Clinical trial NCT03927703: A Phase 3 Efficacy & Safety of SB206 & Vehicle Gel for the Treatment of MC
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Molluscum Contagiosum
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Synteract, Inc.
First posted: 2019-04-25
Enrollment: 355
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Complete Clearance of All Treatable MC at Week 12
timeFrame: 12 Weeks
Secondary outcomes:
measure: Complete Clearance of All Treatable MC at Week 8
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Site #266
state: Arizona
city: Hot Springs
country: United States
facility: Site #101
state: Arkansas
city: Beverly Hills
country: United States
facility: Site #282
state: California
city: San Diego
country: United States
facility: Site #113
state: California
city: Thornton
country: United States
facility: Site #257
state: Colorado
city: Boynton Beach
country: United States
facility: Site #268
state: Florida
city: DeLand
country: United States
facility: Site #292
state: Florida
city: Miami
country: United States
facility: Site #278
state: Florida
city: Tampa
country: United States
facility: Site #305
state: Florida
city: New Albany
country: United States
facility: Site #175
state: Indiana
city: Owensboro
country: United States
facility: Site #294
state: Kentucky
city: Metairie
country: United States
facility: Site #289
state: Louisiana
city: New Orleans
country: United States
facility: Site #297
state: Louisiana
city: Largo
country: United States
facility: Site #275
state: Maryland
city: Clarkston
country: United States
facility: Site #274
state: Michigan
city: Fridley
country: United States
facility: Site #121
state: Minnesota
city: Omaha
country: United States
facility: Site #206
state: Nebraska
city: Portsmouth
country: United States
facility: Site #304
state: New Hampshire
city: Berlin
country: United States
facility: Site #201
state: New Jersey
city: Rochester
country: United States
facility: Site #108
state: New York
city: Portland
country: United States
facility: Site #309
state: Oregon
city: Mount Pleasant
country: United States
facility: Site #255
state: South Carolina
city: Knoxville
country: United States
facility: Site #271
state: Tennessee
city: Houston
country: United States
facility: Site #167
state: Texas
city: Plano
country: United States
facility: Site #293
state: Texas
city: Syracuse
country: United States
facility: Site #281
state: Utah
city: Richmond
country: United States
facility: Site #267
state: Virginia
Study officials:
affiliation: UTHealth McGovern Medical School, Houston
name: Adelaide Hebert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.