PMID- 38413239
OWN - NLM
STAT- Publisher
LR  - 20240227
IS  - 1525-1470 (Electronic)
IS  - 0736-8046 (Linking)
DP  - 2024 Feb 27
TI  - Berdazimer gel for molluscum contagiosum in patients with atopic dermatitis.
LID - 10.1111/pde.15575 [doi]
AB  - 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.
CI  - (c) 2024 Novan, A Ligand Company. Pediatric Dermatology published by Wiley 
      Periodicals LLC.
FAU - Paller, Amy S
AU  - Paller AS
AUID- ORCID: 0000-0001-6187-6549
AD  - Department of Dermatology, Northwestern University Feinberg School of Medicine 
      and the Ann and Robert H. Lurie Children's Hospital, Chicago, Illinois, USA.
FAU - Green, Lawrence J
AU  - Green LJ
AUID- ORCID: 0000-0002-1295-9249
AD  - Department of Dermatology, George Washington University School of Medicine, 
      Washington, DC, USA.
FAU - Silverberg, Nanette
AU  - Silverberg N
AUID- ORCID: 0000-0002-4274-7597
AD  - Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New 
      York, USA.
FAU - Stripling, Stephen
AU  - Stripling S
AUID- ORCID: 0009-0006-8244-7210
AD  - Pediatric Department, Coastal Pediatric Research, Charleston, South Carolina, 
      USA.
FAU - Cartwright, Martina
AU  - Cartwright M
AUID- ORCID: 0000-0001-7207-2810
AD  - Novan, Inc., Durham, North Carolina, USA.
FAU - Enloe, Carolyn
AU  - Enloe C
AUID- ORCID: 0000-0001-5021-9201
AD  - Novan, Inc., Durham, North Carolina, USA.
FAU - Wells, Nick
AU  - Wells N
AD  - Synteract, Hampshire, UK.
FAU - Kowalewski, Elaine Kearney
AU  - Kowalewski EK
AUID- ORCID: 0000-0002-7915-877X
AD  - Gillings School of Global Public Health, University of North Carolina, Chapel 
      Hill, North Carolina, USA.
FAU - Maeda-Chubachi, Tomoko
AU  - Maeda-Chubachi T
AUID- ORCID: 0000-0002-3614-1505
AD  - Novan, Inc., Durham, North Carolina, USA.
LA  - eng
GR  - Novan Inc/
PT  - Journal Article
DEP - 20240227
PL  - United States
TA  - Pediatr Dermatol
JT  - Pediatric dermatology
JID - 8406799
SB  - IM
OTO - NOTNLM
OT  - atopic dermatitis
OT  - berdazimer
OT  - molluscum contagiosum
OT  - nitric oxide
OT  - pediatrics
OT  - topical administration
EDAT- 2024/02/28 00:43
MHDA- 2024/02/28 00:43
CRDT- 2024/02/27 21:53
PHST- 2023/12/12 00:00 [received]
PHST- 2024/02/13 00:00 [accepted]
PHST- 2024/02/28 00:43 [medline]
PHST- 2024/02/28 00:43 [pubmed]
PHST- 2024/02/27 21:53 [entrez]
AID - 10.1111/pde.15575 [doi]
PST - aheadofprint
SO  - Pediatr Dermatol. 2024 Feb 27. doi: 10.1111/pde.15575.