Calcitonin Gene-Related Peptide Inhibition and Development of Acne and Rosacea.

This cohort study investigates whether calcitonin gene-related peptide inhibition is associated with reduced rates of developing acne or rosacea in patients who experience migraines.

Challenges in designing a randomized, double-blind noninferiority trial for treatment of acne: The SD-ACNE trial.

BACKGROUND/AIMS: Excessive use of antibiotics has led to development of antibiotic resistance and other antibiotic-associated complications. Dermatologists prescribe more antibiotics per clinician than any other major specialty, with much of this use for acne. Alternative acne treatments are available but are used much less often than antibiotics, at least partially because dermatologists feel that they are less effective. Spironolactone, a hormonal therapy with antiandrogen effects that can address the hormonal pathogenesis of acne, may represent a therapeutic alternative to oral antibiotics for women with acne. However, the comparative effects of spironolactone and oral antibiotics in the treatment of acne have not been definitively studied. The Spironolactone versus Doxycycline for Acne: A Comparative Effectiveness, Noninferiority Evaluation (SD-ACNE) trial aims to answer whether spironolactone, in addition to standard topical therapy, is noninferior to doxycycline (an oral antibiotic) for women with acne. Several interesting challenges arose in the development of this study, including determining acceptability of the comparative regimens to participating dermatologists, identifying data to support a noninferiority margin, and establishing a process for unblinding participants after they completed the study while maintaining the blind for study investigators. METHODS: We present the scientific and clinical rationale for the decisions made in the design of the trial, including input from key stakeholders through a Delphi consensus process. RESULTS: The Spironolactone versus Doxycycline for Acne: A Comparative Effectiveness, Noninferiority Evaluation trial (NCT04582383) is being conducted at a range of community and academic sites in the United States. To maximize external validity and inform clinical practice, the study is designed with broad eligibility criteria and no prohibition of use of topical medications. Participants in the trial will be randomized to receive either spironolactone 100 mg/day or doxycycline hyclate 100 mg/day for 16 weeks. The primary outcome is the absolute decrease in inflammatory lesion count, and we have established a noninferiority margin of four inflammatory lesions. Secondary outcomes include the percentage of participants achieving Investigator Global Assessment success, change in quality of life, and microbiome changes and diversity. CONCLUSIONS: The Spironolactone versus Doxycycline for Acne: A Comparative Effectiveness, Noninferiority Evaluation trial will have substantial implications for the treatment of acne and antibiotic stewardship. In addition, this study will provide important information on the effect of these systemic agents on the development of changes to the microbiome and antibiotic resistance in a healthy population of patients.

Reconstruction after Mohs Surgery for Digit Melanoma: Description of Techniques and Postoperative Limb Function.

Introduction: Mohs surgery and reconstruction has enabled tissue-preserving resection of cutaneous malignancies. The goal of our case series evaluation is to present reconstructive techniques and functional outcomes in patients undergoing digit-sparing treatment for primary melanoma. Materials and Methods: A chart review was performed to identify consecutive patients undergoing Mohs surgery and reconstruction for melanoma of the digits. Quality of life (QOL) survey was performed to assess function after the procedure. Results: Thirty-two patients (13 hand, 19 foot, Age: 65.03 +/-17.78 years) who were undergoing Mohs surgery were identified. No recurrence was identified with an average follow-up of 16.1 months (1-95 months). The average defect size was 5.79 +/-4.54 cm2. Reconstruction was performed 0-4 days after resection. The most common techniques included full-thickness skin graft (FTSG) (N = 7), collagen matrix + FTSG (N = 4), and volar advancement flap (N = 7). The reconstructive technique choice appears correlated with defect size (p = 0.0125). Neuro-QOL upper extremity survey results showed a difference that approached statistical significance between patients who underwent digit-sparing treatment (n = 7) versus direct to amputation controls (n = 5) (p = 0.072). No survey differences between digit-sparing treatment (n = 10) and amputation (n = 8) were identified in the lower extremity (p = 0.61). Conclusion: Our results show digit-sparing treatment can confirm clear surgical margins and a trend toward improvement in upper extremity function compared with immediate amputation.

Antibiotic adherence in dermatologic surgery: a Multicenter prospective cohort study.

Understanding patient non-adherence to prescribed antibiotics can inform clinical practices, patient counseling, and antibiotic efficacy study design in dermatology. The primary objective was to determine the rate of and reasons for antibiotic non-adherence in the dermatologic surgery setting. The secondary objective was to test the applicability of previously studied survey questions for antibiotic non-adherence screening in the dermatologic surgery setting. Five academic outpatient dermatologic surgery centers across the United States conducted one multicenter prospective cohort study. Dermatologic surgery patients ≥ 18 years of age who were prescribed an antibiotic were included as part of this study. 15.2% (42/276) of patients did not adhere to their antibiotic regimen after dermatologic surgery. Most common reasons for incomplete antibiotic courses included forgotten antibiotics (42.9%,18/42) and side effects (28.6%, 12/42). Previously evaluated questions to identify and predict non-adherence had modest performance in the dermatologic surgery setting (Area under the curve of 0.669 [95% CI (0.583-0.754)]). Antibiotic non-adherence after skin surgery is prevalent and commonly due to reasons that physicians can address with patients.

Barriers to care and health-related quality of life among US adults with several common chronic inflammatory skin diseases: a cross-sectional analysis of the NIH All of Us Research Program.

