. However, its utility in other aspects of dermatology is less widely acknowledged. We describe the varied uses of hyaluronidase in dermatology and the underlying evidence base for its dermatological indications. This includes its uses in enhancing drug delivery (for local anesthesia, keloid and hypertrophic scars, and for Kaposi’s sarcoma), in the treatment of disorders associated with mucin deposition (myxedema, scleroderma, scleredema, and cutis verticis gyrata) and its potential uses in surgery (as a pre-operative adjuvant in dermatofibrosarcoma protuberans, for periorbital edema, and for hematomas). In select circumstances, hyaluronidase might be more efficacious than more established treatments with fewer adverse effects. We propose hyaluronidase as the latest addition to our global dermatological armamentarium and implore dermatologists to consider its use to enhance their practice.J Drugs Dermatol. 2020;19(10):993-998. doi:10.36849/JDD.2020.5416.
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8
J Drugs Dermatol
. 2020 Oct 1;19(10):978-983. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5269.
Prospective Analysis in Patients With HAE Under Prophylaxis With Lanadelumab: A Real-life Experience
Janina Hahn, Susanne Trainotti, Marlene C Wigand, Patrick J Schuler, Thomas K Hoffmann, Jens Greve
PMID: 33026762
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5269
Abstract
Background and objectives: Patients with the rare disease hereditary angioedema (HAE) suffer from recurrent acute attacks of edema. There is no curative therapy, but the frequency of attacks and quality of life of severely affected patients can be improved by prophylactic therapy. The monoclonal antibody lanadelumab has been approved for routine prophylaxis in patients with HAE since November 2018.
Patients and methods: In this prospective assessment, a long-term therapy with lanadelumab was initiated in 12 adult patients with HAE. We analyzed their course of disease 6 months after the start of long-term prophylactic therapy using a validated quality-of-life questionnaire and evaluated the frequency and severity of attacks as well as side effects. Furthermore, the therapy with lanadelumab was compared with the previous medication.
Results: To date, our study is the first prospective quality of life analysis in HAE patients under treatment with lanadelumab in real life conditions. Mean attack frequencies were reduced from 6.4 to 0.3 attacks per month and patient in our cohort (P<0.0001). No severe attacks occurred under lanadelumab prophylaxis. In all patients, quality of life increased significantly.
Conclusions: Lanadelumab is an effective but expensive long-term prophylaxis for HAE patients. A favorable side-effect profile has been shown. J Drugs Dermatol. 2020;19(10):978-983. doi:10.36849/JDD.2020.5269.
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9
J Drugs Dermatol
. 2020 Sep 1;19(9):883-888. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5106.
Reconstruction of Cutaneous Defects of the Ear Using the Post-Auricular Reservoir: A Systematic Review
Brandon Worley, Joel L Cohen
PMID: 33026744
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5106
Abstract
Background: An approach to the reconstruction of the ear requires consideration of gross anatomy, blood supply, and size of the defect to select the repair. While skin grafts provide a convenient option for many helical and conchal defects, using posterior auricular reservoir can preserve ear contour and hide the scar for an aesthetic closure.
Purpose: To illustrate the versatility of the post-auricular and mastoid skin reservoir for auricular repairs after surgical removal of a cutaneous malignancy.
Data sources: MEDLINE, EMBASE, and Cochrane Databases were searched for all techniques using a post-auricular approach for auricular repair of surgical defects in the context of cutaneous oncology until November 2019.
Data synthesis: The most well-described techniques of pull-through, post-auricular pedicle and Banner flaps were selected for in-depth review. Illustrative cases and a summary of the spectrum of techniques from case reports are provided.
Limitations: Few randomized trials exist to compare the outcomes of the flaps to determine a preferred flap technique.
Conclusions: A post-auricular approach for repair of auricular defects can provide a reasonable option for single and multi-staged closure to create an excellent aesthetic outcome while hiding the donor site. More prospective data is required to determine the overall best approach. J Drugs Dermatol. 2020;19(9):883-888. doi:10.36849/JDD.2020.5106.
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J Drugs Dermatol
. 2020 Aug 1;19(8):788-792. doi: 10.36849/JDD.2020.5079.
The Therapeutic Use of Antioxidants for Melasma
Kayla M Babbush, Remy A Babbush, Amor Khachemoune
PMID: 32845595
DOI: 10.36849/JDD.2020.5079
Abstract
Melasma is a chronic dermatologic condition with an incompletely understood pathogenesis and well-demonstrated impact on patient quality of life. Melasma is a common cause for seeking dermatologic care, and with no universally efficacious therapy or cure, com-bination treatment is the best approach for many cases. Numerous studies have demonstrated the role of oxidative stress in patients with melasma, prompting investigation into several antioxidants for melasma therapy. In this review, we discuss the well-defined role of oxidative stress in melasma and the therapeutic efficacy of various antioxidants for patients suffering from melasma. We focus our discussion on studies investigating the role of vitamin C, azelaic acid, cysteamine, glutathione, carotenoids, and numerous other antioxidants in disorders of hyperpigmentation. There is promising evidence for the use of these antioxidants, as topical, oral, and intra-venous preparations, both in isolation and in conjunction with other melasma therapies. J Drugs Dermatol. 2020;19(8):788-792. doi:10.36849/JDD.2020.5079.
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11
J Drugs Dermatol
. 2020 Oct 1;19(10):956-959. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5214.
Topical Agents Currently in Phase II or Phase III Trials for Atopic Dermatitis
Shelley K Uppal, Vipawee S Chat, Donovan G Kearns, Jashin J Wu
PMID: 33026767
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5214
Abstract
Mild to moderate atopic dermatitis (AD) occurs frequently in children and adults and is usually managed through the use of pharmacologic treatments, such as topical corticosteroids (TCS) and topical calcineurin inhibitors (TCIs), and good skin care practices. As chronic TCS or TCI can lead to the development of adverse effects, there is a need for safe, alternative treatments for patients with resistant AD. A systemic literature review was performed to examine the safety and efficacy of topical agents currently in phase II and phase III clinical trials for AD. Our team searched the databases, PubMed, Google Scholar, and ClinicalTrials.gov, on March 2020 for studies pertaining to the use of topical agents in AD. Key words included each drug (tapinarof, crisaborole, ARQ-151 cream, ruxolitinib) or “topical agents” combined with “atopic dermatitis.” Articles published within the last 5 years were included as references. References within retrieved articles were also reviewed to identify potentially missed studies. A total of 24 articles were included in this review. Tapinarof, crisaborole, and ruxolitinib lead to statistically significant improvements in multiple disease severity scores. ARQ-151 cream achieved statistical significance in secondary endpoints, including vIGA-AD and EASI-75, but not in the primary endpoint of the study. All topical agents were well-tolerated by study participants. The findings demonstrate that tapinarof, crisaborole, ARQ-151 cream, and ruxolitinib are safe, effective treatment options for patients with mild to moderate AD. J Drugs Dermatol. 2020;19(10):956-959. doi:10.36849/JDD.2020.5214.
