MC RCT - BPO vs Adapalene

University of Oklahoma (OU)

Status and phase: Withdrawn; Phase 3

Conditions: Molluscum Contagiosum

Treatments: Drug: Adapalene Gel; Drug: Benzoyl peroxide

Study type: Interventional

Funder types: Other

Identifiers

NCT05536882

IRB# 14663

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 1 to 14 years old

Volunteers: No 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.

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 1 to 14 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Benzoyl peroxide

Experimental group

Description:

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

Treatment:

Drug: Benzoyl peroxide

Adapalene

Active Comparator group

Description:

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

Treatment:

Drug: Adapalene Gel