Clinical trial NCT03927716: A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)
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: 352
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: Mobile
country: United States
facility: Site #218
state: Alabama
city: Glendale
country: United States
facility: Site #312
state: Arizona
city: Little Rock
country: United States
facility: Site #298
state: Arkansas
city: Rogers
country: United States
facility: Site #272
state: Arkansas
city: Lomita
country: United States
facility: Site #140
state: California
city: Boca Raton
country: United States
facility: Site #287
state: Florida
city: Jacksonville
country: United States
facility: Site #303
state: Florida
city: Miami Lakes
country: United States
facility: Site #286
state: Florida
city: Miami
country: United States
facility: Site #264
state: Florida
city: West Palm Beach
country: United States
facility: Site #273
state: Florida
city: Newnan
country: United States
facility: Site #116
state: Georgia
city: Boise
country: United States
facility: Site #302
state: Idaho
city: Chicago
country: United States
facility: Site #280
state: Illinois
city: Evansville
country: United States
facility: Site #288
state: Indiana
city: Indianapolis
country: United States
facility: Site #251
state: Indiana
city: Louisville
country: United States
facility: Site #117
state: Kentucky
city: Metairie
country: United States
facility: Site #289
state: Louisiana
city: Monroe
country: United States
facility: Site #219
state: Louisiana
city: Silver Spring
country: United States
facility: Site #308
state: Maryland
city: Beverly
country: United States
facility: Site #296
state: Massachusetts
city: Clinton Township
country: United States
facility: Site #243
state: Michigan
city: Greensboro
country: United States
facility: Site #279
state: North Carolina
city: Dublin
country: United States
facility: Site #270
state: Ohio
city: Norman
country: United States
facility: Site #252
state: Oklahoma
city: Gresham
country: United States
facility: Site #237
state: Oregon
city: Warwick
country: United States
facility: Site #311
state: Rhode Island
city: Charleston
country: United States
facility: Site #259
state: South Carolina
city: Fountain Inn
country: United States
facility: Site #295
state: South Carolina
city: Kingsport
country: United States
facility: Site #291
state: Tennessee
city: Austin
country: United States
facility: Site #183
state: Texas
city: Katy
country: United States
facility: Site #269
state: Texas
city: Longview
country: United States
facility: Site #299
state: Texas
city: San Antonio
country: United States
facility: Site #224
state: Texas
city: Salt Lake City
country: United States
facility: Site #277
state: Utah
city: Lynchburg
country: United States
facility: Site #285
state: Virginia
Study officials:
affiliation: Northwestern University
name: Amy Paller, 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.