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12
J Drugs Dermatol
. 2020 Oct 1;19(10):969-976. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5054.
Hydrogen Peroxide Topical Solution, 45% for Common Warts: Phase 2 Efficacy and Safety Trial Results
Stacy R Smith, Stephen K Trying, Kimberly K Grande, Joel Schlessinger, Michael H Gold, Stuart D Shanier
PMID: 33026766
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5054
Abstract
Background: No FDA-approved prescription therapies are available for common warts.
Objective: We evaluated a proprietary hydrogen peroxide topical solution, 45% (w/w) (HP45) for treatment of common warts.
Methods: In the phase 2 randomized, double-blind, vehicle-controlled WART-203 trial (NCT03278028), eligible patients aged ≥8 years had 1–6 warts (1 target wart) on the trunk or extremities with a Physician’s Wart Assessment™ (PWA) grade ≥2 (range, 0 [clear] to 3 [wart 3–8 mm in diameter or length]). Patients self-administered HP45 or vehicle twice weekly for 8 weeks and were evaluated through 12 weeks posttreatment (week 20). Efficacy assessments included mean change in target wart PWA grade from baseline at week 8 (primary endpoint) and proportions of patients with target wart clearance. Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs).
Results: A total of 157 patients completed 8 weeks of treatment (HP45, n=79; vehicle, n=78); 151 patients completed the 20-week posttreatment evaluation (HP45, n=75; vehicle, n=76). A significantly greater reduction in mean target wart PWA grade from baseline at week 8 was achieved with HP45 (−0.87) vs vehicle (−0.17; P<0.0001) and maintained at week 20 (−1.00 vs −0.39; P=0.0004). The proportion of patients with target wart clearance at week 8 was significantly greater with HP45 (25.3%) vs vehicle (2.6%; P<0.0001) and remained significantly greater at week 20 (37.3% vs 11.8%; P=0.0002). Forty-seven patients reported 76 TEAEs; most were mild or moderate in severity. Most LSRs were mild and resolved by week 20. In pediatric patients (HP45, n=13; vehicle, n=6), greater reductions in mean target wart PWA grade from baseline were observed with HP45 vs vehicle at weeks 8 (−1.0 vs 0) and 20 (−1.2 vs −0.5).
Conclusion: These findings support the efficacy and safety of HP45 for the treatment of common warts in patients ≥8 years of age. J Drugs Dermatol. 2020;19(10):969-976. doi:10.36849/JDD.2020.5054.
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J Drugs Dermatol
. 2020 Aug 1;19(8):769-776. doi: 10.36849/JDD.2020.5252.
A Consensus About the Importance of Ceramide Containing Skincare for Normal and Sensitive Skin Conditions in Neonates and Infants
Lawrence A Schachner, Anneke Andriessen, Latanya Benjamin, Alanna F Bree, Peter A Lechman, Ayleen A Pinera-Llano, Leon Kircik
PMID: 32845590
DOI: 10.36849/JDD.2020.5252
Abstract
Background: Neonates and infants are susceptible to skin barrier disruption as their skin anatomically and functionally is still developing. The process of skin acidification plays a vital role in barrier maturation and the activation of enzymes involved in the extracellular processing of stratum corneum lipids. The current consensus paper explores challenges, and current treatment approaches in neonatal and infant normal and sensitive skin and the role of ceramides containing moisturizers. Methods: For this purpose, an expert panel of pediatric dermatologists and dermatologists discussed information from systematic literature searches, coupled with expert opinion and experience of the panel, to adopt eight statements. The consensus process consisted of a modified Delphi technique. Results: During the first years after birth, the neonatal and infant skin is more permeable to topical agents and, therefore, requires particular caution with topical skincare regimens. Mildly acidic or pH-neutral cleansers have benefits for neonates and infants. Skincare for neonates and infants should be safe, effective, and fragrance free as well as sensitizing agent-free. Additionally, the skincare should be pleasant to use, containing ingredients that benefit the lipid and water content of the SC, such as those products containing ceramides. Conclusion: Taking into consideration the maturation process of neonatal and infant skin, the application of moisturizers and cleansers containing barrier lipids may help maintain the protective skin barrier and soothe with long-term moisturizing benefits. J Drugs Dermatol. 2020;19(8) 769-776: doi:10.36849/JDD.2020.5252 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.
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14
J Drugs Dermatol
. 2020 Oct 1;19(10):985-991. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5454.
IncobotulinumtoxinA Demonstrates Safety and Prolonged Duration of Effect in a Dose-Ranging Study for Glabellar Lines
Martina Kerscher, Sabrina Fabi, Tanja Fischer, Michael Gold, John Joseph, Welf Prager, Berthold Rzany, Steve Yoelin, Susanna Roll, Gudrun Klein, Corey Maas
PMID: 33026771
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5454
Abstract
Background: Recently reported clinical data provides evidence that increasing the dose of botulinum toxin A increases the duration of efficacy. A 2-stage Phase 2, randomized, double-blind study investigated the duration of effect and safety of IncobotulinumtoxinA (INCO; Xeomin®, Bocouture®; Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) at doses higher than the approved 20 units (U) for glabellar frown lines (GFL). Primary safety and efficacy endpoints of Stage 1 are reported here.
Methods: 151 subjects with moderate-to-severe GFL were randomized 1:2:2 to receive a single treatment with 20U, 50U, or 75U INCO. The primary efficacy endpoint was median duration of at least 1-point improvement from baseline as assessed by investigator at maximum frown on the Facial Wrinkle Scale.
Results: The median duration of effect was 185 days for the 50U dose group (95% CI:[182, 205]) and 210 days for the 75U dose group (95% CI:[182, 217]). Duration of effect was significantly longer for 75U vs 50U (P=0.0400) and 20U (P=0.0166) despite the study not being powered for confirmatory statistical significance testing between the dose groups. Duration of effect was also longer for 50U vs 20U, however; statistical significance was not reached (P=0.4349). The incidence of treatment-related adverse events was low across all doses (20U:2[6.7%], 50U:6[10.0%] and 75U:8[13.1%]).
Conclusions: These results demonstrate a dose effect of at least 6 months duration with higher doses in the majority of GFL subjects. All doses were well tolerated and safety was consistent with the known safety profile of 20U INCO for GFL. J Drugs Dermatol. 2020;19(10):985-991. doi:10.36849/JDD.2020.5454.
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15
J Drugs Dermatol
. 2020 Sep 1;19(9):897-899. doi: 10.36849/JDD.2020.10.36849/JDD.2020.4856.
