A Phase 3 Molluscum Contagiosum Efficacy and Safety Study

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 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
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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 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.

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 10.3% berdazimer
* Drug: vehicle gel


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 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 9.4. 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); Have more than one other family member participating in this study (NI-MC304); Have at least 1 family member currently participating in a study, other than this study, with a berdazimer containing product (i.e. 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 10.3% berdazimer<br>SB206 10.3% berdazimer topically once daily | Drug: SB206 10.3% berdazimer<br>* Topically once daily<br>* Other names: SB206 12% berdazimer sodium;|
| Placebo Comparator: vehicle gel<br>Vehicle gel topically once daily | Drug: vehicle gel<br>* Topically once daily<br>|

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 |
| --- | --- | --- |
| A Lesion Count of 0 or 1 of All Treatable MC at Week 12 | Percent (proportion) of subjects achieving 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 | Percent (proportion) of subjects achieving at least a 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 | 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 | 
| Change From Baseline in the Number of All Treatable MC at Week 4 | Percent change from Baseline in the number of all treatable MC at Week 4 | 4 Weeks |