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

Steven R Cohen30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Molluscum Contagiosum

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Participants With Total Lesion Clearance

100% reduction in baseline lesion count

Time frame: Assessed at each visit, until final visit on week 12

Secondary Outcomes

Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions

Time frame: At study completion, up to 12 weeks

Change in the Total Children's Dermatology Life Quality Index Score

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

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)

Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260)

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)