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Efficacy of Cantharidin in Molluscum Contagiosum

This study has been completed.
Sponsor:
Collaborators:
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

April 24, 2008
June 16, 2011
January 2008
June 2009   (final data collection date for primary outcome measure)
Patients Experiencing Complete Clearance of All Molluscum Lesions. [ Time Frame: Baseline compared to 8 weeks (5 visits) ] [ Designated as safety issue: No ]
Complete Clearance of All Molluscum Lesions. [ Time Frame: 8 weeks, or 5 visits ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00667225 on ClinicalTrials.gov Archive Site
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
  • 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 ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Molluscum Contagiosum, Skin Disease
  • 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.
  • 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%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
June 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
5 Years to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00667225
IRB 07-1330, RR000046
No
Jacquelyn Coloe, Doris Duke Clinical Research Fellow, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • National Center for Research Resources (NCRR)
  • Doris Duke Charitable Foundation
Principal Investigator: Jacquelyn R Dosal, MD UNC
University of North Carolina, Chapel Hill
June 2011

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