Evaluation of Systemic Exposure to VP-102 in Subjects With Molluscum Contagiosum.
Condition: Molluscum Contagiosum
MeSH terms: Molluscum Contagiosum
Intervention: VP-102 with applicator
Intervention description: Subjects will receive treatment to their molluscum contagiosum with VP-102.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Open label
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of the study is to determine the presence or absence of systemic
      cantharidin exposure from a single 24-hour dermal application of VP-102 topical film-forming
      solution [0.7% (w/v) cantharidin] (VP-102) when applied to molluscum contagiosum (molluscum)
      lesions on pediatric subjects 2 years old and older. Treatment will continue over the course
      of 3 additional 21 day intervals allowing for further evaluation of safety, efficacy and
      impact on quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be healthy subjects ages 2 years and older.

          2. Patients with 1-20 lesions may be enrolled and treated in the standard treatment group
             but are not eligible for the exposure study.

          3. Patients with 21 or more lesions may only be enrolled in the exposure group. Subjects
             participating in the Exposure group must have at least 21 lesions treated at Day 1 to
             qualify.

          4. Be otherwise medically healthy with no clinically significant medical history as
             determined by the investigator. Patients exhibiting active Atopic Dermatitis may be
             enrolled.

          5. Refrain from application of all topical agents including alcohol-based sanitary
             products and sunscreens for a minimum of 4 hours before Study drug application.
             Topical agents including alcohol-based sanitary products and sunscreens may be used
             after application of the study drug so long as they are not applied to or near treated
             skin.

          6. Refrain from swimming, bathing or prolonged immersion in water until the Study drug is
             removed.

          7. Have the ability or have a guardian able to follow study instructions and be likely to
             complete all study requirements.

          8. Provide assent in a manner approved by the institutional review board (IRB) and have a
             parent/guardian provide written informed consent as evidenced by signature on IRB
             approved assent/consent forms.

          9. Provide written authorization for use and disclosure of protected health information.

         10. Agree to allow photographs of all selected lesions to be taken and/or send photos via
             text or email to the study team for assessment at 24 hours post treatment. Photos may
             be used as part of the study data and/or marketing package. (Photographs will be
             de-identified to those outside the research team. Effort will be made to ensure that
             no photos with identifiable features are obtained).

        Exclusion Criteria:

          1. Are unable to cooperate with the requirements or visits of the study, as determined by
             the investigator.

          2. Have molluscum venereum (sexually transmitted molluscum).

          3. Have active molluscum eczema.

          4. Are systemically immunosuppressed or are receiving treatments such as chemotherapy or
             other non-topical immunosuppressive agents.

          5. Have had any previous treatment of molluscum in the past 14 days including the use of
             cantharidin, antivirals, retinoids, curettage or freezing of lesions. Additional
             treatments for molluscum should not be implemented during the course of the study.

          6. Have history of illness or any dermatologic disorder, which, in the opinion of the
             investigator will interfere with accurate counting of lesions or increase the risk of
             adverse events.

          7. History or presence of clinically significant medical, psychiatric, or emotional
             condition or abnormality that in the opinion of the investigator would compromise the
             safety of the subject or the quality of the data.

          8. Have a history or presence of hypersensitivity or an idiosyncratic reaction to the
             Study drug or related compounds, or drug product excipients.

          9. Have a condition or situation that may interfere significantly with the subject's
             participation in the study (e.g., patients who required hospitalization in the 2
             months prior to screening for an acute or chronic condition including alcohol or drug
             abuse), at the discretion of the investigator.

         10. Have received another investigational product within 14 days prior to the first
             application of the Study drug.

         11. Have been treated within 14 days with a product that contains the active ingredient in
             VP-102 (topical or homeopathic preparations) for any reason prior to screening.

         12. Are sexually active or may become sexually active and are unwilling to practice
             responsible birth control methods. Females that have reached menarche, must have a
             negative urine pregnancy test at screening and each visit prior to treatment with
             study medication.

         13. Are pregnant or breastfeeding.