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

• Sponsor: Novan, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03927716
• Collaborator: Synteract, Inc. (Industry)
• Enrollment: 352
• Locations: 35
• Arms: 2
• Actual Duration (Months): 8
• Patients Per Site: 10.1
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Molluscum Contagiosum	Drug: SB206 12%; Drug: Placebo	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 352 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 31, 2019
• Actual Primary Completion Date: Oct 28, 2019
• Actual Study Completion Date: Jan 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SB206 12% SB206 12% topically once daily	Drug: SB206 12%; Topically once daily; Other Names: berdazimer sodium
Placebo Comparator: Placebo Placebo topically once daily	Drug: Placebo; Topically once daily; Other Names: Vehicle Gel

Outcome Measures

Primary Outcome Measures

1. Complete clearance of all treatable MC at Week 12 [12 Weeks]

   Proportion of subjects with complete clearance of all treatable MC at Week 12

Secondary Outcome Measures

1. Complete clearance of all treatable MC at Week 8 [8 Weeks]

   Proportion of subjects with complete clearance of all treatable MC at Week 8

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site #218	Mobile	Alabama	United States	36608
2	Site #312	Glendale	Arizona	United States	85308
3	Site #298	Little Rock	Arkansas	United States	72212
4	Site #272	Rogers	Arkansas	United States	72758
5	Site #140	Lomita	California	United States	90717
6	Site #287	Boca Raton	Florida	United States	33046
7	Site #303	Jacksonville	Florida	United States	32256-6758
8	Site #286	Miami Lakes	Florida	United States	33014
9	Site #264	Miami	Florida	United States	33172
10	Site #273	West Palm Beach	Florida	United States	33406
11	Site #116	Newnan	Georgia	United States	30263
12	Site #302	Boise	Idaho	United States	83713
13	Site #280	Chicago	Illinois	United States	60611
14	Site #288	Evansville	Indiana	United States	47715
15	Site #251	Indianapolis	Indiana	United States	46250
16	Site #117	Louisville	Kentucky	United States	40241
17	Site #289	Metairie	Louisiana	United States	70006
18	Site #219	Monroe	Louisiana	United States	71201
19	Site #308	Silver Spring	Maryland	United States	20910
20	Site #296	Beverly	Massachusetts	United States	01915
21	Site #243	Clinton Township	Michigan	United States	48038
22	Site #279	Greensboro	North Carolina	United States	27408
23	Site #270	Dublin	Ohio	United States	43016
24	Site #252	Norman	Oklahoma	United States	73071
25	Site #237	Gresham	Oregon	United States	97030
26	Site #311	Warwick	Rhode Island	United States	02886
27	Site #259	Charleston	South Carolina	United States	29414
28	Site #295	Fountain Inn	South Carolina	United States	29644
29	Site #291	Kingsport	Tennessee	United States	37660
30	Site #183	Austin	Texas	United States	78759
31	Site #269	Katy	Texas	United States	77494
32	Site #299	Longview	Texas	United States	75605
33	Site #224	San Antonio	Texas	United States	78218
34	Site #277	Salt Lake City	Utah	United States	84124
35	Site #285	Lynchburg	Virginia	United States	24501

Sponsors and Collaborators

• Novan, Inc.
• Synteract, Inc.

Investigators

• Principal Investigator: Amy Paller, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novan, Inc.
• ClinicalTrials.gov Identifier: NCT03927716
• Other Study ID Numbers: NI-MC301
• First Posted: Apr 25, 2019
• Last Update Posted: Apr 1, 2022
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Molluscum Contagiosum

Study Results

No Results Posted as of Apr 1, 2022