Biological Effects of Hyaluronic Acid-Based Dermal Fillers and Laser Therapy on Human Skin Models
Laura Huth, Yvonne Marquardt, Ruth Heise, Katharina Fietkau, Jens Malte Baron, Sebastian Huth
PMID: 33026754
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.4856
Abstract
Injection of dermal fillers is one of the most frequently performed aesthetic procedures. The aim of the present study was to investigate the biological effects of different stabilized hyaluronan (HA) and poly-l-lactic acid fillers with and without subsequent additional fractional laser co-treatment on skin morphology and gene expression. Intradermal injection resulted in a significant enhancement of epidermal thickness detected by histological analysis. Combining HA fillers with ablative fractional CO2- or Er:YAG laser irradiation enhanced this effect. Gene expression profiling revealed an upregulation of modulators of tissue remodeling (eg TIMP3, SERPIN E1) and collagens (COL11A1). On the other hand, we detected a downregulation of differentiation markers (eg FLG, LOR, KRT1) and proinflammatory cytokines (eg IL-36, IL-1β). Interestingly, HA-based fillers revealed a specific upregulation pattern of chemokines such as CXCL5 andCCL20 suggesting a secondary effect of these fillers on the immune cells of the skin, especially monocytes and macrophages. Taken together, our data show enhancing effects of dermal fillers on epidermal thickness and prove the proliferating effects of these products on epidermal cells on the molecular level. Moreover, our findings reveal synergistic effects of fractional ablative laser treatment and HA dermal filler injection suggesting a combination of both treatments. J Drugs Dermatol. 2020;19(9):897-899. doi:10.36849/JDD.2020.4856.
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16
J Drugs Dermatol
. 2020 Aug 1;19(8):713-720. doi: 10.36849/JDD.2020.4874.
Oral Metformin for Treating Dermatological Diseases: A Systematic Review
Calvin T Sung, Tiffany Chao, Alfred Lee, Delila Pouldar Foulad, Franchesca Choi, Margit Juhasz, Allison Dobry, Natasha Atanaskova Mesinkovska
PMID: 32845585
DOI: 10.36849/JDD.2020.4874
Abstract
Introduction:Metformin is an antihyperglycemic medication most commonly used to treat Type II Diabetes Mellitus with promising off-label application for the treatment of hidradenitis suppurativa, psoriasis, acne, acanthosis nigricans, and hirsutism. Objective: To comprehensively assess evidence regarding the use of metformin for treating primary cutaneous disorders. Materials and Methods: A systematic literature search was conducted through PubMed, Cochrane, Web of Science, and CINAHL to identify the role of metformin in primary skin disease. Results: Sixty-four studies met inclusion criteria. Metformin demonstrates promising clinical response and favorable safety profile for treatment of HS, with most patients experiencing a decrease in frequency or severity of HS flares, and some experiencing full resolution of HS lesions. Patients with psoriasis treated with metformin experienced quantifiable clinical responses. Application of metformin on polycystic ovarian disease (PCOS) related acne, acanthosis nigricans, and hirsutism yielded mixed clinical results. No serious adverse effects were reported. Conclusion: Metformin is safe and efficacious and may be considered as an adjunctive therapy for the treatment of psoriasis and hidradenitis suppurativa in addition to first line therapies as well as PCOS related acne, acanthosis nigricans, and hirsutism. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.4874.
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17
J Drugs Dermatol
. 2020 Sep 1;19(9):867-872. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5401.
Safety, Pharmacokinetics, and Efficacy of Efinaconazole 10% Topical Solution for Onychomycosis Treatment in Pediatric Patients
Lawrence F Eichenfield, Boni Elewski, Jeffrey L Sugarman, Ted Rosen, Tracey C Vlahovic, Aditya K Gupta, Linda Stein Gold, Radhakrishnan Pillai, Eric Guenin
PMID: 33026753
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5401
Abstract
Background: Pediatric onychomycosis management is challenging as there are limited treatment options. The objective of this study was to evaluate efinaconazole 10% topical solution in children with onychomycosis.
Methods: This phase 4, multicenter, open-label study (NCT02812771) evaluated safety, pharmacokinetics (PK), and efficacy of efinaconazole 10% topical solution in pediatric participants (6-16 years). Efinaconazole was administered once daily for 48 weeks, with a 4-week posttreatment follow up. Participants had culture-positive, mild-to-severe distal lateral subungual onychomycosis affecting at least 20% of at least 1 great toenail. The PK subset included participants 12-16 years with moderate-to-severe onychomycosis affecting at least 50% of each great toenail and onychomycosis in at least 4 additional toenails.
Results: Of 62 enrolled participants, 60 were included in the safety population and 17 in the PK population. Efinaconazole 10% topical solution was well tolerated. The concentration-time profiles for efinaconazole and its major metabolite were relatively stable, with only minor fluctuations during the 24-hour dosing interval. Systemic exposure to efinaconazole was low. By week 52, 65.0% of participants achieved mycologic cure, with a 36.7% mycologic cure rate observed as early as week 12. A total of 40.0% of participants achieved complete cure, 50.0% achieved clinical efficacy, and 88.3% achieved fungal cure by week 52.
Conclusion: Efinaconazole was safe and efficacious in pediatric participants with mild-to-severe onychomycosis, with improved mycologic cure and complete cure rates compared with adults from two 52-week studies. J Drugs Dermatol. 2020;19(9):867-872. doi:10.36849/JDD.2020.5401.
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18
J Drugs Dermatol
. 2020 Aug 1;19(8):777-783. doi: 10.36849/JDD.2020.5249.
Once-Daily Polymeric Tazarotene 0.045% Lotion for Moderate-to-Severe Acne: Pooled Phase 3 Analysis by Sex
Leon H. Kircik, Linda Stein Gold, Kenneth Beer, Jerry Tan, Hilary Baldwin, Eric Guenin, Robert Kang, Johnson Varughese
PMID: 32845584
DOI: 10.36849/JDD.2020.5249
Abstract
Background: Two identical phase 3 randomized, double-blind, vehicle-controlled, 12-week studies (NCT03168321 and NCT03168334) demonstrated the efficacy and safety of tazarotene 0.045% lotion in participants with moderate-to-severe acne. Data from these studies were pooled and analyzed post hoc to evaluate outcomes by sex. Methods: Patients aged ≥9 years with moderate-to-severe acne (score 3 or 4 on the Evaluator's Global Severity Score [EGSS]) were randomized (1:1) to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Outcomes comprised inflammatory/noninflammatory lesion counts, treatment success (proportion of participants achieving ≥2-grade reduction from baseline in EGSS and score of 0 [“clear”] or 1 [“almost clear”]), and treatment-emergent adverse events (TEAEs). Results: A total of 1,064 females and 550 males were included in this analysis. For both sexes, least-squares mean percent changes from baseline to week 12 in lesion counts were significantly greater with tazarotene 0.045% lotion versus vehicle (inflammatory: females, -60.1% vs -52.1%; males, -53.6% vs -39.8%; noninflammatory: females, -57.6% vs -44.9%; males, -52.9% vs -36.5%; P<0.001, all). The percentage of participants achieving treatment success at week 12 was also significantly higher with tazarotene 0.045% lotion versus vehicle in females and males (P<0.001, both). Compared with tazarotene-treated males, tazarotene-treated females had significantly greater changes from baseline in inflammatory and noninflammatory lesions and a greater proportion achieved treatment success at week 12 (P<0.05, all). TEAE rates were similar between tazarotene- and vehicle-treated males; rates were higher for tazarotene-treated females than vehicle-treated females. Conclusions: Tazarotene 0.045% lotion was efficacious and well tolerated in the treatment of moderate-to-severe acne in female and male participants. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5249
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19
J Drugs Dermatol
. 2020 Sep 1;19(9):844-850. doi: 10.36849/JDD.2020.10.36849/JDD.2020.4834.
