Molluscum ContagiosumPhase 3NCT05536882
MC RCT - BPO vs Adapalene
A Phase 3 study testing Benzoyl peroxide and Adapalene Gel in people with Molluscum Contagiosum, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Molluscum Contagiosum
- What is being tested?
- Benzoyl peroxide and Adapalene Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 9 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
OU Health Department of Dermatology
Oklahoma City, Oklahoma, 73104
About this study
Official title: 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.
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
- Conditions
- Molluscum Contagiosum
- Being tested
- Benzoyl peroxide, Adapalene Gel
- Keywords
- /drug ther
- Medical subject headings
- Molluscum Contagiosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzoyl peroxideDrug
See arm description
Adapalene GelDrug
See arm description
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Benzoyl peroxide |
| Adapalene | Active comparator | adapalene 0.1% gel applied 1-2x daily as tolerated until complete clearance or 12 week follow up Receives: Drug: Adapalene Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clearance at 12 weeks
Defined as lack of identifiable papular molluscum contagiosum lesions on physical exam at 12 week follow up visit
Measured: 12 weeks
Secondary outcomes (1)
% change in lesion count at 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start18 May 2022
- Primary completion9 Oct 2023
- Study completion9 Oct 2023
Why it stopped: The original PI left the institution prior to final IRB approval and the remaining study team did not have the resources to continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Molluscum ContagiosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Hirshburg, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536882
- Sponsor's protocol ID
- IRB# 14663
- Status last verified
- Mar 2024
- First submitted
- 7 Sep 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 18328209Rajouria 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 22710541Kim MS, Chun DK, Lee YS, et al. Treatment of Molluscum Contagiosum with Topical Tretinoin Therapy. Korean J Dermatol. 2001;39(6):666-670.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Efficacy of Adapalene 0.1% Gel to 10% Benzoyl Peroxide in Treating Molluscum Contagiosum.
- ClinicalTrials.gov ID
- NCT05536882
- Acronym / sponsor ID
- IRB# 14663
- Conditions
- Molluscum Contagiosum
- Keywords
- /drug ther
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The original PI left the institution prior to final IRB approval and the remaining study team did not have the resources to continue.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benzoyl peroxide | Experimental | Drug: Benzoyl peroxidetopical benzoyl peroxide 10% (vehicle choice per patient preference) applied 1-2x daily as tolerated until complete clearance or 12 week follow up |
| Adapalene | Active comparator | Drug: Adapalene Geladapalene 0.1% gel applied 1-2x daily as tolerated until complete clearance or 12 week follow up |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benzoyl peroxideSee arm description | Drug | Benzoyl peroxide |
| Adapalene GelSee arm description | Drug | Adapalene |
Primary outcome
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
1 secondary outcome
% change in lesion count at 12 weeks
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- BackgroundSaryazdi, 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.
- BackgroundGupta, M. Adapalene in management of molluscum contagiosum in pediatric population. Our Dermatology Online. 2019, Vol. 10, 4, pp. 391-392.
- BackgroundKashif 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.
- BackgroundNa G, et al. P074 Clinical experience of adapalene on molluscum contagiosum. 프로그램북(구 초록집). 2016;68(2):373-373.
- Background: PubMed 18328209Scheinfeld 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.
- Background: PubMed 22710541Rajouria 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.
- BackgroundKim 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 dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Hirshburg, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benzoyl peroxide and Adapalene Gel in people with Molluscum Contagiosum, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clearance at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05536882, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.