Clinical Trial: Safety and Efficacy Study of Topical Cantharidin for the Treatment of Molluscum Contagiosum

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Pilot Study Investigating the Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum

Brief Summary: The purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids

Detailed Summary: This was a double-blind, placebo-controlled trial. Participants were recruited from the Pediatric Dermatology clinic at Montefiore Medical Center. One hundred eligible participants were randomly assigned to receive cantharidin 0.7% topical, cantharidin 0.7% topical with occlusion, placebo, or placebo with occlusion. Treatments were applied at weeks 0 and 3 (blinded phase). At week 6, all participants were treated with open-label, topical cantharidin 0.7% without occlusion every 3 weeks until all lesions resolved (open-label phase).
Sponsor: Montefiore Medical Center

Current Primary Outcome: Number of Subjects Who Achieve Complete Clearance at 6 Weeks [ Time Frame: 6 weeks ]

Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)


Original Primary Outcome: Percentage of subjects who achieve complete clearance at 6 weeks and 33 weeks [ Time Frame: 33 weeks ]

Assess percentage of subjects who achieve a lesion count of zero at 6 weeks (end of blinded phase) and 33 weeks (end of open-label phase)


Current Secondary Outcome: Number of Subjects Who Experienced an Adverse Event [ Time Frame: 33 weeks ]

Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit


Original Secondary Outcome: Frequency of adverse events [ Time Frame: 33 weeks ]

Assessed by patient-reported outcomes questionnaire at each visit


Information By: Montefiore Medical Center

Dates:
Date Received: December 31, 2015
Date Started: July 2012
Date Completion:
Last Updated: March 23, 2017
Last Verified: March 2017