A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)
NCT ID: NCT03927716
Last Updated: 2022-12-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
352 participants
INTERVENTIONAL
2019-06-03
2020-01-29
Brief Summary
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Detailed Description
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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. Subjects or their caregivers will continue to treat the area until the next scheduled visit even if the lesion(s) clear. If the investigator determines all lesions are cleared at a clinic visit, the treatment may stop. Subjects will visit the clinic at Screening/Baseline, Week 2, Week 4, Week 8, Week 12. In addition, subjects will be seen in the clinic for a safety follow-up at Week 24.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SB206 12%
SB206 12% topically once daily
SB206 12%
Topically once daily
Placebo
Placebo topically once daily
Placebo
Topically once daily
Interventions
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SB206 12%
Topically once daily
Placebo
Topically once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Months
ALL
No
Sponsors
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Synteract, Inc.
INDUSTRY
Novan, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Amy Paller, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Site #218
Mobile, Alabama, United States
Site #312
Glendale, Arizona, United States
Site #298
Little Rock, Arkansas, United States
Site #272
Rogers, Arkansas, United States
Site #140
Lomita, California, United States
Site #287
Boca Raton, Florida, United States
Site #303
Jacksonville, Florida, United States
Site #264
Miami, Florida, United States
Site #286
Miami Lakes, Florida, United States
Site #273
West Palm Beach, Florida, United States
Site #116
Newnan, Georgia, United States
Site #302
Boise, Idaho, United States
Site #280
Chicago, Illinois, United States
Site #288
Evansville, Indiana, United States
Site #251
Indianapolis, Indiana, United States
Site #117
Louisville, Kentucky, United States
Site #289
Metairie, Louisiana, United States
Site #219
Monroe, Louisiana, United States
Site #308
Silver Spring, Maryland, United States
Site #296
Beverly, Massachusetts, United States
Site #243
Clinton Township, Michigan, United States
Site #279
Greensboro, North Carolina, United States
Site #270
Dublin, Ohio, United States
Site #252
Norman, Oklahoma, United States
Site #237
Gresham, Oregon, United States
Site #311
Warwick, Rhode Island, United States
Site #259
Charleston, South Carolina, United States
Site #295
Fountain Inn, South Carolina, United States
Site #291
Kingsport, Tennessee, United States
Site #183
Austin, Texas, United States
Site #269
Katy, Texas, United States
Site #299
Longview, Texas, United States
Site #224
San Antonio, Texas, United States
Site #277
Salt Lake City, Utah, United States
Site #285
Lynchburg, Virginia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NI-MC301
Identifier Type: -
Identifier Source: org_study_id