Safety and Efficacy Study of Topical Cantharidin for the Treatment of Molluscum Contagiosum

Study Overview
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Brief Summary
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The purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids

Detailed Description
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This was a double-blind, placebo-controlled trial. Participants were recruited from the Pediatric Dermatology clinic at Montefiore Medical Center. One hundred eligible participants were randomly assigned to receive cantharidin 0.7% topical, cantharidin 0.7% topical with occlusion, placebo, or placebo with occlusion. Treatments were applied at weeks 0 and 3 (blinded phase). At week 6, all participants were treated with open-label, topical cantharidin 0.7% without occlusion every 3 weeks until all lesions resolved (open-label phase).

Official Title
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Randomized Pilot Study Investigating the Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum

Conditions
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Molluscum Contagiosum

Intervention / Treatment
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* Drug: Cantharidin
* Drug: Placebo
* Device: Gauze occlusion bandage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 2-17years Healthy <50 molluscum contagiosum lesions Exclusion Criteria: Immunosuppressed Oral corticosteroids Sexually active/pregnant

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cantharidin with occlusion<br>Cantharidin 0.7% topical with occlusion | Drug: Cantharidin<br>* cantharidin 0.7% topical liquid<br>* Other names: 2,6-Dimethyl-4,10-dioxatricyclo-decane-3,5-dione;Device: Gauze occlusion bandage<br>* Gauze occlusion bandage with adhesive tape<br>|
| Experimental: Cantharidin without occlusion<br>Cantharidin 0.7% topical without occlusion | Drug: Cantharidin<br>* cantharidin 0.7% topical liquid<br>* Other names: 2,6-Dimethyl-4,10-dioxatricyclo-decane-3,5-dione;|
| Placebo Comparator: Placebo with occlusion<br>Placebo topical with occlusion | Drug: Placebo<br>* Placebo topical liquid<br>* Other names: flexible collodion;Device: Gauze occlusion bandage<br>* Gauze occlusion bandage with adhesive tape<br>|
| Placebo Comparator: Placebo without occlusion<br>Placebo topical without occlusion | Drug: Placebo<br>* Placebo topical liquid<br>* Other names: flexible collodion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Achieve Complete Clearance at 6 Weeks | Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Experienced an Adverse Event | Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit | 33 weeks |