Efficacy and Safety of Intense Pulsed Light With a KTP/PDLlike Filter for the Treatment of Facial Telangiectasias
Jennifer D Peterson, Daniel P Friedmann, Kaitlyn Abdo, Zoya Cahana
PMID: 33026752
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.4834
Abstract
Background: An intense pulsed light (IPL) narrowband "KTP/PDL-like" filter (525–585 nm) may combine the tolerability of the IPL with the precision of KTP and PDL lasers. This study evaluated the impact of IPL with a KTP/PDL-like filter on telangiectasias.
Methods: This was a single-center, prospective study of 17 subjects with facial telangiectasias and skin types I–III. Three monthly treatments were performed using this specific filter, with follow-up visits at 1, 3, and 6 months. Telangiectasia improvement was assessed by the investigator and subjects using a 5-point scale. Facial photographs and safety assessments were obtained at each visit. Subject discomfort was evaluated using a visual analog scale (VAS) immediately posttreatment, and subject downtime was recorded at each subsequent visit.
Results: All facial telangiectasias significantly improved. At 1-month follow-up, >50% lesion clearance was noted in 97.1% of facial (n=36) and 85.7% of non-facial (n=7) lesions, with 73% of subjects satisfied or very satisfied. An increase in mean social downtime (0, 2.3, and 3 days) and VAS scores (3.5, 4.5, and 4.8) with treatments 1, 2, and 3, respectively, mirrored a stepwise increase in fluence with subsequent sessions.
Conclusions: The use of a novel IPL narrowband KTP/PDL-like filter can significantly improve facial and non-facial telangiectasias with minimal downtime. J Drugs Dermatol. 2020;19(9):844-850. doi:10.36849/JDD.2020.4834.
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20
J Drugs Dermatol
. 2020 Aug 1;19(8):741-746. doi: 10.36849/JDD.2020.5116.
Nail Psoriasis Does Not Affect Skin Response to Ixekizumab in Patients With Moderate-To-Severe Psoriasis
Phoebe Rich, Orin Goldblum, Damon Disch, Chen-Yen Lin, Joseph F Merola, Boni Elewski
PMID: 32845588
DOI: 10.36849/JDD.2020.5116
Abstract
Background: Presence of nail psoriasis in patients with plaque psoriasis may be an indicator of greater disease severity. Previously, patients with nail psoriasis have had delayed skin clearance after treatment compared to patients without nail psoriasis. Objective: This post-hoc analysis evaluated the efficacy of ixekizumab in clearance of plaque psoriasis in patients with and without nail psoriasis. Methods: Data were integrated from two phase 3 clinical trials (UNCOVER-2 and UNCOVER-3; N=2570) to assess skin response over 12 weeks of treatment with subcutaneous placebo, etanercept, or ixekizumab in patients with and without nail psoriasis. Nail response was assessed using Nail Psoriasis Severity Index (NAPSI) and skin response was assessed as the percentage of patients achieving 75%, 90%, or 100% improvement in Psoriasis Area and Severity Index (PASI 75, PASI 90, PASI 100) or a score of 0 or 1 on the static Physician Global Assessment (sPGA 0 or 0,1). Results: From baseline to week 12, progressive improvement in psoriasis occurred with ixekizumab and etanercept treatment; however, significantly more patients with nail psoriasis than without mild PASI 75 at weeks 8 and 12 and sPGA (0,1) at week 12 with ixekizumab. Significantly more patients with severe nail psoriasis than mild achieved PASI 75 at weeks 8 and 12 with ixekizumab. Conclusion: Patients with and without nail psoriasis responded well to ixekizumab. The presence of nail psoriasis did not negatively affect skin clearance in patients treated with ixekizumab. ClinicalTrials.gov: NCT01597245, NCT01646177 J Drugs Dermatol. 2020;19(8):741-746. doi:10.36849/JDD.2020.5116.
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21
J Drugs Dermatol
. 2020 Aug 1;19(8):703-708. doi: 10.36849/JDD.2020.5337.
The Effect of Tildrakizumab on Cardiometabolic Risk Factors in Psoriasis by Metabolic Syndrome Status: Post Hoc Analysis of Two Phase 3 Trials (ReSURFACE 1 and ReSURFACE 2)
M Alan Menter, Nehal N Mehta, Mark G Lebwohl, Alice B Gottlieb, Alan M Mendelsohn, Stephen J Rozzo, Craig Leonardi
PMID: 32845115
DOI: 10.36849/JDD.2020.5337
Abstract
Background: Metabolic syndrome (MetS) is the most prevalent comorbidity in psoriasis and increases the risk of cardiovascular disease, diabetes, and mortality. Assessment of impacts of biologic therapies on cardiometabolic risk factors are relatively limited. This study evaluated the effect of tildrakizumab on cardiometabolic risk factors in patients with moderate to severe plaque psoriasis and stratified by MetS status. Methods: In this post hoc analysis of reSURFACE 1/2, tildrakizumab 100 and 200 mg were continuously administered to patients with moderate to severe plaque psoriasis at weeks 0 and 4, and every 12 weeks thereafter. Mean and mean percent changes from baseline were assessed for fasting serum glucose, low/high-density lipoprotein-cholesterol, total cholesterol, triglyceride levels, body weight, and blood pressure at week 64/52 for reSURFACE 1 and 2, respectively, in patients with and without MetS. Results: A total of 369 patients in reSURFACE 1 and 2 received continuous tildrakizumab 100 mg and 330 received tildrakizumab 200 mg; 21.4% and 20.3% in reSURFACE 1 and 2, respectively, had MetS. At week 64/52, mean changes in cardiometabolic risk factors from baseline did not significantly differ regardless of MetS status. Numerically larger mean decreases in fasting glucose, triglycerides, and systolic blood pressure following tildrakizumab 100 mg and in systolic and diastolic blood pressure following tildrakizumab 200 mg were observed in patients with MetS relative to those without MetS. Conclusions: Changes in cardiometabolic disease risk factors following tildrakizumab treatment were limited. Risk factors were not increased in patients with MetS vs without MetS. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5337.
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J Drugs Dermatol
. 2020 Aug 1;19(8):734-740. doi: 10.36849/JDD.2020.5370.
