Efficacy of Cantharidin in Molluscum Contagiosum

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

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.

Study Overview

• Status: Completed
• Conditions: Molluscum Contagiosum, Skin Disease
• Intervention / Treatment: Drug: cantharidin's vehicle; Drug: Cantharidin 0.7%

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: I; Subjects in this group will have topical application of cantharidin's vehicle at each visit.	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.
Experimental: II; Subjects in this group will have topical application of cantharidin at each visit.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patients Experiencing Complete Clearance of All Molluscum Lesions.	Baseline compared to 8 weeks (5 visits)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Center for Research Resources (NCRR); Doris Duke Charitable Foundation
• Investigators: Principal Investigator: Jacquelyn R Dosal, MD, UNC

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: April 24, 2008
• First Submitted That Met QC Criteria: April 25, 2008
• First Posted (Estimate): April 28, 2008

Study Record Updates

• Last Update Posted (Estimate): June 21, 2011
• Last Update Submitted That Met QC Criteria: June 16, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Poxviridae Infections; Skin Diseases; Molluscum Contagiosum; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Cantharidin
• Other Study ID Numbers: IRB 07-1330; RR000046 (Other Grant/Funding Number: National Center for Research Resources (NCRR))