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Efficacy of Cantharidin in Molluscum Contagiosum

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ClinicalTrials.gov Identifier: NCT00667225
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : June 1, 2011
Last Update Posted : June 21, 2011
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
Doris Duke Charitable Foundation
Information provided by:
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Molluscum Contagiosum, Skin Disease Drug: cantharidin's vehicle Drug: Cantharidin 0.7% Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Cantharidin in Molluscum Contagiosum: A Randomized, Blinded, Placebo-Controlled Prospective Study
Study Start Date : January 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Patients Experiencing Complete Clearance of All Molluscum Lesions. [ Time Frame: Baseline compared to 8 weeks (5 visits) ]

Secondary Outcome Measures :
  1. Mean Change in Each Group Measured by Lesion Count. [ Time Frame: Baseline compared to 8 weeks (5 visits) ]
    Average change in number of lesions from baseline to 8 weeks



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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667225


Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Center for Research Resources (NCRR)
Doris Duke Charitable Foundation
Investigators
Principal Investigator: Jacquelyn R Dosal, MD UNC

Responsible Party: Jacquelyn Coloe, Doris Duke Clinical Research Fellow, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00667225     History of Changes
Other Study ID Numbers: IRB 07-1330
RR000046 ( Other Grant/Funding Number: National Center for Research Resources (NCRR) )
First Posted: April 28, 2008    Key Record Dates
Results First Posted: June 1, 2011
Last Update Posted: June 21, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Skin Diseases
Molluscum Contagiosum
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Cantharidin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action