MC RCT - BPO vs Adapalene

March 4, 2024 updated by: University of Oklahoma

Randomized Controlled Trial Comparing the Efficacy of Adapalene 0.1% Gel to 10% Benzoyl Peroxide in Treating Molluscum Contagiosum.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 14 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
See arm description
Active Comparator: Adapalene
adapalene 0.1% gel applied 1-2x daily as tolerated until complete clearance or 12 week follow up
Drug: Adapalene Gel
See arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete clearance at 12 weeks
Time Frame: 12 weeks
Defined as lack of identifiable papular molluscum contagiosum lesions on physical exam at 12 week follow up visit
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
% change in lesion count at 12 weeks
Time Frame: 12 weeks
12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of irritant contact dermatitis and other adverse events
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Jason Hirshburg, MD, University of Oklahoma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2022

Primary Completion (Actual)

October 9, 2023

Study Completion (Actual)

October 9, 2023

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 14663

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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