Efficacy of Cantharidin in Molluscum Contagiosum

Study Overview
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Brief Summary
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The University of North Carolina Department of Dermatology is conducting a clinical trial to evaluate a drug called cantharidin in the treatment of molluscum contagiosum. Molluscum is a common dermatologic disorder caused by a poxvirus. Molluscum typically presents with many flesh-colored bumps on the skin. It goes away on its own, though can last several months to several years. Cantharidin is a topical medicine which is applied at the clinic visit. It is well tolerated by the majority of children.

Official Title
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Efficacy of Cantharidin in Molluscum Contagiosum: A Randomized, Blinded, Placebo-Controlled Prospective Study

Conditions
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Molluscum Contagiosum, Skin Disease

Intervention / Treatment
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* Drug: cantharidin's vehicle
* Drug: Cantharidin 0.7%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anyone aged 5-10 years with the clinical diagnosis of molluscum contagiosum. Exclusion Criteria: Anyone with immunosuppression including HIV or previous organ transplantation. Anyone taking immunosuppressive medications. Anyone who has previously received treatment with cantharidin. Any female who has had her first menstrual period.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: I<br>Subjects in this group will have topical application of cantharidin's vehicle at each visit. | Drug: cantharidin's vehicle<br>* Cantharidin's vehicle is composed of: Hydroxypropylcellulose, Acetone, and Collodion Flexible. The vehicle will be topically applied to molluscum lesions at each visit. Only two lesions will be treated at the first visit, and up to 20 lesions can be treated at subsequent visits.<br>|
| Experimental: II<br>Subjects in this group will have topical application of cantharidin at each visit. | Drug: Cantharidin 0.7%<br>* Subjects in this arm will receive cantharidin at all visits. At the first visit, up to 2 lesions can have application with cantharidin. All other visits will have up to 20 lesions with application of the cantharidin. During every visit, lesions will be counted and subjects will be assessed for any adverse events.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Experiencing Complete Clearance of All Molluscum Lesions. |  | Baseline compared to 8 weeks (5 visits) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Each Group Measured by Lesion Count. | Average change in number of lesions from baseline to 8 weeks | Baseline compared to 8 weeks (5 visits) |