Benzoyl Peroxide vs Adapalene for Molluscum Contagiosum

Overseen By Chance Morris, MD

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Oklahoma

Must not be taking: Topical retinoids, Benzoyl peroxide

Disqualifiers: Prior treatment, Pregnancy, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two topical treatments, benzoyl peroxide and adapalene gel, to determine which more effectively clears molluscum contagiosum, a skin condition that causes small, raised bumps. Participants will apply either benzoyl peroxide or adapalene gel to the skin to evaluate how well these treatments clear the bumps after 12 weeks. The trial is open to children aged 1 to 14 who have molluscum contagiosum and have not yet received treatment for it. As a Phase 3 trial, this research represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that adapalene can cause side effects such as redness, dryness, itching, and burning. However, it is considered safer than some other treatments and is often the first choice for treating molluscum contagiosum, especially when other treatments prove ineffective.

Benzoyl peroxide kills germs and dries out skin bumps. It is generally safe, but it can bleach clothes, so wearing a white shirt overnight is advisable.

Researchers are studying both treatments because they are usually well-tolerated. While they might cause mild skin irritation, both are considered safe options for children with molluscum contagiosum. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for molluscum contagiosum because they offer a fresh take on managing this common skin condition. Unlike the standard options like cryotherapy or curettage, adapalene gel, known for treating acne, is being repurposed to tackle molluscum, potentially reducing lesions by promoting skin cell turnover. On the other hand, benzoyl peroxide, a familiar acne fighter, is being tested for its antimicrobial properties to help clear the viral infection efficiently. Both treatments stand out for their ease of use as topical applications, possibly offering a less invasive and more convenient alternative to current methods.

What evidence suggests that this trial's treatments could be effective for molluscum contagiosum?

This trial will compare the effectiveness of Adapalene Gel and Benzoyl Peroxide in treating molluscum contagiosum. Research has shown that Adapalene 0.1% gel, used by participants in one arm of this trial, may effectively treat molluscum contagiosum. Some patients have experienced clearer skin, suggesting its potential efficacy. Adapalene, a topical retinoid, helps skin cells renew faster and can reduce skin bumps.

Participants in another arm of this trial will use Benzoyl Peroxide 10%, which might improve skin conditions in the short term. It fights bacteria and reduces swelling, potentially helping with skin bumps like those from molluscum contagiosum. However, less research exists on Benzoyl Peroxide specifically for molluscum contagiosum compared to Adapalene. Both treatments might help, but Adapalene has stronger evidence supporting its use for this condition. ^{2 3 6 7 8}

Who Is on the Research Team?

Jason Hirshburg, MD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Adapalene Gel
• Benzoyl peroxide

Trial Overview 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.

How Is the Trial Designed?

Group I: Benzoyl peroxide Experimental Treatment 1 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: Adapalene Active Control 1 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

Approved in European Union as Differin for:

• Acne vulgaris
• Seborrhoeic keratoses

Approved in Canada as Differin for:

• Acne vulgaris

Approved in Japan as Differin for:

• Acne vulgaris

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8807962/

Topical adapalene for the treatment of follicular conjunctivitis ... We report two cases of periocular molluscum contagiosum successfully treated with topical adapalene 0.1% gel, a commercially available third-generation ...

2. opendermatologyjournal.com opendermatologyjournal.com/VOLUME/18/ELOCATOR/e18743722340545/PDF/

Evaluating the Role of Topical Immunomodulators for ... Objective: This review aimed to evaluate topical immunomodulators for the treatment of molluscum contagiosum, focusing on their mechanisms, ...

3. jpad.com.pk jpad.com.pk/index.php/jpad/article/download/1914/1741

Efficacy and safety of adapalene 0.1 % vs. trichloroacetic ... 12 TCA is 90% effective for treatment of molluscum contagiosum. 13 Nevertheless it is irritant and cause pain. Adapalene is a topical retinoid of third ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9674806/

New Developing Treatments for Molluscum Contagiosum - PMC Complete clearance was observed after 3 months in 50% of patients treated with VP-102 and 32% of patients treated with SB206, and in both studies a significant ...

5. sciencedirect.com sciencedirect.com/org/science/article/pii/S1874372224000130

Evaluating the Role of Topical Immunomodulators for ... This review aimed to evaluate topical immunomodulators for the treatment of molluscum contagiosum, focusing on their mechanisms, administration methods, ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482509/

Adapalene - StatPearls - NCBI Bookshelf - NIH Adverse reactions reported from adapalene include photosensitivity, irritation, redness, dryness, itching, and burning. · Adapalene is less irritating compared ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2451993622000810

Topical adapalene for the treatment of follicular ... As such, our results are promising that the use of adapalene may be a safe and effective option for treating periocular molluscum contagiosum and any associated ...

8. odermatol.com odermatol.com/odermatology/20194/22.Adapalene-GuptaM.pdf

Adapalene in management of molluscum contagiosum in ... A few studies have demonstrated the efficacy and safety of adapalene 0.1% gel in the management of molluscum in children [5].