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
Overview
- Phase
- Phase 3
- Intervention
- SB206 10.3% berdazimer
- Conditions
- Molluscum Contagiosum
- Sponsor
- Novan, Inc.
- Enrollment
- 891
- Locations
- 55
- Primary Endpoint
- Complete Clearance of All Treatable MC at Week 12
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in up to approximately 850 subjects 6 months of age and older with molluscum contagiosum (MC). Subjects or their caregivers will apply SB206 10.3% 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 up to approximately 850 subjects 6 months of age and older with molluscum contagiosum (MC). After obtaining informed consent/assent, subjects who satisfy entry criteria will be randomized 1:1 (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 treatment once daily to all lesions identified at Baseline and new lesions that arise during treatment for a minimum of 4 weeks and up to 12 weeks. If the investigator determines all lesions are cleared at a visit, the treatment may stop. If treatment is stopped due to clearance, subjects will continue regularly scheduled visits through Week 24/ET2. Study drug will be dispensed through Week 12/ET1 in case of lesion recurrence between study visits. At each visit subsequent to stopping treatment due to clearance, the investigator will determine if new lesions have occurred since the last visit, and if so, the subject or caregiver will be instructed by the investigator to re-initiate treatment. If the subject or caregiver see new lesions or re-occurrence of lesions in between visits, they should treat these lesions until the next visit. No study drug will be provided after the Week 12 visit. The subject or caregiver will apply study drug to the individual lesions. Periocular lesions will be treated if the lesions are at least 2 cm from the edge of the eye. Subjects will visit the clinic in person at Screening/Baseline, Week 2, Week 4 (unless visit is performed remotely), Week 8, Week 12, and Week 24.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be 6 months of age or older, and in good general health;
- •Have a documented 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 lesions at Baseline;
- •For women of childbearing potential (WOCBP): Must have a negative urine pregnancy test prior to randomization and must agree to use an effective method of birth control during the study; Note: WOCBP and effective methods of birth control are outlined in Section 9.
- •Have a device (phone, tablet, personal computer, etc.) that will support remote visits, including a camera;
- •Be willing and able to follow study instructions and likely to complete all study requirements, including remote study visits.
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), or any agent that in the opinion of the investigator may be relevant - (e.g. wart therapies);
- •Have received surgical procedures related to MC (e.g. cryotherapy, curettage) 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 containing product (i.e. SB204, SB206, SB208, SB414);
Arms & Interventions
SB206 10.3% berdazimer
SB206 10.3% berdazimer topically once daily
Intervention: SB206 10.3% berdazimer
vehicle gel
Vehicle gel topically once daily
Intervention: vehicle gel
Outcomes
Primary Outcomes
Complete Clearance of All Treatable MC at Week 12
Time Frame: 12 Weeks
Percent (proportion) of subjects with complete clearance of all treatable MC at Week 12. This was measured by dividing the number of subjects who showed complete clearance by the number in that treatment group (this represents our primary outcome variable).
Secondary Outcomes
- A Lesion Count of 0 or 1 of All Treatable MC at Week 12(12 Weeks)
- 90% Reduction From Baseline in the Number of All Treatable MC at Week 12(12 Weeks)
- Complete Clearance of All Treatable MC at Week 8(8 Weeks)
- Change From Baseline in the Number of All Treatable MC at Week 4(4 Weeks)