A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)
Condition: Molluscum Contagiosum
MeSH terms: Molluscum Contagiosum
Intervention: SB206 12%; Placebo
Intervention description: Topically once daily; Topically once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 352.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No

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.
    

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.