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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03927716
Other study ID # NI-MC301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 3, 2019
Est. completion date January 29, 2020

Study information

Verified date December 2022
Source Novan, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This is a Phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in approximately 340 subjects with MC. After obtaining informed consent/assent, subjects who satisfy entry criteria will be randomized 2:1 (active:vehicle). Subjects receiving current treatment for MC at the time of the Screening Visit will enter a wash out period of up to 14 days prior to randomization. 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.


Recruitment information / eligibility

Status Completed
Enrollment 352
Est. completion date January 29, 2020
Est. primary completion date October 28, 2019
Accepts healthy volunteers No
Gender All
Age group 6 Months and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SB206 12%
Topically once daily
Placebo
Topically once daily

Locations

Country Name City State
United States Site #183 Austin Texas
United States Site #296 Beverly Massachusetts
United States Site #287 Boca Raton Florida
United States Site #302 Boise Idaho
United States Site #259 Charleston South Carolina
United States Site #280 Chicago Illinois
United States Site #243 Clinton Township Michigan
United States Site #270 Dublin Ohio
United States Site #288 Evansville Indiana
United States Site #295 Fountain Inn South Carolina
United States Site #312 Glendale Arizona
United States Site #279 Greensboro North Carolina
United States Site #237 Gresham Oregon
United States Site #251 Indianapolis Indiana
United States Site #303 Jacksonville Florida
United States Site #269 Katy Texas
United States Site #291 Kingsport Tennessee
United States Site #298 Little Rock Arkansas
United States Site #140 Lomita California
United States Site #299 Longview Texas
United States Site #117 Louisville Kentucky
United States Site #285 Lynchburg Virginia
United States Site #289 Metairie Louisiana
United States Site #264 Miami Florida
United States Site #286 Miami Lakes Florida
United States Site #218 Mobile Alabama
United States Site #219 Monroe Louisiana
United States Site #116 Newnan Georgia
United States Site #252 Norman Oklahoma
United States Site #272 Rogers Arkansas
United States Site #277 Salt Lake City Utah
United States Site #224 San Antonio Texas
United States Site #308 Silver Spring Maryland
United States Site #311 Warwick Rhode Island
United States Site #273 West Palm Beach Florida

Sponsors (2)

Lead Sponsor Collaborator
Novan, Inc. Synteract, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Complete Clearance of All Treatable MC at Week 8 Percent (proportion) of subjects with complete clearance of all treatable MC at Week 8. This was measured by dividing the number of subjects who showed complete clearance at week 8 by the number in that treatment group (this represents our secondary outcome variable). 8 Weeks
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