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OpenTrials
Completed

NCT Number: NCT03017846

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

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.

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Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Cantharidin

Drug

Application of topical cantharidin

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Steven R Cohen

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2017
Registry last updated
Jan 30, 2019

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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