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

Montefiore Medical Center94 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Molluscum Contagiosum

Interventions

CantharidinDRUG

cantharidin 0.7% topical liquid

PlaceboDRUG

Placebo topical liquid

Gauze occlusion bandageDEVICE

Gauze occlusion bandage with adhesive tape

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 6 weeks

Secondary Outcomes

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

Time frame: 33 weeks

Data from ClinicalTrials.gov

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