Efficacy of Cantharidin in Molluscum Contagiosum

This study has been completed.

Sponsor:

Collaborators:

National Center for Research Resources (NCRR)

Doris Duke Charitable Foundation

Information provided by:

University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT00667225

First received: April 24, 2008

Last updated: June 16, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 24, 2008

Last Updated Date

June 16, 2011

Start Date ^ICMJE

January 2008

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Patients Experiencing Complete Clearance of All Molluscum Lesions. [ Time Frame: Baseline compared to 8 weeks (5 visits) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Complete Clearance of All Molluscum Lesions. [ Time Frame: 8 weeks, or 5 visits ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00667225 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Mean Change in Each Group Measured by Lesion Count. [ Time Frame: Baseline compared to 8 weeks (5 visits) ] [ Designated as safety issue: No ]

Average change in number of lesions from baseline to 8 weeks

Original Secondary Outcome Measures ^ICMJE

Partial clearance of molluscum lesions. [ Time Frame: 8 weeks or 5 visits ] [ Designated as safety issue: No ]
Association of clinical course with presence of atopic dermatitis. [ Time Frame: 8 weeks or 5 visits ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy of Cantharidin in Molluscum Contagiosum

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Molluscum Contagiosum, Skin Disease

Intervention ^ICMJE

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.
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.

Study Arm (s)

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

Intervention: Drug: cantharidin's vehicle
Experimental: II
Subjects in this group will have topical application of cantharidin at each visit.

Intervention: Drug: Cantharidin 0.7%

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

5 Years to 10 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00667225

Other Study ID Numbers ^ICMJE

IRB 07-1330, RR000046

Has Data Monitoring Committee

Responsible Party

Jacquelyn Coloe, Doris Duke Clinical Research Fellow, University of North Carolina, Chapel Hill

Study Sponsor ^ICMJE

University of North Carolina, Chapel Hill

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Jacquelyn R Dosal, MD

UNC

Information Provided By

University of North Carolina, Chapel Hill

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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