A Phase 3 Efficacy & Safety of SB206 & Vehicle Gel for the Treatment of MC

NCT ID: NCT03927703

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 355 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-13
• Study Completion Date: 2020-02-03

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.

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.

Conditions

Molluscum Contagiosum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SB206 12%

SB206 12% topically once daily

Group Type: EXPERIMENTAL

SB206 12%

Intervention Type: DRUG

Topically once daily

Placebo Comparator

Placebo topically once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Topically once daily

Interventions

SB206 12%

Topically once daily

Intervention Type: DRUG

Placebo

Topically once daily

Intervention Type: DRUG

Other Intervention Names

berdazimer sodium; Vehicle Gel

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synteract, Inc.

INDUSTRY

Sponsor Role: collaborator

Novan, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adelaide Hebert, MD

Role: PRINCIPAL_INVESTIGATOR

UTHealth McGovern Medical School, Houston

Locations

Site #266

Scottsdale, Arizona, United States

Site #101

Hot Springs, Arkansas, United States

Site #282

Beverly Hills, California, United States

Site #113

San Diego, California, United States

Site #257

Thornton, Colorado, United States

Site #268

Boynton Beach, Florida, United States

Site #292

DeLand, Florida, United States

Site #278

Miami, Florida, United States

Site #305

Tampa, Florida, United States

Site #175

New Albany, Indiana, United States

Site #294

Owensboro, Kentucky, United States

Site #289

Metairie, Louisiana, United States

Site #297

New Orleans, Louisiana, United States

Site #275

Largo, Maryland, United States

Site #274

Clarkston, Michigan, United States

Site #121

Fridley, Minnesota, United States

Site #206

Omaha, Nebraska, United States

Site #304

Portsmouth, New Hampshire, United States

Site #201

Berlin, New Jersey, United States

Site #108

Rochester, New York, United States

Site #309

Portland, Oregon, United States

Site #255

Mt. Pleasant, South Carolina, United States

Site #271

Knoxville, Tennessee, United States

Site #167

Houston, Texas, United States

Site #293

Plano, Texas, United States

Site #281

Syracuse, Utah, United States

Site #267

Richmond, Virginia, United States

Countries

United States

References

Maeda-Chubachi T, Hebert D, Messersmith E, Siegfried EC. SB206, a Nitric Oxide-Releasing Topical Medication, Induces the Beginning of the End Sign and Molluscum Clearance. JID Innov. 2021 May 5;1(3):100019. doi: 10.1016/j.xjidi.2021.100019. eCollection 2021 Sep.

Reference Type: DERIVED

PMID: 34909721 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NI-MC302

Identifier Type: -

Identifier Source: org_study_id