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.

Study Overview

• Status: Completed
• Conditions: Molluscum Contagiosum
• Intervention / Treatment: Drug: Cantharidin

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Total Lesion Clearance	100% reduction in baseline lesion count	Assessed at each visit, until final visit on week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions		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	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)	At study completion, up to 12 weeks

Collaborators and Investigators

• Sponsor: Steven R Cohen
• Investigators: Principal Investigator: Steven R Cohen, MD, MPH, Albert Einstein College of Medicine/Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): September 6, 2017
• Study Completion (Actual): September 6, 2017

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Poxviridae Infections; Molluscum Contagiosum; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Cantharidin
• Other Study ID Numbers: 16-10-195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No