Roflumilast Cream Improves Signs and Symptoms of Plaque Psoriasis: Results from a Phase 1/2a Randomized, Controlled Study
Kim A Papp, Melinda Gooderham, Michael Droege, Charlotte Merritt, David W Osborne, David R Berk, Archie W Thurston, Valerie H Smith, Howard Welgus
PMID: 32845114
DOI: 10.36849/JDD.2020.5370
Abstract
Background: Roflumilast cream (ARQ-151) is a highly potent, selective phosphodiesterase-4 inhibitor in development for once-daily topical treatment of chronic plaque psoriasis. Objectives: To assess the safety and efficacy of once-daily roflumilast cream 0.5% and 0.15% in patients with chronic plaque psoriasis. Methods: This phase 1/2a study enrolled a single-dose, open-label cohort (Cohort 1: 0.5% cream applied to 25 cm² psoriatic plaques), and a 28-day, double-blinded cohort (Cohort 2: 1:1:1 randomization to roflumilast cream 0.5%, 0.15%, or vehicle). Patients had chronic plaque psoriasis of >6 months' duration with ≤5% body surface area involvement. Outcomes included safety (adverse events) and efficacy (percentage change in the Target Plaque Severity Score [TPSS] × Target Plaque Area [TPA]) at week 4. Results: For Cohorts 1 (n=8) and 2 (n=89), adverse events (all mild/moderate; none severe or serious) were similar between active arms and vehicle. Treatment-related events were confined to the application site, without differences between drug and vehicle. No patient discontinued treatment due to adverse events. The primary efficacy endpoint was met for both roflumilast cream doses: TPSS×TPA improvement at week 4 was statistically significant for roflumilast 0.5% (P=0.0007) and 0.15% (P=0.0011) versus vehicle; significance was reached as early as 2 weeks. For both roflumilast cream doses, 66%-67% improvement from baseline was observed at week 4, without reaching a plateau, versus 38% improvement for vehicle. Conclusion: Roflumilast cream was safe and highly effective at doses of 0.5% and 0.15% and represents a potential novel once-daily topical therapy for the treatment of chronic plaque psoriasis. ClinicalTrials.gov NCT03392168. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5370.
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23
J Drugs Dermatol
. 2020 Oct 1;19(10):921-926. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5498.
Clinical Relevance of Skin Pain in Atopic Dermatitis
Sonja Ständer, Eric L Simpson, Emma Guttman-Yassky, Jacob P Thyssen, Kenji Kabashima, Susan G Ball, Maria Jose Rueda, Amy M DeLozier, Jonathan I Silverberg
PMID: 33026764
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5498
Abstract
Skin pain is increasingly recognized as an impactful symptom in atopic dermatitis (AD) because of its association with patient discomfort, disease burden, and reduced quality of life. Although the nature of skin pain in AD has not been systematically studied and is therefore not well understood, patients report soreness, discomfort, and tenderness that may reflect peripheral and central pain sensitization. The high prevalence of skin pain suggests that it is not adequately addressed by current therapies for AD and may be undertreated compared with other symptoms. This review discusses the clinical relevance of skin pain with respect to its experience, pathophysiology, relationship with itch, and treatment implications. Recent studies suggest that skin pain presents as a neuropathic symptom independent from itch and the “itch-scratch cycle”, and poses a unique burden to patients. Recognition of the significant consequences of skin pain and discomfort should reinforce the need to assess and treat this symptom in patients with moderate-to-severe AD. J Drugs Dermatol. 2020;19(10)921-926. doi:10.36849/JDD.2020.5498.
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24
J Drugs Dermatol
. 2020 Aug 1;19(8):698-701. doi: 10.36849/JDD.2020.5104R1.
Increased Trend of Cosmetic Procedures in Patients With Psoriasis Who Attain 75% or Greater Improvement
Michelle E Walters, Delphine J Lee, Paul S Yamauchi
PMID: 32845593
DOI: 10.36849/JDD.2020.5104R1
Abstract
Background: The relationship between the clearance of psoriasis and improved quality of life together with an increased uptake of cosmetic procedures has not been reported to date. Objective: A survey was conducted at a single dermatology center to determine if there was an increased trend in cosmetic procedures in patients with moderate to severe psoriasis who attained 75% or greater reduction of the body surface area (BSA) with biologic agents and oral systemic therapies, and if this was related to an improvement in quality of life following psoriasis clearance. Study Design: In this case series, 138 patients with a history of moderate to severe psoriasis who attained 75% or greater body surface area (BSA) reduction with biologic agents or oral systemic therapies and had undergone at least one cosmetic procedure in the past 2 years were surveyed. Patient characteristics were collected including age, sex, percent BSA at initiation of therapy, the class of biologic or oral systemic therapies, and the different types of cosmetic procedures. Patients were asked to answer a 5-question survey on quality of life improvement, satisfaction with treatment, and correlation with the cosmetic procedure they had undergone, Patients also completed the Dermatology Quality of Life Index (DLQI) questionnaire in the survey. Results: The majority of patients who had undergone a cosmetic procedure after achieving 75% BSA stated that their psoriasis had previously prevented them from undergoing a cosmetic procedure. Regardless of therapy, all patients felt their quality of life had improved as a result of their treatment, and 91% of patients stated this was the impetus to undergo a cosmetic procedure. The mean DLQI score prior to therapy was 14.3 and 71% of patients reported a DLQI score of 0/1 after their psoriasis improved. Conclusion: There was a correlation between improvement in quality of life in patients who had achieved at least a 75% reduction in BSA with either a biologic agent, oral agent, or both, and the uptake of cosmetic procedures. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5104R1.
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25
J Drugs Dermatol
. 2020 Aug 1;19(8):763-768. doi: 10.36849/JDD.2020.4887.
Post-Inflammatory Hyperpigmentation: A Review of Treatment Strategies
Adele Shenoy, Raman Madan
PMID: 32845587
DOI: 10.36849/JDD.2020.4887
Abstract
Post-inflammatory hyperpigmentation (PIH) is a reactive process resulting from increased melanin or abnormal distribution of melanin secondary to inflammatory skin conditions, dermatologic therapies, and external stimuli. Because PIH is a common condition that has a substantial effect on the quality of life, an understanding of its treatment modalities is essential. Though there are many therapeutic strategies for hyperpigmentary conditions such as melasma that are described in the literature, fewer studies focus on PIH. This article aims to provide a comprehensive literature review of therapies specifically used to treat PIH, such as topical combinations, chemical peels, and lasers. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.4887.
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26
J Drugs Dermatol
. 2020 Aug 1;19(8):747-754. doi: 10.36849/JDD.2020.5250.
Halobetasol Propionate Lotion 0.01% for Moderate-to-Severe Plaque Psoriasis: Pooled Analysis in Male and Female Participants
Fran E Cook-Bolden, Adelaide A Hebert, Scott T Guenthner, Robert Kang, Gina Martin, Abby Jacobson
PMID: 32845589
DOI: 10.36849/JDD.2020.5250
Abstract
Introduction: Psoriasis is a chronic, immune-mediated skin disease that is associated with sex-related differences. Two double-blind, vehicle-controlled, phase 3 studies evaluated halobetasol propionate (HP) 0.01% lotion for the treatment of moderate-to-severe localized plaque psoriasis; pooled post hoc analyses investigated efficacy and safety in male and female subgroups. Methods: Participants were randomized (2:1) to once-daily HP or vehicle lotion for 8-weeks of double-blind treatment, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in male (n=253) and female (n=177) subgroups included treatment success (≥2‑grade improvement in Investigator's Global Assessment [IGA] score and score of 'clear' or 'almost clear'), treatment success in psoriasis signs (erythema, plaque elevation, and scaling) at the target lesion, and change in affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated. Results: At week 8, rates of IGA-rated treatment success were significantly greater for HP versus vehicle in males (34.0% vs 6.4%) and females (42.7% vs 14.6%; P<0.001 both). Treatment success in each psoriasis sign approached or exceeded 50% for HP-treated males and females, with all differences versus vehicle statistically significant (P<0.001). Percent reduction in affected BSA was significantly greater for HP versus vehicle in males (34.9% vs 6.7%) and females (35.6% vs 4.6%; P<0.001 both). Five HP treatment-related TEAEs (all application site-related) were reported through week 8. Conclusions: HP lotion was associated with significant reductions in disease severity in male and female participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks of once-daily use. In the overall pooled population, results were similar. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5250.
