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Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum, Phase 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03017846
Recruitment Status : Completed
First Posted : January 11, 2017
Results First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Information provided by (Responsible Party):
Steven R Cohen, Montefiore Medical Center

Brief Summary:
Cantharidin is cited in the dermatology and pediatric literature as a valuable treatment option. Treatment is often available in private practice offices, where a prescribing physician may offer a non-FDA approved treatment on an individualized basis. The situation is different in many hospital and academic settings, such as our own for example, where the formulary is defined through a FDA-approved indication. The absence of an indication precludes its addition to many hospital formularies, thus limiting the options available to a prescribing physician and denying patient access to a treatment offered in the private practice setting. An indication and formulary status require controlled clinical trials on the safety and efficacy of cantharidin in MC. The objective of this trial is to see if this commercially-viable cantharidin formulation has a comparable safety and efficacy profile as formulations previously studied under conditions which most closely match the what has been historically done in the clinic.

Condition or disease Intervention/treatment Phase
Molluscum Contagiosum Drug: Cantharidin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2016
Actual Primary Completion Date : September 6, 2017
Actual Study Completion Date : September 6, 2017

Arm Intervention/treatment
Experimental: Cantharidin Treatment
Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.
Drug: Cantharidin
Application of topical cantharidin

Primary Outcome Measures :
  1. Number of Participants With Total Lesion Clearance [ Time Frame: Assessed at each visit, until final visit on week 12 ]
    100% reduction in baseline lesion count

Secondary Outcome Measures :
  1. Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions [ Time Frame: At study completion, up to 12 weeks ]
  2. Change in the Total Children's Dermatology Life Quality Index Score [ Time Frame: Baseline (At beginning of study, before treatment) and end of study (at study completion, week 12 or at earlier visit if all lesions have cleared) ]

    Change in the Total Children's Dermatology Life Quality Index (CDLQI) given Visit 1 prior to the first treatment and at the last study visit, up to 12 weeks. The CDLQI examines how the patient feels about the symptoms and treatment, as well as how it affects leisure, school, personal relationships, sleep, clothing choices. A total score is calculated.

    The total score for the CDLQI scores range:

    0-1 = no effect on child's life 2-6 = small effect 7-12 = moderate effect 13-18 = very large effect 19-30 = extremely large effect

  3. Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260) [ Time Frame: At study completion, up to 12 weeks ]
    Comparison of the number of subjects achieving complete lesion clearance at study completion (up to 12 weeks) to the same measure obtained in our previous study (NCT02665260)

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Diagnosis of MC by the Principal Investigator.

Maximum of 50 lesions on locations including the face, trunk, back, left or right arm, left or right leg, hands, feet, buttocks, and groin.

Execution of Informed Consent and or assent forms

Exclusion Criteria:

Patients with immunosuppression, including organ transplantation, HIV infection.

Patients utilizing immunosuppressive agents (including oral corticosteroids) will be excluded except for patients using inhaled corticosteroids, such as those utilized for asthma or allergic rhinitis.

Females who have reached menarche and are sexually active as well as pregnant patients will be excluded as the effects of this drug have not been evaluated in pregnancy.

Patients who have greater than 50 MC lesions will also be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03017846

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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Steven R Cohen
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Principal Investigator: Steven R Cohen, MD, MPH Albert Einstein College of Medicine/Montefiore Medical Center
  Study Documents (Full-Text)

Documents provided by Steven R Cohen, Montefiore Medical Center:
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Responsible Party: Steven R Cohen, Professor, Montefiore Medical Center Identifier: NCT03017846    
Other Study ID Numbers: 16-10-195
First Posted: January 11, 2017    Key Record Dates
Results First Posted: January 30, 2019
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Molluscum Contagiosum
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action