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

Primary Purpose

Molluscum Contagiosum

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cantharidin
Placebo
Gauze occlusion bandage
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molluscum Contagiosum

Eligibility Criteria

2 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Immunosuppressed
  • Oral corticosteroids
  • Sexually active/pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Placebo Comparator

    Placebo Comparator

    Arm Label

    Cantharidin with occlusion

    Cantharidin without occlusion

    Placebo with occlusion

    Placebo without occlusion

    Arm Description

    Cantharidin 0.7% topical with occlusion

    Cantharidin 0.7% topical without occlusion

    Placebo topical with occlusion

    Placebo topical without occlusion

    Outcomes

    Primary Outcome Measures

    Number of Subjects Who Achieve Complete Clearance at 6 Weeks
    Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)

    Secondary Outcome Measures

    Number of Subjects Who Experienced an Adverse Event
    Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit

    Full Information

    First Posted
    December 31, 2015
    Last Updated
    March 23, 2017
    Sponsor
    Montefiore Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02665260
    Brief Title
    Safety and Efficacy Study of Topical Cantharidin for the Treatment of Molluscum Contagiosum
    Official Title
    Randomized Pilot Study Investigating the Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2012 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Montefiore Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Molluscum Contagiosum

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    94 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cantharidin with occlusion
    Arm Type
    Active Comparator
    Arm Description
    Cantharidin 0.7% topical with occlusion
    Arm Title
    Cantharidin without occlusion
    Arm Type
    Experimental
    Arm Description
    Cantharidin 0.7% topical without occlusion
    Arm Title
    Placebo with occlusion
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo topical with occlusion
    Arm Title
    Placebo without occlusion
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo topical without occlusion
    Intervention Type
    Drug
    Intervention Name(s)
    Cantharidin
    Other Intervention Name(s)
    2,6-Dimethyl-4,10-dioxatricyclo-decane-3,5-dione
    Intervention Description
    cantharidin 0.7% topical liquid
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    flexible collodion
    Intervention Description
    Placebo topical liquid
    Intervention Type
    Device
    Intervention Name(s)
    Gauze occlusion bandage
    Intervention Description
    Gauze occlusion bandage with adhesive tape
    Primary Outcome Measure Information:
    Title
    Number of Subjects Who Achieve Complete Clearance at 6 Weeks
    Description
    Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Number of Subjects Who Experienced an Adverse Event
    Description
    Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit
    Time Frame
    33 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 2-17years Healthy <50 molluscum contagiosum lesions Exclusion Criteria: Immunosuppressed Oral corticosteroids Sexually active/pregnant

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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