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WithdrawnNCT05536882Updated Mar 6, 2024

MC RCT - BPO vs Adapalene

A Phase 3 interventional study of Benzoyl peroxide and Adapalene Gel in Molluscum Contagiosum, sponsored by University of Oklahoma. Withdrawn at 1 site in United States. Open to participants aged 1 Year to 14 Years. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by University of Oklahoma · Phase 3, Interventional, and Treatment

Why this study was withdrawn
The original PI left the institution prior to final IRB approval and the remaining study team did not have the resources to continue.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2022, registered Sep 2022).
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
1 Year to 14 Years
Sex
All
01

Study 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.
Read the 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
02

Conditions studied

  • Molluscum Contagiosum

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Keywords

  • /drug ther
03

In context

Molluscum Contagiosum

22 studies on the registry are indexed under Molluscum Contagiosum; none are open to participants now.

Browse Molluscum Contagiosum studies →

Lead sponsor

University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    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

    Drug: Benzoyl peroxide

  • Active comparator
    Adapalene

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

    Drug: Adapalene Gel

Interventions

06

What researchers measure

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

    Time frame: 12 weeks

Secondary outcomes

  1. % change in lesion count at 12 weeks

    Time frame: 12 weeks

Other outcomes

  1. Incidence and severity of irritant contact dermatitis and other adverse events

    Time frame: 12 weeks

07

Study locations

1 site
  • OU Health Department of Dermatology
    Oklahoma City, Oklahoma 73104, United States
08

References and documents

Publications

  • 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.
  • Gupta, M. Adapalene in management of molluscum contagiosum in pediatric population. Our Dermatology Online. 2019, Vol. 10, 4, pp. 391-392.
  • 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.
  • Na G, et al. P074 Clinical experience of adapalene on molluscum contagiosum. 프로그램북(구 초록집). 2016;68(2):373-373.
  • 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. PubMed 18328209 ↗
  • 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. PubMed 22710541 ↗
  • Kim MS, Chun DK, Lee YS, et al. Treatment of Molluscum Contagiosum with Topical Tretinoin Therapy. Korean J Dermatol. 2001;39(6):666-670.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05536882
Lead sponsor
University of Oklahoma
Responsible party
Sponsor
First posted
Sep 13, 2022
Start date
May 18, 2022
Primary completion
Oct 9, 2023
Completion
Oct 9, 2023
Last update
Mar 6, 2024

Study contacts

Jason Hirshburg, MD
principal investigator · University of Oklahoma

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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