NCT05536882

MC RCT - BPO vs Adapalene

Randomized Controlled Trial Comparing the Efficacy of Adapalene 0.1% Gel to 10% Benzoyl Peroxide in Treating Molluscum Contagiosum.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 1 Year – 14 Years
• Healthy volunteers: Not accepted

Summary

Non-blinded randomized controlled trial comparing efficacy of topical benzoyl peroxide 10% (vehicle choice per patient preference: e.g. gel, cream, lotion, wash) to topical adapalene 0.1% gel in the treatment of molluscum contagiosum in children aged 1 year old to 14 years old. * Two treatment wings: topical benzoyl peroxide 10% (vehicle choice per patient preference) applied 1-2x daily as tolerated vs adapalene 0.1% gel applied 1-2x daily as tolerated. * Primary outcome: Complete clearance at 12wks (defined as lack of identifiable papular molluscum contagiosum lesions on physical exam) * Secondary outcomes: % change in lesion count at 12wks.

Detailed description

* During the course of their normal workday, OU dermatology faculty and residents will be responsible for identifying and recruiting treatment-naïve patients being seen at the OU dermatology clinic for the diagnosis of molluscum contagiosum. These same faculty and residents will be responsible for approaching these patients regarding participation in the study. Chart review will not be a part of this selection process aside from what would naturally be done in the course of the patients' care. The same faculty and residents would be responsible for explaining the risks and benefits of study participation, obtaining written consent for study participation from a parent or guardian, obtaining verbal assent from patients aged 7-14 years old (as well as written assent for those capable of reading/writing), and randomizing patients to respective treatment wings using an online random number generator. * \# of MC lesions counted at time of recruitment, re-assessed at single follow up appointment at 12wks * List of enrolled patients kept in excel spreadsheet on encrypted department shared drive. Data points added alongside patient names until all data points collected for an individual patient, then identifying information removed and replaced with a study number which will be used to refer to their de-identified data set going forward. * Patients/caregivers would be responsible for obtainment and application of respective medications (both medications available over the counter for \< $15) * Primary and secondary outcomes will be assessed via Chi-square test

Conditions

• Molluscum Contagiosum

Interventions

Type	Name	Description
DRUG	Benzoyl peroxide	See arm description
DRUG	Adapalene Gel	See arm description

Timeline

• Start date: 2022-05-18
• Primary completion: 2023-10-09
• Completion: 2023-10-09
• First posted: 2022-09-13
• Last updated: 2024-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study