What side effects are associated with this type of intervention?

Benzoyl Peroxide, commonly used for Molluscum Contagiosum, can cause skin dryness, redness, peeling, and irritation, and may bleach hair or fabrics. Adapalene, another common treatment, often leads to skin irritation, dryness, redness, and scaling, especially in the initial weeks. Both treatments can increase skin sensitivity to sunlight, so sunscreen use is recommended.

What prior FDA approvals exist?

There is limited information on specific FDA approvals for the treatment of Molluscum Contagiosum using benzoyl peroxide or adapalene. However, benzoyl peroxide, an antimicrobial and keratolytic agent, and adapalene, a retinoid, are commonly used in dermatology for their efficacy in treating various skin conditions. Benzoyl peroxide is known for its antibacterial properties and ability to promote skin peeling, while adapalene helps in modulating skin cell turnover. These properties make them potential candidates for treating Molluscum Contagiosum, as indicated by ongoing studies comparing their effectiveness.

What other types of research exist?

Promising novel alternatives for treating Molluscum Contagiosum in 2024 include topical therapies such as Imiquimod, which is an immune response modifier, and Cidofovir, an antiviral agent. Additionally, light-based therapies like photodynamic therapy (PDT) using 5-aminolevulinic acid (ALA) have shown potential. These treatments offer different mechanisms of action compared to traditional antimicrobials and retinoids, potentially providing effective options for patients.

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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

Must not have

Patients who decline to assent for participation.

Patients who have received prior treatment for molluscum contagiosum.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not agree to participate in this study.

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I have been treated for molluscum contagiosum before.

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My caregiver does not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete clearance at 12 weeks

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Benzoyl Peroxide works by reducing bacterial load and promoting the shedding of the outer skin layer, which helps in clearing Molluscum Contagiosum lesions. Adapalene, a retinoid, modulates cell differentiation and keratinization, normalizing skin cell turnover and reducing lesion formation. These mechanisms are crucial for patients as they explain how these treatments help manage and clear the infection effectively.

Treatment of molluscum contagiosum in males with an analog of imiquimod 1% in cream: a placebo-controlled, double-blind study.[Molluscum contagiosum: treatment with pulsed dye laser].