A Study to Evaluate the Safety and Efficacy of SB206 in Subjects With Molluscum Contagiosum
Condition: Molluscum Contagiosum
MeSH terms: Molluscum Contagiosum
Intervention: SB206 4%; SB206 8%; SB206 12%; Placebo
Intervention description: Twice daily; Twice daily; Once or twice daily; Once or twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 256.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase 2 multi-center, randomized, double-blind, vehicle-controlled ascending dose
      study to be conducted in non-immunocompromised subjects with molluscum contagiosum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be 2 years of age or older, and in good general health;

          -  Have signed written informed consent form by a parent or legal guardian (assent form
             where required);

          -  Have between 3 and 70 MC at baseline, excluding periocular (within 2 cm circumference
             of the eye) and lesions on the labia and penis;

          -  Females 10 years of age and older must have a negative urine pregnancy test prior to
             randomization;

          -  Females 10 years of age and older must agree to use an effective method of birth
             control during the course of the study and for 30 days after their final study visit;

          -  Be willing and able to follow study instructions and likely to complete all study
             requirements.

        Exclusion Criteria:

          -  Are immunosuppressed, have immunodeficiency disorder, or are on immunosuppressive
             treatment;

          -  Have agminated MC that could make it difficult to provide accurate lesion counts;

          -  Have active atopic dermatitis with intense erythema and/or excoriations, that impact
             currently or could impact at any point during the study the ability to count MC
             lesions;

          -  Have significant eczematous reactions or other skin disease surrounding MC that may
             impact the ability to 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 OTC products including, but not limited to,
             Zymaderm and tea tree oil, cimetidine and other histamine H2 receptor antagonists;

          -  Have received surgical procedures (cryotherapy, curettage, other) within 28 days prior
             to baseline;

          -  Have MC only in periocular area;

          -  Have MC only on the labia or penis;

          -  Female subjects who are pregnant, planning a pregnancy or breastfeeding;

          -  Have confirmed methemoglobin level of >3.0% at Baseline using a pulse co-oximeter;

          -  Have know hypersensitivity to any ingredients of SB206 or Vehicle Gel including
             excipients;

          -  Have participated in a previous study with NVN1000;

          -  Have participated in any other trial of an interventional investigational drug or
             device within 30 days or concurrent participation in another interventional research
             study.