MC RCT - BPO vs Adapalene

NCT05536882 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: IRB# 14663
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Molluscum Contagiosum

Keywords

/drug ther

Outcome Measures

Primary Outcomes (1)

• Complete clearance at 12 weeks

  Defined as lack of identifiable papular molluscum contagiosum lesions on physical exam at 12 week follow up visit

  12 weeks

Secondary Outcomes (1)

• % change in lesion count at 12 weeks

  12 weeks

Other Outcomes (1)

• Incidence and severity of irritant contact dermatitis and other adverse events

  12 weeks

Study Arms (2)

Benzoyl peroxide

EXPERIMENTAL

topical benzoyl peroxide 10% (vehicle choice per patient preference) applied 1-2x daily as tolerated until complete clearance or 12 week follow up

Drug: Benzoyl peroxide

Adapalene

ACTIVE COMPARATOR

adapalene 0.1% gel applied 1-2x daily as tolerated until complete clearance or 12 week follow up

Drug: Adapalene Gel

Interventions

Benzoyl peroxide DRUG

See arm description

Benzoyl peroxide

Adapalene Gel DRUG

See arm description

Adapalene

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

OU Health Department of Dermatology

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (7)

• Saryazdi, S. The Comparative Efficancy of Benzoyl Peroxide 10% Cream and Tretinoin 0.05% Cream In The Treatment of Molluscum Contagiosum. Pediatric Derm. 2004, Vol. 20, 3, p. 399.

  BACKGROUND

• Gupta, M. Adapalene in management of molluscum contagiosum in pediatric population. Our Dermatology Online. 2019, Vol. 10, 4, pp. 391-392.

  BACKGROUND

• Kashif M, Tahir R, Hussain I. Efficacy and safety of trichloroacetic acid 35% versus adapalene 0.1% in treatment of molluscum contagiosum in children. Journal of Pakistan Association of Dermatologists. 2016, Vol. 26, 4, pp. 366-370.

  BACKGROUND

• Na G, et al. P074 Clinical experience of adapalene on molluscum contagiosum. 프로그램북(구 초록집). 2016;68(2):373-373.

  BACKGROUND

• Scheinfeld N. Treatment of molluscum contagiosum: a brief review and discussion of a case successfully treated with adapelene. Dermatol Online J. 2007 Jul 13;13(3):15.

  PMID: 18328209 BACKGROUND

• Rajouria EA, Amatya A, Karn D. Comparative study of 5 % potassium hydroxide solution versus 0.05% tretinoin cream for Molluscum Contagiosum in children. Kathmandu Univ Med J (KUMJ). 2011 Oct-Dec;9(36):291-4. doi: 10.3126/kumj.v9i4.6347.

  PMID: 22710541 BACKGROUND

• Kim MS, Chun DK, Lee YS, et al. Treatment of Molluscum Contagiosum with Topical Tretinoin Therapy. Korean J Dermatol. 2001;39(6):666-670.

  BACKGROUND

MeSH Terms

Conditions

Molluscum Contagiosum

Interventions

Benzoyl Peroxide

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jason Hirshburg, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 13, 2022
• Study Start: May 18, 2022
• Primary Completion: October 9, 2023
• Study Completion: October 9, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)