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Efficacy of Cantharidin in Molluscum Contagiosum

Primary Purpose

Molluscum Contagiosum, Skin Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cantharidin's vehicle
Cantharidin 0.7%
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molluscum Contagiosum, Skin Disease

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Anyone aged 5-10 years with the clinical diagnosis of molluscum contagiosum.

Exclusion Criteria:

  • Anyone with immunosuppression including HIV or previous organ transplantation.
  • Anyone taking immunosuppressive medications.
  • Anyone who has previously received treatment with cantharidin.
  • Any female who has had her first menstrual period.

Sites / Locations

  • University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

I

II

Arm Description

Subjects in this group will have topical application of cantharidin's vehicle at each visit.

Subjects in this group will have topical application of cantharidin at each visit.

Outcomes

Primary Outcome Measures

Patients Experiencing Complete Clearance of All Molluscum Lesions.

Secondary Outcome Measures

Mean Change in Each Group Measured by Lesion Count.
Average change in number of lesions from baseline to 8 weeks

Full Information

First Posted
April 24, 2008
Last Updated
June 16, 2011
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Center for Research Resources (NCRR), Doris Duke Charitable Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00667225
Brief Title
Efficacy of Cantharidin in Molluscum Contagiosum
Official Title
Efficacy of Cantharidin in Molluscum Contagiosum: A Randomized, Blinded, Placebo-Controlled Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Center for Research Resources (NCRR), Doris Duke Charitable Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The University of North Carolina Department of Dermatology is conducting a clinical trial to evaluate a drug called cantharidin in the treatment of molluscum contagiosum. Molluscum is a common dermatologic disorder caused by a poxvirus. Molluscum typically presents with many flesh-colored bumps on the skin. It goes away on its own, though can last several months to several years. Cantharidin is a topical medicine which is applied at the clinic visit. It is well tolerated by the majority of children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molluscum Contagiosum, Skin Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Placebo Comparator
Arm Description
Subjects in this group will have topical application of cantharidin's vehicle at each visit.
Arm Title
II
Arm Type
Experimental
Arm Description
Subjects in this group will have topical application of cantharidin at each visit.
Intervention Type
Drug
Intervention Name(s)
cantharidin's vehicle
Intervention Description
Cantharidin's vehicle is composed of: Hydroxypropylcellulose, Acetone, and Collodion Flexible. The vehicle will be topically applied to molluscum lesions at each visit. Only two lesions will be treated at the first visit, and up to 20 lesions can be treated at subsequent visits.
Intervention Type
Drug
Intervention Name(s)
Cantharidin 0.7%
Intervention Description
Subjects in this arm will receive cantharidin at all visits. At the first visit, up to 2 lesions can have application with cantharidin. All other visits will have up to 20 lesions with application of the cantharidin. During every visit, lesions will be counted and subjects will be assessed for any adverse events.
Primary Outcome Measure Information:
Title
Patients Experiencing Complete Clearance of All Molluscum Lesions.
Time Frame
Baseline compared to 8 weeks (5 visits)
Secondary Outcome Measure Information:
Title
Mean Change in Each Group Measured by Lesion Count.
Description
Average change in number of lesions from baseline to 8 weeks
Time Frame
Baseline compared to 8 weeks (5 visits)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anyone aged 5-10 years with the clinical diagnosis of molluscum contagiosum. Exclusion Criteria: Anyone with immunosuppression including HIV or previous organ transplantation. Anyone taking immunosuppressive medications. Anyone who has previously received treatment with cantharidin. Any female who has had her first menstrual period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacquelyn R Dosal, MD
Organizational Affiliation
UNC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Cantharidin in Molluscum Contagiosum

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