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MC RCT - BPO vs Adapalene

NCT05536882 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-03-06

No results posted yet for this study

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.

Conditions

  • Molluscum Contagiosum

Interventions

DRUG

Benzoyl peroxide

See arm description

DRUG

Adapalene Gel

See arm description

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Jason Hirshburg, MD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-18
Primary Completion
2023-10-09
Completion
2023-10-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05536882 on ClinicalTrials.gov