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Benzoyl Peroxide vs Adapalene for Molluscum Contagiosum

CM
Overseen ByChance Morris, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests two treatments for children with molluscum contagiosum. One treatment uses benzoyl peroxide to kill germs and dry out bumps. The other uses adapalene to reduce swelling and prevent new bumps. The goal is to see which treatment clears the skin better over a few months.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the trial coordinators or your doctor.

How does the drug Adapalene Gel, Benzoyl Peroxide differ from other treatments for molluscum contagiosum?

Adapalene Gel and Benzoyl Peroxide are typically used for acne treatment, and their use for molluscum contagiosum is novel as there are no standard treatments for this condition. This combination may offer a new approach by utilizing their known effects on skin lesions.12345

Research Team

JH

Jason Hirshburg, MD

Principal Investigator

University of Oklahoma

Eligibility Criteria

This trial is for children aged 1 to 14 with molluscum contagiosum who haven't been treated before. It's open to those whose parents want treatment and can consent, but not for kids who've had reactions to topical retinoids or benzoyl peroxide, among others.

Inclusion Criteria

My child, aged 1-14, has untreated molluscum contagiosum and we want treatment.

Exclusion Criteria

I do not agree to participate in this study.
You have had a bad reaction to any skin products containing retinoids, benzoyl peroxide, cinnamon, or similar ingredients like salicylic acid or hydroquinone.
Pregnant females.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either adapalene 0.1% gel or benzoyl peroxide 10% applied 1-2 times daily as tolerated

12 weeks
1 visit (in-person) at 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Adapalene Gel
  • Benzoyl peroxide
Trial OverviewThe study compares the effectiveness of two creams: benzoyl peroxide (10%) and adapalene gel (0.1%) in treating molluscum contagiosum. Kids will use one of these treatments daily as tolerated, aiming for complete lesion clearance at 12 weeks.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Benzoyl peroxideExperimental Treatment1 Intervention
topical benzoyl peroxide 10% (vehicle choice per patient preference) applied 1-2x daily as tolerated until complete clearance or 12 week follow up
Group II: AdapaleneActive Control1 Intervention
adapalene 0.1% gel applied 1-2x daily as tolerated until complete clearance or 12 week follow up

Adapalene Gel is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Differin for:
  • Acne vulgaris
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Approved in European Union as Differin for:
  • Acne vulgaris
  • Seborrhoeic keratoses
🇨🇦
Approved in Canada as Differin for:
  • Acne vulgaris
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Approved in Japan as Differin for:
  • Acne vulgaris

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

References

Benzoyl peroxide, adapalene, and their combination in the treatment of acne vulgaris. [2019]
The efficacy, safety and tolerability of adapalene versus benzoyl peroxide in the treatment of mild acne vulgaris; a randomized trial. [2015]
Single-blind and comparative clinical study of the efficacy and safety of benzoyl peroxide 4% gel (BID) and adapalene 0.1% Gel (QD) in the treatment of acne vulgaris for 11 weeks. [2019]
A North American study of adapalene-benzoyl peroxide combination gel in the treatment of acne. [2015]
The efficacy, safety, and tolerability of adapalene versus benzoyl peroxide in the treatment of mild acne vulgaris: a randomized trial. [2015]