Efficacy of Cantharidin in Molluscum Contagiosum

Efficacy of Cantharidin in Molluscum Contagiosum: A Randomized, Blinded, Placebo-Controlled Prospective Study

Sponsors

Lead Sponsor: University of North Carolina, Chapel Hill

Collaborator: National Center for Research Resources (NCRR)
Doris Duke Charitable Foundation

Source University of North Carolina, Chapel Hill
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.

Overall Status Completed
Start Date 2008-01-01
Completion Date 2009-06-01
Primary Completion Date 2009-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Patients Experiencing Complete Clearance of All Molluscum Lesions. Baseline compared to 8 weeks (5 visits)
Secondary Outcome
Measure Time Frame
Mean Change in Each Group Measured by Lesion Count. Baseline compared to 8 weeks (5 visits)
Enrollment 29
Condition
Intervention

Intervention Type: Drug

Intervention Name: cantharidin's vehicle

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.

Arm Group Label: I

Intervention Type: Drug

Intervention Name: Cantharidin 0.7%

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.

Arm Group Label: II

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.

Gender:

All

Minimum Age:

5 Years

Maximum Age:

10 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jacquelyn R Dosal, MD Principal Investigator UNC
Location
Facility: University of North Carolina
Location Countries

United States

Verification Date

2011-06-01

Responsible Party

Name Title: Jacquelyn Coloe, Doris Duke Clinical Research Fellow

Organization: University of North Carolina, Chapel Hill

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: I

Type: Placebo Comparator

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

Label: II

Type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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