MC RCT - BPO vs Adapalene

NCT ID: NCT05536882

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2023-10-09

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.

Detailed Description

• During the course of their normal workday, OU dermatology faculty and residents will be responsible for identifying and recruiting treatment-naïve patients being seen at the OU dermatology clinic for the diagnosis of molluscum contagiosum. These same faculty and residents will be responsible for approaching these patients regarding participation in the study. Chart review will not be a part of this selection process aside from what would naturally be done in the course of the patients' care. The same faculty and residents would be responsible for explaining the risks and benefits of study participation, obtaining written consent for study participation from a parent or guardian, obtaining verbal assent from patients aged 7-14 years old (as well as written assent for those capable of reading/writing), and randomizing patients to respective treatment wings using an online random number generator.
• # of MC lesions counted at time of recruitment, re-assessed at single follow up appointment at 12wks
• List of enrolled patients kept in excel spreadsheet on encrypted department shared drive. Data points added alongside patient names until all data points collected for an individual patient, then identifying information removed and replaced with a study number which will be used to refer to their de-identified data set going forward.
• Patients/caregivers would be responsible for obtainment and application of respective medications (both medications available over the counter for < $15)
• Primary and secondary outcomes will be assessed via Chi-square test

Conditions

Molluscum Contagiosum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Benzoyl peroxide

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

Group Type: EXPERIMENTAL

Benzoyl peroxide

Intervention Type: DRUG

See arm description

Adapalene

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

Group Type: ACTIVE_COMPARATOR

Adapalene Gel

Intervention Type: DRUG

See arm description

Interventions

Benzoyl peroxide

See arm description

Intervention Type: DRUG

Adapalene Gel

See arm description

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Hirshburg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

OU Health Department of Dermatology

Oklahoma City, Oklahoma, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 18328209 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22710541 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

IRB# 14663

Identifier Type: -

Identifier Source: org_study_id