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

Molluscum Contagiosum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665260
• Other study ID #: 12-01-004
• Status: Completed
• Phase: Phase 2
• First received: December 31, 2015
• Last updated: January 22, 2016
• Start date: July 2012
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• 2-17years

• Healthy

• <50 molluscum contagiosum lesions

Exclusion Criteria:

• Immunosuppressed

• Oral corticosteroids

• Sexually active/pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Molluscum Contagiosum

Intervention

Drug:
• Cantharidin
cantharidin 0.7% topical liquid
• Placebo
Placebo topical liquid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects who achieve complete clearance at 6 weeks and 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)	33 weeks	No
Secondary	Frequency of adverse events	Assessed by patient-reported outcomes questionnaire at each visit	33 weeks	No