A Phase 3 Efficacy & Safety of SB206 & Vehicle Gel for the Treatment of MC
B-SIMPLE2
A Phase 3 Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy and Safety of SB206 and Vehicle Gel Once Daily in the Treatment of Molluscum Contagiosum
1 other identifier
interventional
355
1 country
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2019
Shorter than P25 for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2019
CompletedFirst Posted
Study publicly available on registry
April 25, 2019
CompletedStudy Start
First participant enrolled
June 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2020
CompletedResults Posted
Study results publicly available
January 20, 2023
CompletedMarch 23, 2023
March 1, 2023
5 months
April 23, 2019
October 18, 2022
March 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Complete Clearance of All Treatable MC at Week 12
Percent (proportion) of subjects with complete clearance of all treatable MC at Week 12. This was measured by dividing the number of subjects who showed complete clearance by the number in that treatment group (this represents our primary outcome variable).
12 Weeks
Secondary Outcomes (1)
Complete Clearance of All Treatable MC at Week 8
8 Weeks
Study Arms (2)
SB206 12%
EXPERIMENTALSB206 12% topically once daily
Placebo Comparator
PLACEBO COMPARATORPlacebo topically once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novan, Inc.lead
- Synteract, Inc.collaborator
Study Sites (27)
Site #266
Scottsdale, Arizona, 85255, United States
Site #101
Hot Springs, Arkansas, 71913, United States
Site #282
Beverly Hills, California, 90212, United States
Site #113
San Diego, California, 92123, United States
Site #257
Thornton, Colorado, 80233, United States
Site #268
Boynton Beach, Florida, 33437, United States
Site #292
DeLand, Florida, 32720, United States
Site #278
Miami, Florida, 33175, United States
Site #305
Tampa, Florida, 33613, United States
Site #175
New Albany, Indiana, 47150, United States
Site #294
Owensboro, Kentucky, 42301, United States
Site #289
Metairie, Louisiana, 70006, United States
Site #297
New Orleans, Louisiana, 70124, United States
Site #275
Largo, Maryland, 20774, United States
Site #274
Clarkston, Michigan, 48346, United States
Site #121
Fridley, Minnesota, 55448, United States
Site #206
Omaha, Nebraska, 68144, United States
Site #304
Portsmouth, New Hampshire, 03801, United States
Site #201
Berlin, New Jersey, 08009, United States
Site #108
Rochester, New York, 14623, United States
Site #309
Portland, Oregon, 97223, United States
Site #255
Mt. Pleasant, South Carolina, 29464, United States
Site #271
Knoxville, Tennessee, 37938, United States
Site #167
Houston, Texas, 77030, United States
Site #293
Plano, Texas, 75024, United States
Site #281
Syracuse, Utah, 84075, United States
Site #267
Richmond, Virginia, 23294, United States
Related Publications (1)
Maeda-Chubachi T, Hebert D, Messersmith E, Siegfried EC. SB206, a Nitric Oxide-Releasing Topical Medication, Induces the Beginning of the End Sign and Molluscum Clearance. JID Innov. 2021 May 5;1(3):100019. doi: 10.1016/j.xjidi.2021.100019. eCollection 2021 Sep.
PMID: 34909721DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cathy White, Vice President, Drug Development Operations
- Organization
- Novan
Study Officials
- PRINCIPAL INVESTIGATOR
Adelaide Hebert, MD
UTHealth McGovern Medical School, Houston
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2019
First Posted
April 25, 2019
Study Start
June 13, 2019
Primary Completion
November 11, 2019
Study Completion
February 3, 2020
Last Updated
March 23, 2023
Results First Posted
January 20, 2023
Record last verified: 2023-03