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Retinoid
Benzoyl Peroxide vs Adapalene for Molluscum Contagiosum
Phase 3
Waitlist Available
Led By Jason Hirshburg, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing whether benzoyl peroxide or adapalene is more effective in treating molluscum contagiosum in children aged 1-14. The primary outcome is complete clearance at 12 weeks, and secondary outcomes include the percentage change in lesion count at 12 weeks.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Possible side effects include skin irritation, dryness, redness from benzoyl peroxide; adapalene may cause similar reactions plus sensitivity to sunlight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete clearance at 12 weeks
Secondary outcome measures
% change in lesion count at 12 weeks
Other outcome measures
Incidence and severity of irritant contact dermatitis and other adverse events
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benzoyl peroxide
2021
Completed Phase 4
~2840
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,610 Total Patients Enrolled
Jason Hirshburg, MDPrincipal InvestigatorUniversity of Oklahoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child, aged 1-14, has untreated molluscum contagiosum and we want treatment.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.I have been treated for molluscum contagiosum before.My caregiver does not speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Adapalene
- Group 2: Benzoyl peroxide
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which patients would be able to join this particular clinical study?
"This dermatology study is seeking to recruit 150 young patients, aged 1-14 years old, that have not received prior treatment for molluscum contagiosum. To be eligible, children must be seen in an OU Dermatology resident or faculty clinic and must have a parent or guardian that desires treatment."
Answered by AI
Has the FDA sanctioned Benzoyl peroxide for therapeutic use?
"Benzoyl peroxide's safety is well documented, with multiple clinical trials and Phase 3 studies backing its efficacy."
Answered by AI
Does this research involve participants who are over 35 years old?
"This particular trial is only taking patients that are aged 1 year to 14. However, there are 3 other clinical trials for people who are younger and 1 for people who are older."
Answered by AI
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