MC RCT - BPO vs Adapalene

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Treatments: Adapalene; Benzoyl Peroxide

Criteria

Inclusion Criteria:

• Children aged 1 year to 14 years old seen in an OU Dermatology resident or faculty clinic and diagnosed with molluscum contagiosum who have not received prior treatment for this condition, and whose parent/guardian(s) desire treatment for this condition.

Exclusion Criteria:

• Patients who have received prior treatment for molluscum contagiosum.

• Patients with a history of adverse reaction to any topical retinoid, benzoyl peroxide, cinnamon, or other benzoic derivatives (e.g., salicylic acid, hydroquinone, catechol, vanillin).

• Pregnant females.

• Patients with caregivers who do not speak English.

• Patients with caregivers who are unable to provide consent.

• Patients who decline to assent for participation.