A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)

Molluscum Contagiosum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927716
• Other study ID #: NI-MC301
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Molluscum Contagiosum

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