A Phase 3 Molluscum Contagiosum Efficacy and Safety Study

Molluscum Contagiosum Clinical Trial

— B-SIMPLE4  

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: NCT04535531
• Other study ID #: NI-MC304
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2020
• Est. completion date: July 28, 2021

Study information

• Verified date: November 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 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.

Description:

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). After obtaining informed consent/assent, subjects who satisfy entry criteria will be randomized 1:1 (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 treatment once daily to all lesions identified at Baseline and new lesions that arise during treatment for a minimum of 4 weeks and up to 12 weeks. If the investigator determines all lesions are cleared at a visit, the treatment may stop. If treatment is stopped due to clearance, subjects will continue regularly scheduled visits through Week 24/ET2. Study drug will be dispensed through Week 12/ET1 in case of lesion recurrence between study visits. At each visit subsequent to stopping treatment due to clearance, the investigator will determine if new lesions have occurred since the last visit, and if so, the subject or caregiver will be instructed by the investigator to re-initiate treatment. If the subject or caregiver see new lesions or re-occurrence of lesions in between visits, they should treat these lesions until the next visit. No study drug will be provided after the Week 12 visit. The subject or caregiver will apply study drug to the individual lesions. Periocular lesions will be treated if the lesions are at least 2 cm from the edge of the eye. Subjects will visit the clinic in person at Screening/Baseline, Week 2, Week 4 (unless visit is performed remotely), Week 8, Week 12, and Week 24.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 891
• Est. completion date: July 28, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

1. Be 6 months of age or older, and in good general health;

2. Have a documented informed consent form signed by subject or a parent or legal guardian and an assent form as required;

3. Have between 3 and 70 treatable MC lesions at Baseline;

4. 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.

5. Have a device (phone, tablet, personal computer, etc.) that will support remote visits, including a camera;

6. Be willing and able to follow study instructions and likely to complete all study requirements, including remote study visits.

Exclusion Criteria:

1. Have strongly suggested sexually transmitted MC and do not agree to refrain from sexual activities throughout the study period;

2. Are immunosuppressed, have immunodeficiency disorder, or are on immunosuppressive treatment;

3. Have significant injury on and/or surrounding MC that may impact ability to treat and count lesions;

4. Have received treatment with topical calcineurin inhibitors or steroids on MC or within 2 cm of MC lesions within 14 days prior to Baseline;

5. 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);

6. Have received surgical procedures related to MC (e.g. cryotherapy, curettage) within 14 days prior to Baseline;

7. Have MC only in periocular area;

8. Female subjects who are pregnant, planning a pregnancy or breastfeeding;

9. Have known hypersensitivity to any ingredients of SB206 or Vehicle Gel including excipients;

10. Have participated in a previous study with a berdazimer containing product (i.e. SB204, SB206, SB208, SB414);

11. Have more than one other family member participating in this study (NI-MC304);

12. 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);

13. Have participated in any other trial of an interventional investigational drug or device within 14 days or concurrent participation in another interventional research study;

14. 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 10.3% berdazimer
Topically once daily
• vehicle gel
Topically once daily

Locations

Country	Name	City	State
United States	Site #335	Apopka	Florida
United States	Site #321	Baton Rouge	Louisiana
United States	Site #201	Berlin	New Jersey
United States	Site #342	Boca Raton	Florida
United States	Site #328	Bowling Green	Kentucky
United States	Site #346	Brighton	Massachusetts
United States	Site #340	Chicago	Illinois
United States	Site #274	Clarkston	Michigan
United States	Site# 349	Covington	Louisiana
United States	Site #288	Evansville	Indiana
United States	Site #333	Fort Lauderdale	Florida
United States	Site #295	Fountain Inn	South Carolina
United States	Site #336	Fountain Valley	California
United States	Site #329	Fremont	California
United States	Site# 348	Fresno	California
United States	Site #312	Glendale	Arizona
United States	Site #279	Greensboro	North Carolina
United States	Site #325	Greenwood Village	Colorado
United States	Site #334	Homestead	Florida
United States	Site #101	Hot Springs	Arkansas
United States	Site #337	Houston	Texas
United States	Site #291	Kingsport	Tennessee
United States	Site #326	Knoxville	Tennessee
United States	Site #281	Layton	Utah
United States	Site #347	Lexington	Kentucky
United States	Site #299	Longview	Texas
United States	Site # 117	Louisville	Kentucky
United States	Site #278	Miami	Florida
United States	Site #314	Miami Lakes	Florida
United States	Site #343	Morgantown	West Virginia
United States	Site #316	Murfreesboro	Tennessee
United States	Site #121	New Brighton	Minnesota
United States	Site #297	New Orleans	Louisiana
United States	Site #332	New Orleans	Louisiana
United States	Site #116	Newnan	Georgia
United States	Site #338	Omaha	Nebraska
United States	Site #341	Orlando	Florida
United States	Site #294	Owensboro	Kentucky
United States	Site #310	Plainfield	Indiana
United States	Site #250	Portland	Oregon
United States	Site #267	Richmond	Virginia
United States	Site #330	Rockville	Maryland
United States	Site #272	Rogers	Arkansas
United States	Site #253	Rolling Meadows	Illinois
United States	Site #224	San Antonio	Texas
United States	Site #161	San Diego	California
United States	Site #227	Sanford	Florida
United States	Site #339	Spokane	Washington
United States	Site #265	Sugarloaf	Pennsylvania
United States	Site #255	Summerville	South Carolina
United States	Site #305	Tampa	Florida
United States	Site #327	Thousand Oaks	California
United States	Site #331	Verona	New Jersey
United States	Site #311	Warwick	Rhode Island
United States	Site #345	West Jordan	Utah

Sponsors (3)

Lead Sponsor	Collaborator
Novan, Inc.	Synteract, Inc., Therapeutics, 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	A Lesion Count of 0 or 1 of All Treatable MC at Week 12	Percent (proportion) of subjects achieving a lesion count of 0 or 1 of all treatable MC at Week 12.	12 Weeks
Secondary	90% Reduction From Baseline in the Number of All Treatable MC at Week 12	Percent (proportion) of subjects achieving at least a 90% reduction from Baseline in the number of all treatable MC at Week 12	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
Secondary	Change From Baseline in the Number of All Treatable MC at Week 4	Percent change from Baseline in the number of all treatable MC at Week 4	4 Weeks