Efficacy of Cantharidin in Molluscum Contagiosum

NCT ID: NCT00667225

Last Updated: 2011-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-06-30

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.

Conditions

Molluscum Contagiosum, Skin Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

I

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

Group Type: PLACEBO_COMPARATOR

cantharidin's vehicle

Intervention Type: DRUG

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.

II

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

Group Type: EXPERIMENTAL

Cantharidin 0.7%

Intervention Type: DRUG

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.

Interventions

cantharidin's vehicle

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

Cantharidin 0.7%

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

Doris Duke Charitable Foundation

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

University of North Carolina, Chapel Hill

Principal Investigators

Jacquelyn R Dosal, MD

Role: PRINCIPAL_INVESTIGATOR

UNC

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

RR000046

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB 07-1330

Identifier Type: -

Identifier Source: org_study_id