A Phase 3 Molluscum Contagiosum Efficacy and Safety Study
Condition: Molluscum Contagiosum
MeSH terms: Molluscum Contagiosum
Intervention: SB206 10.3% berdazimer; vehicle gel
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: 891.0
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 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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be 6 months of age or older, and in good general health;

          2. Have a documented informed consent form signed by subject or a parent or legal
             guardian and an assent form as required;

          3. Have between 3 and 70 treatable MC lesions at Baseline;

          4. 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.

          5. Have a device (phone, tablet, personal computer, etc.) that will support remote
             visits, including a camera;

          6. Be willing and able to follow study instructions and likely to complete all study
             requirements, including remote study visits.

        Exclusion Criteria:

          1. Have strongly suggested sexually transmitted MC and do not agree to refrain from
             sexual activities throughout the study period;

          2. Are immunosuppressed, have immunodeficiency disorder, or are on immunosuppressive
             treatment;

          3. Have significant injury on and/or surrounding MC that may impact ability to treat and
             count lesions;

          4. Have received treatment with topical calcineurin inhibitors or steroids on MC or
             within 2 cm of MC lesions within 14 days prior to Baseline;

          5. 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);

          6. Have received surgical procedures related to MC (e.g. cryotherapy, curettage) within
             14 days prior to Baseline;

          7. Have MC only in periocular area;

          8. Female subjects who are pregnant, planning a pregnancy or breastfeeding;

          9. Have known hypersensitivity to any ingredients of SB206 or Vehicle Gel including
             excipients;

         10. Have participated in a previous study with a berdazimer containing product (i.e.
             SB204, SB206, SB208, SB414);

         11. Have more than one other family member participating in this study (NI-MC304);

         12. 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);

         13. Have participated in any other trial of an interventional investigational drug or
             device within 14 days or concurrent participation in another interventional research
             study;

         14. 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.