Abstract
Objective: Controlling molluscum contagiosum (MC) infections is critical in atopic dermatitis (AD) management. This post hoc analysis assessed the efficacy and safety of berdazimer gel, 10.3% (topical, antiviral, nitric oxide–releasing medication) versus vehicle in MC patients with or without AD. Methods: Three Phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group trials (B-SIMPLE[berdazimer sodium in molluscum patients with lesions]1, −2, −4) enrolled patients 6 months and older with 3–70 mollusca. Berdazimer or vehicle was applied once daily to all MC lesions for 12 weeks. Data from three Phase 3 studies were integrated for subgroup efficacy and safety assessments using several weighted meta-analysis approaches. Patients with concurrent AD or a history of AD/eczema were categorized as AD+ subgroup (AD− when absent). Primary efficacy endpoint: complete lesion clearance at Week 12. Safety endpoints included adverse events (AEs) through Week 24 and local skin reactions through Week 12. Results: Of 1598 enrolled patients, 209 (13.1%) were AD+. Baseline mean lesion counts were greater in AD+ (26.4) than AD− (19.3). Complete clearance rates were higher at Week 12 for berdazimer compared with vehicle in AD+ (n = 209; 35.0% vs. 27.4%; odds ratio [OR], 1.3; 95% CI, 0.7–2.5) and AD− (n = 1389; 29.1% vs. 18.9%; OR 1.8; 95% CI 1.4–2.4) subgroups. AEs in AD+ were application-site pain (21.6% with berdazimer vs. 11.9% with vehicle), dermatitis (12.8% vs. 2.4%), and erythema (9.6% vs. 7.1%). Conclusions: Berdazimer gel showed favorable efficacy regardless of AD status. Berdazimer-induced erythema may be indistinguishable from AD symptoms or with inflammatory response upon resolution of molluscum.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 438-444 |
| Number of pages | 7 |
| Journal | Pediatric dermatology |
| Volume | 41 |
| Issue number | 3 |
| DOIs | |
| State | Published - May 1 2024 |
Funding
The authors are grateful to the patients and caregivers who gave the gift of clinical research participation. In addition, we thank all B-SIMPLE clinical program investigators and study site personnel for their contributions. Dana L. Randall, MS, PharmD, provided editorial support for the manuscript that was funded by Novan, Inc. Novan, Inc. also funded the individual studies and the integrated analysis. Dr. Paller is an investigator for AbbVie, Dermavant, Eli Lilly, Incyte, Janssen, Krystal, Novan, and UCB, has received honoraria from Aegerion Pharma, Azitra, BioCryst, Boehringer\u2010Ingelheim, Bristol Myers Squibb, Castle Creek, Eli Lilly, Janssen, Krystal, LEO Pharma, Novartis, Regeneron, Sanofi/Genzyme, Seanergy, TWI Biotechnology, and UCB, and serves on the data safety monitoring boards for AbbVie, Abeona, Catawba, Galderma, and InMed. Dr. Green is an investigator and consultant for Novan and a consultant, investigator, or speaker for Amgen, Alumis, Arcutis, Alumis, BMS, Candesant, Cara, Dermavant, Endo, EPI Health, Galderma, Highlittl, Incyte, Janssen, Lilly, OrthoDerm, and Verrica. Dr. Silverberg has received honoraria from Sanofi/Regeneron, Novan, Verrica, Pfizer, and Incyte. Dr. Stripling is an advisor for Novan and an investigator for Arcutis Biotherapeutics and Novan. Drs. Cartwright and Maeda\u2010Chubachi and Ms. Enloe are employees of and stockholders in Novan, Inc. Mr. Wells is an employee of Synteract, which received funding from Novan, Inc. for the statistical analysis. Kowalewski is an intern at Novan, Inc. and a Graduate Research Assistant at the University of North Carolina at Chapel Hill (UNC\u2010CH); she received a grant from Novan, Inc. for a collaborative biostatistics agreement with UNC\u2010CH.
Keywords
- atopic dermatitis
- berdazimer
- molluscum contagiosum
- nitric oxide
- pediatrics
- topical administration
ASJC Scopus subject areas
- Pediatrics, Perinatology, and Child Health
- Dermatology