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| Sponsors and Collaborators: |
The University of North Carolina, Chapel Hill National Center for Research Resources (NCRR) Doris Duke Charitable Foundation |
|---|---|
| Information provided by: | The University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00667225 |
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 |
|---|---|
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Molluscum Contagiosum, Skin Disease |
Drug: cantharidin's vehicle Drug: Cantharidin 0.7% |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Efficacy of Cantharidin in Molluscum Contagiosum: A Randomized, Blinded, Placebo-Controlled Prospective Study |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
I: Placebo Comparator
Subjects in this group will have topical application of cantharidin's vehicle at each visit.
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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.
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II: Experimental
Subjects in this group will have topical application of cantharidin at each visit.
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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.
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Eligibility| Ages Eligible for Study: | 5 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jacquelyn R Coloe, BS | 631-678-8537 | jcoloe@med.unc.edu |
| Contact: Dean S Morrell, MD | 919-966-0785 | morrell@med.unc.edu |
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27514 | |
| Contact: Jacquelyn R Coloe 919-966-1647 jcoloe@med.unc.edu | |
| Principal Investigator: Jacquelyn R Coloe | |
| Principal Investigator: | Jacquelyn R Coloe, BS | UNC |
More Information
| Responsible Party: | University of North Carolina, Chapel Hill ( Jacquelyn Coloe, Doris Duke Clinical Research Fellow ) |
| Study ID Numbers: | IRB 07-1330, GCRC-2648, RR000046 |
| Study First Received: | April 24, 2008 |
| Last Updated: | March 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00667225 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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Virus Diseases Cantharidin Skin Diseases, Infectious Poxviridae Infections |
Skin Diseases Molluscum Contagiosum DNA Virus Infections |
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Skin Diseases, Viral Virus Diseases Cantharidin Skin Diseases, Infectious Molecular Mechanisms of Pharmacological Action Poxviridae Infections |
Skin Diseases Molluscum Contagiosum Enzyme Inhibitors DNA Virus Infections Pharmacologic Actions |
