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

NCT ID: NCT02665260

Last Updated: 2017-05-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-01-31

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

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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).

Conditions

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Molluscum Contagiosum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cantharidin with occlusion

Cantharidin 0.7% topical with occlusion

Group Type ACTIVE_COMPARATOR

Cantharidin

Intervention Type DRUG

cantharidin 0.7% topical liquid

Gauze occlusion bandage

Intervention Type DEVICE

Gauze occlusion bandage with adhesive tape

Cantharidin without occlusion

Cantharidin 0.7% topical without occlusion

Group Type EXPERIMENTAL

Cantharidin

Intervention Type DRUG

cantharidin 0.7% topical liquid

Placebo with occlusion

Placebo topical with occlusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo topical liquid

Gauze occlusion bandage

Intervention Type DEVICE

Gauze occlusion bandage with adhesive tape

Placebo without occlusion

Placebo topical without occlusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo topical liquid

Interventions

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Cantharidin

cantharidin 0.7% topical liquid

Intervention Type DRUG

Placebo

Placebo topical liquid

Intervention Type DRUG

Gauze occlusion bandage

Gauze occlusion bandage with adhesive tape

Intervention Type DEVICE

Other Intervention Names

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2,6-Dimethyl-4,10-dioxatricyclo-decane-3,5-dione flexible collodion

Eligibility Criteria

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Inclusion Criteria

* 2-17years
* Healthy
* \<50 molluscum contagiosum lesions

Exclusion Criteria

* Immunosuppressed
* Oral corticosteroids
* Sexually active/pregnant
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Steven R Cohen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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12-01-004

Identifier Type: -

Identifier Source: org_study_id

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