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27
J Drugs Dermatol
. 2020 Oct 1;19(10):943-948. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5422.
Impact of Atopic Dermatitis Lesion Location on Quality of Life in Adult Patients in a Real-world Study
Peter A Lio, Andreas Wollenberg, Jacob P Thyssen, Evangeline J Pierce, Maria Jose Rueda, Amy M DeLozier, Jorge Alfonso Ross Terres, Peter Anderson, Gary Milligan, James Piercy, Jonathan I Silverberg, Carle Paul
PMID: 33026770
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5422
Abstract
Background: Atopic dermatitis (AD) has a negative impact on patients’ quality of life (QoL).
Objective: To report the impact of specific AD lesion locations on QoL in adult patients with AD using real-world data.
Methods: The Adelphi US Disease Specific Programme was conducted between January–April 2018. Physicians documented patient demographics/characteristics, AD lesion locations, and body surface area; patients completed questionnaires reporting the impact of lesion locations on QoL.
Results: AD severity was moderate in 51.6% of patients and severe in 6.0%. Lesions were commonly identified in more than one location. All AD lesion locations impacted QoL. Visible areas were most bothersome, including head/neck (68%), hands/fingers (58%), front (30%), upper extremities (22%), and lower extremities (16%), with statistically significant associations for a number of Dermatology Life Quality Index (DLQI) items. Itch, soreness, pain, and stinging are also associated with a number of body areas but in particular with those that are most visible/accessible. Lesions on the head/neck and hands/fingers (58%) demonstrated an increased impact on the anxiety and depression dimension of the EuroQol 5-Dimension tool.
Conclusions: In patients with AD, quality of life was most affected in patients with lesions in visible areas, including head/neck, hands/fingers, and upper extremities, with statistically significant associations for a number of DLQI domains. Physicians should be aware of the burden of AD lesions on QoL and consider having conversations with patients to better understand the impact of these lesions. Prior presentation: 28th Annual European Academy of Dermatology and Venereology Congress; 9–13 October 2019, Madrid, Spain. Poster number P0233.J Drugs Dermatol. 2020;19(10): 943-948. doi:10.36849/JDD.2020.5422.
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28
J Drugs Dermatol
. 2020 Oct 1;19(10):950-955. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5090.
Development and Evaluation of an Atopic Dermatitis Care Plan for Providers
Collette Utley, Michael H Gold, Melissa Hall
PMID: 33026765
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5090
Abstract
Background/Significance of problem: Atopic Dermatitis (AD) is a common, chronic, inflammatory dermatosis and skin disease that follows a relapsing pattern and requires a dynamic stepwise approach to management.Providers feel comfortable treating chronic disease states with a guided tool or care plan in many chronic diseases.Care plans used in many chronic diseases such as asthma, diabetes, and COPD have demonstrated effectiveness in disease and healthcare provider management.There is an unmet need for a universal AD care plan for providers. Clinical question/project purpose: A universal AD care plan was developed to improve AD disease management and patient outcomes. Post-implementation of providers’ perceptions was assessed for how the AD universal care plan affected their ability to provide patient education. Search of literature/best evidence: Review of literature includes: CINAHL, ProQuest Health, PubMed, Fusion, and UpToDate databases from 2008-2018.Search terms included: Atopic Dermatitis, Eczema, care plans, care plan use in chronic disease. Clinical appraisal of literature/best evidence: Analysis of the evidence supported the need for AD education, which then supported the need for a universal AD care plan for providers. Integration into practice: “Your Eczema Care Plan” was used by thirty-five healthcare providers to improve patient outcomes in a similar manner as other evidence-based care plans.Evaluation of evidenced-based practice: Post-implementation of providers’ perceptions were evaluated on how the AD care plan tool affected their ability to provide patient education. Results suggest patient education, disease management, and QOL are all improved when utilizing “Your Eczema Action Plan.” J Drugs Dermatol. 2020;19(10): 950-955. doi:10.36849/JDD.2020.5090.
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29
J Drugs Dermatol
. 2020 Sep 1;19(9):829-832. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5084.
Complication of Soft Tissue Fillers: Prevention and Management Review
Hassan Galadari, George Krompouzos, Martin Kassir, Mrinal Gupta, Uwe Wollina, Andreas Katsambas, Torello Lotti, Mohammad Jafferany, Alexander A Navarini, Roberta Vasconcelos Berg, Stephan Grabbe, Mohamad Goldust
PMID: 33026743
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5084
Abstract
The use of dermal fillers has increased manifold over the past decade, which has been attributed to the ever-increasing need of the population for being young. Fillers have become quite popular both among patients and treating physicians due to their quick and quite predictable results. Filler injection is a safe procedure in the hands of an experienced provider using appropriate technique. Nevertheless, various adverse effects to fillers have been reported that range from mild injection site complications, such as pain and bruising, to severe complications, like tissue necrosis, retinal artery occlusion, and infections. The esthetic provider should be aware of and be able to quickly recognize such complications, and be confident in managing them. In this article we highlight the various adverse effects noted with the use of fillers and discuss prevention and management. J Drugs Dermatol. 2020;19(9):829-832. doi:10.36849/JDD.2020.5084.
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30
J Drugs Dermatol
. 2020 Sep 1;19(9):874-880. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5020.
Efficacy and Safety of Calcipotriene 0.005%/Betamethasone Dipropionate 0.064% Foam With Apremilast for Moderate Plaque Psoriasis
Leon H Kircik, Todd E Schlesinger, Emil Tanghetti
PMID: 33026749
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5020
Abstract
Objective: To demonstrate the efficacy and safety of adding fixed-dose combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam to oral apremilast in treating moderate plaque psoriasis.
Methods: A 16-week, investigator-blinded study in patients with moderate psoriasis (Physician’s Global Assessment [PGA] score of 3). Patients were randomized 1:1 to Cal/BD foam plus apremilast or vehicle foam plus apremilast for 4 weeks, followed by 8 weeks of apremilast monotherapy, and then 4 weeks of combination therapy as in the original randomization schedule. Efficacy assessments – Psoriasis Area and Severity Index (PASI), PGA, body surface area (BSA), visual analog scale (VAS) for pruritus, and quality of life (QoL) – and safety were evaluated at weeks 1, 2, 3, 4, 12, and 16.
