A Phase 3 Randomized, Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE2)

• Sponsor: Novan, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03927703
• Collaborator: Synteract, Inc. (Industry)
• Enrollment: 355
• Locations: 27
• Arms: 2
• Actual Duration (Months): 8
• Patients Per Site: 13.1
• Patients Per Site Per Month: 1.6

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: 355 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: Jun 5, 2019
• Actual Primary Completion Date: Nov 11, 2019
• Actual Study Completion Date: Feb 3, 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 Comparator 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 #266	Scottsdale	Arizona	United States	85255
2	Site #101	Hot Springs	Arkansas	United States	71913
3	Site #282	Beverly Hills	California	United States	90212
4	Site #113	San Diego	California	United States	92123
5	Site #257	Thornton	Colorado	United States	80233
6	Site #268	Boynton Beach	Florida	United States	33437
7	Site #292	DeLand	Florida	United States	32720
8	Site #278	Miami	Florida	United States	33175
9	Site #305	Tampa	Florida	United States	33613
10	Site #175	New Albany	Indiana	United States	47150
11	Site #294	Owensboro	Kentucky	United States	42301
12	Site #289	Metairie	Louisiana	United States	70006
13	Site #297	New Orleans	Louisiana	United States	70124
14	Site #275	Largo	Maryland	United States	20774
15	Site #274	Clarkston	Michigan	United States	48346
16	Site #121	Fridley	Minnesota	United States	55448
17	Site #206	Omaha	Nebraska	United States	68144
18	Site #304	Portsmouth	New Hampshire	United States	03801
19	Site #201	Berlin	New Jersey	United States	08009
20	Site #108	Rochester	New York	United States	14623
21	Site #309	Portland	Oregon	United States	97223
22	Site #255	Mount Pleasant	South Carolina	United States	29464
23	Site #271	Knoxville	Tennessee	United States	37938
24	Site #167	Houston	Texas	United States	77030
25	Site #293	Plano	Texas	United States	75024
26	Site #281	Syracuse	Utah	United States	84075
27	Site #267	Richmond	Virginia	United States	23294

Sponsors and Collaborators

• Novan, Inc.
• Synteract, Inc.

Investigators

• Principal Investigator: Adelaide Hebert, MD, UTHealth McGovern Medical School, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novan, Inc.
• ClinicalTrials.gov Identifier: NCT03927703
• Other Study ID Numbers: NI-MC302
• First Posted: Apr 25, 2019
• Last Update Posted: Feb 18, 2020
• 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 Feb 18, 2020