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Completed

NCT Number: NCT02665260

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

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

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Key information

Conditions

Molluscum Contagiosum DNA Virus Infections Infections Poxviridae Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 2-17years
  • Healthy
  • <50 molluscum contagiosum lesions

Exclusion criteria

  • Immunosuppressed
  • Oral corticosteroids
  • Sexually active/pregnant

Treatment and study plan

Cantharidin

Drug

cantharidin 0.7% topical liquid

Other names: 2,6-Dimethyl-4,10-dioxatricyclo-decane-3,5-dione

Placebo

Drug

Placebo topical liquid

Other names: flexible collodion

Gauze occlusion bandage

Device

Gauze occlusion bandage with adhesive tape

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jan 27, 2016
Registry last updated
May 5, 2017

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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