Results: 28 subjects were enrolled (mean age, 64 years; 67.9% males). Cal/BD foam plus apremilast group achieved statistically significantly greater improvement than vehicle foam plus apremilast in PASI75 (50% vs 7%; P=.003), PGA score of “clear” or “almost clear” (43% vs 7%; P=.001), and VAS score (2 vs 5; P=.0079) at week 4. BSA and QoL improvements were also observed. Most efficacy assessments worsened after withdrawing Cal/BD foam for 8 weeks but recovered after reinitiating Cal/BD foam from week 12 to week 16. Cal/BD foam plus apremilast appeared to be safe and well tolerated.
Conclusions: In the treatment of moderate plaque psoriasis, Cal/BD foam plus apremilast provided more benefits than with apremilast alone. These improvements appeared to be lost when Cal/BD foam was withdrawn but recovered when Cal/BD foam was reinitiated. J Drugs Dermatol. 2020;19(9):874-880. doi:10.36849/JDD.2020.5020.
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31
Editorial
J Drugs Dermatol
. 2020 Aug 1;19(8):803-805. doi: 10.36849/JDD.2020.4943.
Cutaneous Langerhans Cell Histiocytosis Responsive to Topical Nitrogen Mustard
Ai-Tram N Bui, Ashleigh Eberly Puleo, Alvaro Laga Canales, Eric D Jacobsen, Nicole R LeBoeuf
PMID: 32845598
DOI: 10.36849/JDD.2020.4943
Abstract
Langerhans cell histiocytosis (LCH) limited to the skin is rare in adult patients. Given the challenges of prospective clinical trials for this rare disease, there is paucity in data to guide the management of cutaneous LCH. Topical nitrogen mustard is a possible treatment for cutaneous LCH with positive responses in five known adult cases in the literature. In this report, we present two adult patients with recalcitrant cutaneous LCH and no evidence of systemic involvement who had rapid and complete response on topical nitrogen mustard therapy. We provide support for topical nitrogen mustard as a treatment option for primary cutaneous LCH which may spare patients from requiring systemic immunosuppressive treatments. J Drugs Dermatol. 2020;19(8):803-805. doi:10.36849/JDD.2020.4943.
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32
Editorial
J Drugs Dermatol
. 2020 Aug 1;19(8):807-808. doi: 10.36849/JDD.2020.5138.
One-Year Pharmacovigilance Update of Brodalumab
Mark Lebwohl, Craig Leonardi, Jashin J Wu, Paul Yamauchi, Nicole Rawnsley, Mohammed Merchant, Binu Alexander, Abby Jacobson
PMID: 32845586
DOI: 10.36849/JDD.2020.5138
No abstract available
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33
J Drugs Dermatol
. 2020 Oct 1;19(10):s8-s11.
ARTICLE: Colloidal Oatmeal Part II: Atopic Dermatitis in Special Populations and Clinical Efficacy and Tolerance Beyond Eczema
Blair Allais, Adam Friedman
PMID: 33026769
Abstract
Colloidal oatmeal has a diverse array of applications, clinical benefits, and uses beyond atopic dermatitis. First and foremost, it has been shown to be of benefit in the treatment of atopic dermatitis in skin of color. It has also been shown to be of benefit in the treatment of hand dermatitis, xerosis, psoriasis, skin manifestations of diabetes, and in the treatment of cutaneous adverse effects associated with oncologic therapies. In Part II of this 2-part series, we examine the efficacy, safety, and expansive clinical applications of colloidal oatmeal. J Drugs Dermatol. 2020;19:10(Suppl):s8-11.
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34
J Drugs Dermatol
. 2020 Sep 1;19(9):822-827. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5353.
Randomized, Double-Blinded, Split-Face Study Comparing the Efficacy and Tolerability of Two Topical Products for Melasma
Bridget P Kaufman, Andrew F Alexis
PMID: 33026755
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5353
Abstract
Background: Melasma is a common disorder of hyperpigmentation that disproportionately affects individuals with skin of color. There is a paucity of studies evaluating non-hydroquinone (HQ) topical therapies for the treatment of melasma in darker skin types.
Objective: To compare the safety, efficacy, and tolerability of a HQ-free, retinol-free cosmetic topical brightener (CTB) and HQ 4% in the treatment of moderate symmetric facial melasma in patients with Fitzpatrick skin types (FST) III–VI. Methods & Materials: This was a randomized, double-blinded, split-face clinical trial. Eighteen adult patients with facial melasma were treated with CTB and HQ 4%, each to a different side of the face, twice daily for 12 weeks. Clinical assessments included half-face Melasma Area Severity Index (MASI), Overall Hyperpigmentation scale, and Melasma Severity Rating Scale (MSRS). Patients completed a Melasma Quality of Life (MelasQoL) questionnaire and clinical photographs were taken at each visit.
Results: CTB and HQ 4% demonstrated statistically significant improvements in half-face MASI, Overall Hyperpigmentation, MSRS and MelasQol compared to baseline. HQ 4% showed statistically significant improvements in MSRS at week 12 compared to CTB, but was non-superior for all other clinical endpoints.
Conclusion: HQ-free, retinol-free CTB and HQ 4% both are effective and well-tolerated in the treatment of moderate facial melasma in FST III–VI. J Drugs Dermatol. 2020;19(9):822-827. doi:10.36849/JDD.2020.5353.
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35
J Drugs Dermatol
. 2020 Aug 1;19(8):723-732. doi: 10.36849/JDD.2020.5300.
Fixed Combination Calcipotriene and Betamethasone Dipropionate (Cal/BD) Foam for Beyond-Mild Psoriasis: A Possible Alternative to Systemic Medication
Leon Kircik, Linda Stein Gold, Joyce Teng, Angela Moore, Wendy Cantrell, Javier Alonso-Llamazares, John Koo
PMID: 32845591
DOI: 10.36849/JDD.2020.5300
Abstract
Calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) aerosol foam is a topical agent indicated for the treatment of plaque psoriasis. While topical treatments are typically reserved for milder disease, in clinical trials with Cal/BD foam, the vast majority of patients had beyond-mild psoriasis at baseline, and multiple studies (including subgroup analyses from randomized controlled trials and other small-scale studies) have demonstrated favorable outcomes with the use of Cal/BD foam in this population. The objective of this article is to review existing data on the efficacy, safety, and cost-effectiveness of Cal/BD foam used in patients with beyond-mild psoriasis, either alone as topical monotherapy or as adjunctive therapy. Practical recommendations for managing beyond-mild psoriasis with Cal/BD foam are also provided. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5300.
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36
J Drugs Dermatol
. 2020 Oct 1;19(10):1000-1004. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5347.
