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

NCT03017846 | Completed Phase 2 Results

• 1 other identifier: 16-10-195
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Molluscum Contagiosum

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Total Lesion Clearance

  100% reduction in baseline lesion count

  Assessed at each visit, until final visit on week 12

Secondary Outcomes (3)

• 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

  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)

  At study completion, up to 12 weeks

Study Arms (1)

Cantharidin Treatment

EXPERIMENTAL

Subjects with lesions treated with topical cantharidin every 3 weeks up to 12 weeks.

Drug: Cantharidin

Interventions

Cantharidin DRUG

Application of topical cantharidin

Cantharidin Treatment

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Steven R Cohen: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Molluscum Contagiosum

Interventions

Cantharidin

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Anthony Guzman, MD
• Organization: Albert Einstein College of Medicine

anguzman@montefiore.org

7189208352

Study Officials

• Steven R Cohen, MD, MPH

  Albert Einstein College of Medicine Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 11, 2017
• Study Start: September 1, 2016
• Primary Completion: September 6, 2017
• Study Completion: September 6, 2017
• Last Updated: January 30, 2019
• Results First Posted: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)