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MC RCT - BPO vs Adapalene

Primary Purpose

Molluscum Contagiosum

Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Benzoyl peroxide
Adapalene Gel
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molluscum Contagiosum focused on measuring /drug ther

Eligibility Criteria

1 Year - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • OU Health Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Benzoyl peroxide

Adapalene

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

% change in lesion count at 12 weeks

Full Information

First Posted
September 7, 2022
Last Updated
September 7, 2022
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT05536882
Brief Title
MC RCT - BPO vs Adapalene
Official Title
Randomized Controlled Trial Comparing the Efficacy of Adapalene 0.1% Gel to 10% Benzoyl Peroxide in Treating Molluscum Contagiosum.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molluscum Contagiosum
Keywords
/drug ther

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Benzoyl peroxide
Arm Type
Experimental
Arm Description
topical benzoyl peroxide 10% (vehicle choice per patient preference) applied 1-2x daily as tolerated until complete clearance or 12 week follow up
Arm Title
Adapalene
Arm Type
Active Comparator
Arm Description
adapalene 0.1% gel applied 1-2x daily as tolerated until complete clearance or 12 week follow up
Intervention Type
Drug
Intervention Name(s)
Benzoyl peroxide
Intervention Description
See arm description
Intervention Type
Drug
Intervention Name(s)
Adapalene Gel
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
Complete clearance at 12 weeks
Description
Defined as lack of identifiable papular molluscum contagiosum lesions on physical exam at 12 week follow up visit
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
% change in lesion count at 12 weeks
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Incidence and severity of irritant contact dermatitis and other adverse events
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chance Morris, MD
Phone
918-282-8031
Email
chance-morris@ouhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Hirshburg, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
OU Health Department of Dermatology
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renee Wall
Phone
405-271-6110
Email
renee-wall@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Jason Hirshburg, MD
Phone
4052716110
Email
jason-hirshburg@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Pamela Allen, MD
First Name & Middle Initial & Last Name & Degree
Chance Morris, MD
First Name & Middle Initial & Last Name & Degree
Paul Pitts
First Name & Middle Initial & Last Name & Degree
Jarad Levin, MD
First Name & Middle Initial & Last Name & Degree
Jeffrey McBride, MD
First Name & Middle Initial & Last Name & Degree
Franzetti Michael, MD
First Name & Middle Initial & Last Name & Degree
Jason Hirshburg, MD
First Name & Middle Initial & Last Name & Degree
Aaminah Azhar, MD
First Name & Middle Initial & Last Name & Degree
Joshua Brady, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
Citation
Gupta, M. Adapalene in management of molluscum contagiosum in pediatric population. Our Dermatology Online. 2019, Vol. 10, 4, pp. 391-392.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Na G, et al. P074 Clinical experience of adapalene on molluscum contagiosum. 프로그램북(구 초록집). 2016;68(2):373-373.
Results Reference
background
PubMed Identifier
18328209
Citation
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.
Results Reference
background
PubMed Identifier
22710541
Citation
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.
Results Reference
background
Citation
Kim MS, Chun DK, Lee YS, et al. Treatment of Molluscum Contagiosum with Topical Tretinoin Therapy. Korean J Dermatol. 2001;39(6):666-670.
Results Reference
background

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MC RCT - BPO vs Adapalene

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