Research investigating the impact of barriers to care on health-related quality of life (HRQoL) among US adults with chronic inflammatory skin diseases (CISDs) is limited. In this study, we utilize multivariable-adjusted logistic regression to analyze the associations between cost barriers (e.g., delaying specialist and mental health care due to cost) and non-cost barriers (e.g., delaying care due to transportation issues and the lack of provider diversity) with HRQoL among US adults with several common CISDs in the National Institutes of Health's All of Us Research Program (AoURP). Among the 19,208 adults with CISDs included in our analysis, the prevalence of poorer HRQoL(i.e., "fair" or "poor" HRQoL) was significantly higher among adults with CISDs who experienced cost (aOR, 2.39;95% CI, 2.10-2.73) and non-cost barriers (aOR, 2.52; 95% CI, 2.20-2.88) than those with CISDs who did not experience those barriers. Since dermatologists are often the only physician caring for patients with CISDs, this study reinforces the critical role dermatologists have in addressing social determinants of health and advocating to reduce cost and non-cost barriers for their patients with CISDs.

Isotretinoin for Acne in Transgender and Gender-Diverse Individuals Receiving Masculinizing Hormone Therapy.

Importance: Masculinizing gender-affirming hormonal therapy is associated with the development of acne. While isotretinoin is a highly effective acne treatment, little is known about its effectiveness and safety among transgender and gender-diverse individuals receiving gender-affirming hormonal therapy. Objective: To evaluate clinical outcomes of isotretinoin among transgender and gender-diverse individuals receiving gender-affirming hormonal therapy. Design, Setting, and Participants: This multicenter retrospective case series study was conducted at 4 medical centers: Mass General Brigham, University of Pennsylvania, Emory University, and Fenway Health. It included patients aged between 12 and 49 years who were receiving masculinizing gender-affirming hormonal therapy and prescribed isotretinoin for the management of acne between August 14, 2015, and September 20, 2023. Exposure: Isotretinoin therapy for the management of acne. Main Outcomes and Measures: The percentage of patients experiencing improvement or clearance of acne, as well as rates of acne recurrence. Adverse effects and reasons for treatment discontinuation were also evaluated. Results: Among 55 included patients, the mean (SD) age was 25.4 years; 4 (7.3%) were Asian, 2 (3.6%) were Black, 4 (7.2%) were Hispanic, 1 was (1.8%) multiracial, and 36 (65.5%) were White. The median isotretinoin course duration was 6 months (IQR, 4.0-8.0), with a median cumulative dose of 132.7 mg/kg (IQR, 66.4-168.5); the cumulative dose was less than 90 mg/kg for 16 patients (29.1%) and less than 120 mg/kg for 22 patients (40.0%). Isotretinoin was associated with improvement in 48 patients (87.3%) and clearance in 26 patients (47.3%). For the 33 patients treated with a cumulative dose of 120 mg/kg or more, these rates increased to 32 patients (97.0%) and 21 patients (63.6%), respectively. Among the 20 patients who achieved acne clearance and had any subsequent health care encounters, the risk of recurrence was 20.0% (n = 4). The most frequently reported adverse effects were dryness (n = 44; 80.0%), joint pain (n = 8; 14.5%), and eczema (n = 5; 9.1%). Laboratory abnormalities were uncommon. Reasons for premature treatment discontinuation included cost, pharmacy issues, adverse effects, logistical reasons (scheduling), and wound healing concerns for gender-affirming surgery. Conclusion and Relevance: In this case series study of individuals with acne who were receiving masculinizing gender-affirming hormonal therapy and underwent isotretinoin treatment, isotretinoin was often effective and well tolerated. However, premature treatment discontinuation was common and associated with poorer outcomes. Further efforts are needed to understand optimal dosing and treatment barriers to improve outcomes in transgender and gender-diverse individuals receiving masculinizing gender-affirming hormonal therapy.

Understanding patient perspectives on vaccine decision making in adults with autoimmune bullous diseases: a qualitative study.

Patients with autoimmune bullous diseases are at an increased risk of infection, both from the underlying skin disease and from immunosuppressive treatments. Limited information is available on vaccine beliefs and behaviors in dermatology patients and adults with autoimmune bullous diseases in particular. To understand vaccine decision making, identify perceived risks and benefits of vaccinations, and discuss individual experiences in patients with autoimmune bullous diseases in the United States. A qualitative study was performed utilizing semi-structured interviews, and analysis was conducted on NVivo. Patterns were identified in the coded data, and representative quotations were recorded for each major theme. Interviews were conducted between February 15, 2022 and September 15, 2022. Twenty patients with a diagnosis of bullous pemphigoid, mucous membrane pemphigoid, pemphigus vulgaris, or pemphigus foliaceous were interviewed. Of the 20 participants, 14 (70%) were female, with a mean (SD, range) age of 64.8 (13.2, 34-83) years. Key themes that emerged from qualitative analysis of the interviews included patient concerns regarding their increased susceptibility to infection, potential exacerbation of skin disease following vaccination, and the effect of immunosuppressive medications on humoral response to vaccines. Lack of appointment availability, difficulty accessing vaccines, and cost were commonly identified barriers to vaccination. These findings provide valuable knowledge for dermatologists in regard to providing counseling specific to patient concerns and to improve communication surrounding vaccination in the dermatology setting.