Successful Management of a Black Male With Psoriasis and Dyspigmentation Treated With Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion: Case Report
Seemal R Desai, Andrew F Alexis, Abby Jacobson
PMID: 33026772
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5347
Abstract
Skin of color patients with psoriasis face unique challenges related to disease characteristics and treatment. Dyspigmentation, including postinflammatory hypo- and hyperpigmentation, more frequently and severely affects patients with skin of color and remains a challenge in psoriasis management. We present the case of a 58-year-old Black male with moderate psoriasis who was treated for 8 weeks with a fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion during a phase 3 study (NCT02462070). HP/TAZ was efficacious in this patient, whose Investigator’s Global Assessment score decreased from 3 (moderate) at baseline to 1 (almost clear) within 4 weeks, with maintenance of “almost clear” through week 12 (4 weeks posttreatment). Affected body surface area decreased by 50% and quality of life greatly improved from baseline to week 8. The patient experienced dyspigmentation of the affected skin during the trial; hypopigmentation was primarily experienced from weeks 2–8, with the greatest degree at week 4. By week 12, the affected skin area had returned to normal, with only small regions of hyperpigmentation, primarily around the periphery of the lesion. These results indicate that HP/TAZ may be a treatment option for patients with skin of color, who are disproportionally affected by postinflammatory dyspigmentation. J Drugs Dermatol. 2020;19(10):1000-1004. doi:10.36849/JDD.2020.5347.
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37
J Drugs Dermatol
. 2020 Sep 1;19(9):894-896. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5275.
Cutaneous Manifestations of EGFR-Inhibitors in African Americans and Treatment Considerations
Amaris N Geisler, Sarah J Noor
PMID: 33026750
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5275
Abstract
Epidermal growth factor (EGFR)-inhibitors have emerged as the primary therapy in advanced solid tumor malignancies because of improvement in survival with overall favorable side effect profile. However, 50–90% of patients treated with EGFR-inhibitors develop a follicular or acneiform rash, which can be symptomatic and source of psychosocial distress, negatively impacting quality of life. As this acneiform rash is a well-recognized cutaneous toxicity of EGFR-inhibitors, a treatment algorithm has been proposed for management based on severity. However, treatment options for EGFR-inhibitor induced rash may not be generalizable to African Americans whose differences in skin biology and sensitivity present pathophysiologic challenges. Herein, we present a case of an African American patient who developed this acneiform rash while on cetuximab. We also review the few cases that have been reported in the literature of EGFR-inhibitor rash in African Americans, highlighting important management considerations in this patient population. J Drugs Dermatol. 2020;19(9):894-896. doi:10.36849/JDD.2020.5275.
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38
Editorial
J Drugs Dermatol
. 2020 Aug 1;19(8):799-801. doi: 10.36849/JDD.2020.5388.
The State of Sunscreens in the US: Caveat Emptor
Lisa Akintilo, Ellen Gendler
PMID: 32845592
DOI: 10.36849/JDD.2020.5388
No abstract available
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39
Editorial
J Drugs Dermatol
. 2020 Aug 1;19(8):795. doi: 10.36849/JDD.2020.5229.
Topical Cannabinoids for the Management of Psoriasis Vulgaris: Report of a Case and Review of the Literature
Adam J Friedman, Kimia Momeni, Mikhail Kogan
PMID: 32845594
DOI: 10.36849/JDD.2020.5229
No abstract available
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40
Editorial
J Drugs Dermatol
. 2020 Aug 1;19(8):797-798. doi: 10.36849/JDD.2020.401.
Telemedicine Platforms Used in Academic Dermatology During the COVID-19 Pandemic: Implications for Adaptation and Usage
Jacob Beer, Michael Abrouk, Robert Kirsner
PMID: 32845113
DOI: 10.36849/JDD.2020.401
No abstract available
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41
J Drugs Dermatol
. 2020 Oct 1;19(10):s4-s7.
ARTICLE: Colloidal Oatmeal Part I: History, Basic Science, Mechanism of Action, and Clinical Efficacy in the Treatment of Atopic Dermatitis
Blair Allais, Adam Friedman
PMID: 33026768
Abstract
Colloidal oatmeal has a long-standing history in the treatment of dermatologic disease. It is composed of various phytochemicals, which contribute to its wide-ranging function and clinical use. It has various mechanisms of action including direct anti-inflammatory, anti-pruritic, anti-oxidant, anti-fungal, pre-biotic, barrier repair properties, and beneficial effects on skin pH. These have been shown to be of particular benefit in the treatment of atopic dermatitis. In Part 1 of this two-part series, we will explore the history of colloidal oatmeal, basic science, mechanism of action, and clinical efficacy in the treatment of atopic dermatitis. J Drugs Dermatol. 2020;19:10(Suppl):s4-7.
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42
J Drugs Dermatol
. 2020 Sep 1;19(9):858-864. doi: 10.36849/JDD.2020.10.36849/JDD.2020.5259.
The Impact of COVID-19 on the Faces of Frontline Healthcare Workers
Shino Bay Aguilera, Irene De La Pena, Martha Viera, Bertha Baum, Brian W Morrison, Olivier Amar, Matthieu Beustes-Stefanelli, Mehreen Hall
PMID: 33026745
DOI: 10.36849/JDD.2020.10.36849/JDD.2020.5259
Abstract
As the coronavirus epidemic continues, a host of new cutaneous complications is seen on the faces of frontline healthcare workers wearing personal protective equipment on a daily basis. To minimize the risk of COVID-19 infection, healthcare workers wear tight-fitting masks that lead to an excessive amount of pressure on the facial skin. Mechanical pressure, mask materials, and perspiration can all lead to various types of cutaneous lesions such as indentations of the face, skin tears, post-inflammatory hyperpigmentation, ulceration, crusting, erythema, and infection. The objective of this article is to provide effective and straightforward recommendations to those health care providers using facial masks in order to prevent skin-related complications. J Drugs Dermatol. 2020;19(9):858-864. doi:10.36849/JDD.2020.5259.
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43
J Drugs Dermatol
. 2020 Oct 1;19(10):1005-1007.
Persistent Agminated CD30+ Lymphoproliferative Disorder
Jacob Beer, Peter G Bittar, Julie M Bittar, Rosalie Elenitsas, Paul Haun
PMID: 33026773
No abstract available
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44
J Drugs Dermatol
. 2020 Oct 1;19(10):1009-1010.
Is TNF-α Inhibitor-Induced Psoriasiform Dermatitis Always Psoriasiform?
Chapman Wei, Emily C Murphy, Joseph Zahn, Adam J Friedman
PMID: 33026774
No abstract available
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45
J Drugs Dermatol
. 2020 Sep 1;19(9):900-903.
The Impact of Pharmacy Benefit Managers on Drug Pricing
Dillon J Patel, Neal Bhatia, Mark D Kaufmann
PMID: 33026747
No abstract available
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46
J Drugs Dermatol
. 2020 Sep 1;19(9):905-906.
Exchanging Dermatoscopes for Stethoscopes: Has the COVID-19 Pandemic Highlighted Gaps in US Dermatology Residency Training?
Katharina S Shaw, Theodora K Karagounis, Lu Yin, Katerina Svigos, Grace T Gibbon, Rebecca A Betensky, Kristen I Lo Sicco
PMID: 33026742
No abstract available
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