A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)
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
352
1 country
35
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
35 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 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2020
CompletedResults Posted
Study results publicly available
December 27, 2022
CompletedDecember 27, 2022
December 1, 2022
5 months
April 23, 2019
October 18, 2022
December 5, 2022
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
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 (35)
Site #218
Mobile, Alabama, 36608, United States
Site #312
Glendale, Arizona, 85308, United States
Site #298
Little Rock, Arkansas, 72212, United States
Site #272
Rogers, Arkansas, 72758, United States
Site #140
Lomita, California, 90717, United States
Site #287
Boca Raton, Florida, 33046, United States
Site #303
Jacksonville, Florida, 32256-6758, United States
Site #264
Miami, Florida, 33172, United States
Site #286
Miami Lakes, Florida, 33014, United States
Site #273
West Palm Beach, Florida, 33406, United States
Site #116
Newnan, Georgia, 30263, United States
Site #302
Boise, Idaho, 83713, United States
Site #280
Chicago, Illinois, 60611, United States
Site #288
Evansville, Indiana, 47715, United States
Site #251
Indianapolis, Indiana, 46250, United States
Site #117
Louisville, Kentucky, 40241, United States
Site #289
Metairie, Louisiana, 70006, United States
Site #219
Monroe, Louisiana, 71201, United States
Site #308
Silver Spring, Maryland, 20910, United States
Site #296
Beverly, Massachusetts, 01915, United States
Site #243
Clinton Township, Michigan, 48038, United States
Site #279
Greensboro, North Carolina, 27408, United States
Site #270
Dublin, Ohio, 43016, United States
Site #252
Norman, Oklahoma, 73071, United States
Site #237
Gresham, Oregon, 97030, United States
Site #311
Warwick, Rhode Island, 02886, United States
Site #259
Charleston, South Carolina, 29414, United States
Site #295
Fountain Inn, South Carolina, 29644, United States
Site #291
Kingsport, Tennessee, 37660, United States
Site #183
Austin, Texas, 78759, United States
Site #269
Katy, Texas, 77494, United States
Site #299
Longview, Texas, 75605, United States
Site #224
San Antonio, Texas, 78218, United States
Site #277
Salt Lake City, Utah, 84124, United States
Site #285
Lynchburg, Virginia, 24501, 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
Amy Paller, MD
Northwestern University
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 3, 2019
Primary Completion
October 28, 2019
Study Completion
January 29, 2020
Last Updated
December 27, 2022
Results First Posted
December 27, 2022
Record last verified: 2022-12