A Study to Evaluate the Safety and Efficacy of SB206 in Subjects With Molluscum Contagiosum

• Status: Completed
• Trial end date: 2018-11-03
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 2 multi-center, randomized, double-blind, vehicle-controlled ascending dose study to be conducted in non-immunocompromised subjects with molluscum contagiosum.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novan, Inc.
• Collaborator: Premier Research Group plc

Criteria

Inclusion Criteria:

• Be 2 years of age or older, and in good general health;

• Have signed written informed consent form by a parent or legal guardian (assent form where required);

• Have between 3 and 70 MC at baseline, excluding periocular (within 2 cm circumference of the eye) and lesions on the labia and penis;

• Females 10 years of age and older must have a negative urine pregnancy test prior to randomization;

• Females 10 years of age and older must agree to use an effective method of birth control during the course of the study and for 30 days after their final study visit;

• Be willing and able to follow study instructions and likely to complete all study requirements.

Exclusion Criteria:

• Are immunosuppressed, have immunodeficiency disorder, or are on immunosuppressive treatment;

• Have agminated MC that could make it difficult to provide accurate lesion counts;

• Have active atopic dermatitis with intense erythema and/or excoriations, that impact currently or could impact at any point during the study the ability to count MC lesions;

• Have significant eczematous reactions or other skin disease surrounding MC that may impact the ability to count lesions;

• Have received treatment with topical calcineurin inhibitors or steroids on MC or within 2 cm of MC lesions within 14 days prior to baseline;

• Have received treatment for MC during the 14 days prior to baseline with podophyllotoxin, imiquimod, cantharidin, sinecatechins, topical retinoids, oral or topical zinc, or other homeopathic or OTC products including, but not limited to, Zymaderm and tea tree oil, cimetidine and other histamine H2 receptor antagonists;

• Have received surgical procedures (cryotherapy, curettage, other) within 28 days prior to baseline;

• Have MC only in periocular area;

• Have MC only on the labia or penis;

• Female subjects who are pregnant, planning a pregnancy or breastfeeding;

• Have confirmed methemoglobin level of >3.0% at Baseline using a pulse co-oximeter;

• Have know hypersensitivity to any ingredients of SB206 or Vehicle Gel including excipients;

• Have participated in a previous study with NVN1000;

• Have participated in any other trial of an interventional investigational drug or device within 30 days or concurrent participation in another interventional research study.