A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Molluscum Contagiosum

Intervention / Treatment
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* Drug: SB206 12%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB206 12%<br>SB206 12% topically once daily | Drug: SB206 12%<br>* Topically once daily<br>* Other names: berdazimer sodium;|
| Placebo Comparator: Placebo<br>Placebo topically once daily | Drug: Placebo<br>* Topically once daily<br>* Other names: Vehicle Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Clearance of All Treatable MC at Week 12 | 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). | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Clearance of All Treatable MC at Week 8 | Percent (proportion) of subjects with complete clearance of all treatable MC at Week 8. This was measured by dividing the number of subjects who showed complete clearance at week 8 by the number in that treatment group (this represents our secondary outcome variable). | 8 Weeks |