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

March 23, 2017 updated by: Steven R Cohen, Montefiore Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Immunosuppressed
  • Oral corticosteroids
  • Sexually active/pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cantharidin with occlusion
Cantharidin 0.7% topical with occlusion
Drug: Cantharidin
cantharidin 0.7% topical liquid
Other Names:
  • 2,6-Dimethyl-4,10-dioxatricyclo-decane-3,5-dione
Device: Gauze occlusion bandage
Gauze occlusion bandage with adhesive tape
Experimental: Cantharidin without occlusion
Cantharidin 0.7% topical without occlusion
Drug: Cantharidin
cantharidin 0.7% topical liquid
Other Names:
  • 2,6-Dimethyl-4,10-dioxatricyclo-decane-3,5-dione
Placebo Comparator: Placebo with occlusion
Placebo topical with occlusion
Device: Gauze occlusion bandage
Gauze occlusion bandage with adhesive tape
Drug: Placebo
Placebo topical liquid
Other Names:
  • flexible collodion
Placebo Comparator: Placebo without occlusion
Placebo topical without occlusion
Drug: Placebo
Placebo topical liquid
Other Names:
  • flexible collodion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Experienced an Adverse Event
Time Frame: 33 weeks
Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit
33 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

December 31, 2015

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-01-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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