Efficacy of Cantharidin in Molluscum Contagiosum

Molluscum Contagiosum, Skin Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667225
• Other study ID #: IRB 07-1330
• Secondary ID: RR000046
• Status: Completed
• Phase: N/A
• First received: April 24, 2008
• Last updated: June 16, 2011
• Start date: January 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 10 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Molluscum Contagiosum
• Molluscum Contagiosum, Skin Disease
• Skin Diseases

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Experiencing Complete Clearance of All Molluscum Lesions.		Baseline compared to 8 weeks (5 visits)	No
Secondary	Mean Change in Each Group Measured by Lesion Count.	Average change in number of lesions from baseline to 8 weeks	Baseline compared to 8 weeks (5 visits)	No