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Completed

NCT Number: NCT00667225

Efficacy of Cantharidin in Molluscum Contagiosum

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.

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Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cantharidin's vehicle

Drug

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.

Cantharidin 0.7%

Drug

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 outcomes

  1. Patients Experiencing Complete Clearance of All Molluscum Lesions.

    Time frame: Baseline compared to 8 weeks (5 visits)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 28, 2008
Registry last updated
Jun 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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