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

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 2

Conditions: Molluscum Contagiosum

Treatments: Device: Gauze occlusion bandage; Drug: Placebo; Drug: Cantharidin

Study type: Interventional

Funder types: Other

Identifiers

NCT02665260

12-01-004

Details and patient eligibility

About

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

Full 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).

Enrollment: 94 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Immunosuppressed
• Oral corticosteroids
• Sexually active/pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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94 participants in 4 patient groups, including a placebo group

Cantharidin with occlusion

Active Comparator group

Description:

Cantharidin 0.7% topical with occlusion

Treatment:

Drug: Cantharidin

Device: Gauze occlusion bandage

Cantharidin without occlusion

Experimental group

Description:

Cantharidin 0.7% topical without occlusion

Treatment:

Drug: Cantharidin

Placebo with occlusion

Placebo Comparator group

Description:

Placebo topical with occlusion

Treatment:

Drug: Placebo

Device: Gauze occlusion bandage

Placebo without occlusion

Placebo Comparator group

Description:

Placebo topical without occlusion

Treatment:

Drug: Placebo