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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
  Purpose

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 Intervention
Molluscum Contagiosum, Skin Disease
 Drug: cantharidin's vehicle
Drug: Cantharidin 0.7%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Cantharidin in Molluscum Contagiosum: A Randomized, Blinded, Placebo-Controlled Prospective Study

Resource links provided by NLM:

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

Further study details as provided by University of North Carolina, Chapel Hill:

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

Secondary Outcome Measures:
  • 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


Enrollment: 29
Study Start Date: January 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 24, 2008
Results First Received: April 28, 2011
Last Updated: June 16, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013