Overview

A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)

Status:
Completed
Trial end date:
2020-01-29
Target enrollment:
0
Participant gender:
All
Summary
This is a Phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in up to approximately 340 subjects ≥6 months of age with MC. Subjects or their caregivers will apply SB206 12% or Vehicle Gel once daily for a minimum of 4 weeks and up to 12 weeks to all lesions identified at Baseline and new treatable lesions that arise during the course of the study.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novan, Inc.
Collaborator:
Synteract, Inc.
Criteria
Inclusion Criteria:

- Be 6 months of age or older, and in good general health;

- Have a written informed consent form signed by subject or a parent or legal guardian
and an assent form as required;

- Have between 3 and 70 treatable MC at Baseline;

- Female subjects age 9 and above must have a negative UPT at Baseline;

- Female subjects age 9 and above must agree to practice a medically acceptable form of
birth control during the study and for 30 days after Week 12/ET1;

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

Exclusion Criteria:

- Have strongly suggested sexually transmitted MC and do not agree to refrain from
sexual activities throughout the study period.

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

- Have significant injury on and/or surrounding MC that may impact ability to treat and
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 over the counter (OTC) products including, but
not limited to, ZymaDerm and tea tree oil, cimetidine and other histamine H2 receptor
antagonists (including Zantac);

- Have received surgical procedures related to MC (cryotherapy, curettage, other) within
14 days prior to Baseline;

- Have MC only in periocular area;

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

- Have known hypersensitivity to any ingredients of SB206 or Vehicle Gel including
excipients;

- Have participated in a previous study with a berdazimer sodium product (SB204, SB206,
SB208, SB414);

- Have more than 1 family member currently participating in a study with a berdazimer
sodium product (SB204, SB206, SB208, SB414).

- Have participated in any other trial of an interventional investigational drug or
device within 14 days or concurrent participation in another interventional research
study.

- History or presence of clinically significant medical, psychiatric, or emotional
condition that, in opinion of the investigator, would compromise the safety of the
subject or the quality of the data.