A Phase 3 Molluscum Contagiosum Efficacy and Safety Study
B-SIMPLE4
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
891
1 country
55
Brief Summary
This is a phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in up to approximately 850 subjects 6 months of age and older with molluscum contagiosum (MC). Subjects or their caregivers will apply SB206 10.3% 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 P75+ for phase_3
Started Sep 2020
Shorter than P25 for phase_3
55 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
August 27, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedFirst Posted
Study publicly available on registry
September 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2021
CompletedResults Posted
Study results publicly available
January 26, 2023
CompletedJanuary 26, 2023
November 1, 2022
8 months
August 27, 2020
November 11, 2022
January 1, 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 (4)
A Lesion Count of 0 or 1 of All Treatable MC at Week 12
12 Weeks
90% Reduction From Baseline in the Number of All Treatable MC at Week 12
12 Weeks
Complete Clearance of All Treatable MC at Week 8
8 Weeks
Change From Baseline in the Number of All Treatable MC at Week 4
4 Weeks
Study Arms (2)
SB206 10.3% berdazimer
EXPERIMENTALSB206 10.3% berdazimer topically once daily
vehicle gel
PLACEBO COMPARATORVehicle gel topically once daily
Interventions
Topically once daily
Eligibility Criteria
You may qualify if:
- Be 6 months of age or older, and in good general health;
- Have a documented 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 lesions at Baseline;
- For women of childbearing potential (WOCBP): Must have a negative urine pregnancy test prior to randomization and must agree to use an effective method of birth control during the study; Note: WOCBP and effective methods of birth control are outlined in Section 9.4.
- Have a device (phone, tablet, personal computer, etc.) that will support remote visits, including a camera;
- Be willing and able to follow study instructions and likely to complete all study requirements, including remote study visits.
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), or any agent that in the opinion of the investigator may be relevant - (e.g. wart therapies);
- Have received surgical procedures related to MC (e.g. cryotherapy, curettage) 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 containing product (i.e. SB204, SB206, SB208, SB414);
- Have more than one other family member participating in this study (NI-MC304);
- Have at least 1 family member currently participating in a study, other than this study, with a berdazimer containing product (i.e. 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
- Therapeutics, Inc.collaborator
- Synteract, Inc.collaborator
Study Sites (55)
Site #312
Glendale, Arizona, 85308, United States
Site #101
Hot Springs, Arkansas, 71913, United States
Site #272
Rogers, Arkansas, 72758, United States
Site #336
Fountain Valley, California, 92708, United States
Site #329
Fremont, California, 94538, United States
Site# 348
Fresno, California, 93711, United States
Site #161
San Diego, California, 92103, United States
Site #327
Thousand Oaks, California, 91320, United States
Site #325
Greenwood Village, Colorado, 80111, United States
Site #335
Apopka, Florida, 32703, United States
Site #342
Boca Raton, Florida, 33428, United States
Site #333
Fort Lauderdale, Florida, 33316, United States
Site #334
Homestead, Florida, 33030, United States
Site #278
Miami, Florida, 33165, United States
Site #314
Miami Lakes, Florida, 33014, United States
Site #341
Orlando, Florida, 32829, United States
Site #227
Sanford, Florida, 32771, United States
Site #305
Tampa, Florida, 33163, United States
Site #116
Newnan, Georgia, 30263, United States
Site #340
Chicago, Illinois, 60611, United States
Site #253
Rolling Meadows, Illinois, 60008, United States
Site #288
Evansville, Indiana, 47715, United States
Site #310
Plainfield, Indiana, 46168, United States
Site #328
Bowling Green, Kentucky, 42101, United States
Site #347
Lexington, Kentucky, 40517, United States
Site # 117
Louisville, Kentucky, 40241, United States
Site #294
Owensboro, Kentucky, 42301, United States
Site #321
Baton Rouge, Louisiana, 70809, United States
Site# 349
Covington, Louisiana, 70433, United States
Site #332
New Orleans, Louisiana, 70119, United States
Site #297
New Orleans, Louisiana, 70124, United States
Site #330
Rockville, Maryland, 20854, United States
Site #346
Brighton, Massachusetts, 02135, United States
Site #274
Clarkston, Michigan, 48346, United States
Site #121
New Brighton, Minnesota, 55112, United States
Site #338
Omaha, Nebraska, 68114, United States
Site #201
Berlin, New Jersey, 08009, United States
Site #331
Verona, New Jersey, 07044, United States
Site #279
Greensboro, North Carolina, 27408, United States
Site #250
Portland, Oregon, 97210, United States
Site #265
Sugarloaf, Pennsylvania, 18249, United States
Site #311
Warwick, Rhode Island, 02866, United States
Site #295
Fountain Inn, South Carolina, 29644, United States
Site #255
Summerville, South Carolina, 29486, United States
Site #291
Kingsport, Tennessee, 37660, United States
Site #326
Knoxville, Tennessee, 37909, United States
Site #316
Murfreesboro, Tennessee, 37130, United States
Site #337
Houston, Texas, 77087, United States
Site #299
Longview, Texas, 75605, United States
Site #224
San Antonio, Texas, 78218, United States
Site #281
Layton, Utah, 84041, United States
Site #345
West Jordan, Utah, 84088, United States
Site #267
Richmond, Virginia, 23294, United States
Site #339
Spokane, Washington, 99202, United States
Site #343
Morgantown, West Virginia, 26505, United States
Related Publications (2)
Browning JC, Cartwright M, Thorla I Jr, Martin SA, Olayinka-Amao O, Maeda-Chubachi T. A Patient-Centered Perspective of Molluscum Contagiosum as Reported by B-SIMPLE4 Clinical Trial Patients and Caregivers: Global Impression of Change and Exit Interview Substudy Results. Am J Clin Dermatol. 2023 Jan;24(1):119-133. doi: 10.1007/s40257-022-00733-9. Epub 2022 Oct 26.
PMID: 36287306DERIVEDBrowning JC, Enloe C, Cartwright M, Hebert A, Paller AS, Hebert D, Kowalewski EK, Maeda-Chubachi T. Efficacy and Safety of Topical Nitric Oxide-Releasing Berdazimer Gel in Patients With Molluscum Contagiosum: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2022 Aug 1;158(8):871-878. doi: 10.1001/jamadermatol.2022.2721.
PMID: 35830173DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cathy White, Vice President, Drug Development Operations
- Organization
- Novan
Study Officials
- STUDY DIRECTOR
Tomoko Maeda Chubachi, MD PhD
Novan, Inc.
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
August 27, 2020
First Posted
September 2, 2020
Study Start
September 1, 2020
Primary Completion
April 28, 2021
Study Completion
July 28, 2021
Last Updated
January 26, 2023
Results First Posted
January 26, 2023
Record last verified: 2022-11