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

Phase 2

Completed

• Conditions: Molluscum Contagiosum
• Interventions: Drug: Cantharidin; Drug: Placebo; Device: Gauze occlusion bandage

• Registration Number: NCT02665260
• Lead Sponsor: Montefiore Medical Center

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2012-07
• Primary Completion: 2015-11
• Study First Submitted: 2015-12-31
• Study Completion: 2016-01
• Study First Submitted QC: 2016-01-22
• Study First Posted: 2016-01-27
• Results First Submitted: 2016-12-06
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-23
• Last Update Submitted: 2017-03-23
• Results First Posted: 2017-05-05
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• 2-17years
• Healthy
• <50 molluscum contagiosum lesions

Exclusion Criteria

• Immunosuppressed
• Oral corticosteroids
• Sexually active/pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cantharidin with occlusion	Gauze occlusion bandage	Cantharidin 0.7% topical with occlusion
Cantharidin without occlusion	Cantharidin	Cantharidin 0.7% topical without occlusion
Placebo with occlusion	Placebo	Placebo topical with occlusion
Placebo with occlusion	Gauze occlusion bandage	Placebo topical with occlusion
Placebo without occlusion	Placebo	Placebo topical without occlusion
Cantharidin with occlusion	Cantharidin	Cantharidin 0.7% topical with occlusion

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Who Experienced an Adverse Event	33 weeks	Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit