Cantharidin Application in Molluscum Patients-1
Condition: Molluscum Contagiosum
MeSH terms: Molluscum Contagiosum
Intervention: VP-102 - Cantharidin, Topical Film Forming Solution; Placebo -Topical Film Forming Solution without VP-102
Intervention description: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Up to 4 applications of VP-102 will be administered to Molluscum lesions at 21-day intervals.; Placebo a single-use drug device combination product containing only the vehicle. Up to 4 applications of Placebo will be administered to Molluscum lesions at 21-day intervals.
Intervention MeSH terms: Pharmaceutical Solutions; Cantharidin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 266.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Molluscum; Skin Diseases; Poxviridae Infections; Skin Diseases; Infectious; Skin Diseases; Viral; DNA Poxvirus

Summary:

      This study is a Phase 3, randomized, double-blind, placebo-controlled, pivotal study to
      evaluate the safety and efficacy of VP-102 topical film-forming solution in subjects with
      Molluscum Contagiosum. VP-102 will be applied once every 21 days for up to 4 applications, to
      treatable molluscum contagiosum (molluscum) lesions on subjects 2 years and older. Efficacy
      will be assessed as the proportion of subjects achieving complete clearance of all treatable
      molluscum lesions (baseline and new) on the Day 84 visit.
    

Eligibility criteria:

        Inclusion Criteria:

        To qualify for inclusion in this study, subjects must:

          1. Be healthy subjects, at least 2 years of age or older.

          2. Consent to having all molluscum lesions treated and the physician must be willing to
             treat all molluscum lesions initially present. Lesions within 10mm of the eyelid
             margins or the margin of any mucosal membrane should be evaluated carefully to ensure
             that they can be safely treated. Non-mucosal genital area lesions and inflamed lesions
             are considered treatable.

          3. Be otherwise medically healthy with no clinically significant medical history as
             determined by the investigator. Subjects exhibiting active Atopic Dermatitis may be
             enrolled.

          4. On day of treatment 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 within 5cm of treated skin lesions.

          5. Refrain from swimming, bathing or prolonged immersion in water or any liquids until
             the Study drug is removed.

          6. Have the ability or have a guardian with the ability to follow study instructions and
             be likely to complete all study requirements.

          7. Provide written informed consent or assent in a manner approved by the institutional
             review board (IRB) and/or have a parent/guardian provide written informed consent as
             evidenced by the signature on an IRB approved assent/consent form.

          8. Provide written authorization for use and disclosure of protected health information.

          9. Agree to allow photographs to be taken, (selected sites only) of selected lesions at
             every visit that will be used for training, publication and future marketing
             brochures.

        Exclusion Criteria:

        Subjects will be excluded from the study if they:

          1. Are unable to cooperate with the requirements or visits of the study, as determined by
             the investigator.

          2. Are systemically immunosuppressed or are receiving treatments such as chemotherapy or
             other non-topical immunosuppressive agents.

          3. Have any lesions present at baseline in anatomic locations that the
             subject/parent/guardian or the physician is unwilling to treat.

          4. Have had any previous treatment of molluscum including the use of cantharidin,
             antivirals, retinoids, curettage or freezing of lesions in the past 14 days.
             Additional treatments should not be implemented during the course of the study.

          5. Have a 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.

          6. 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.

          7. Have a history or presence of hypersensitivity or an idiosyncratic reaction to the
             Study drug or related compounds, or drug product excipients (acetone, ethyl alcohol,
             nitrocellulose, hydroxypropyl cellulose, castor oil, camphor, gentian violet, and
             denatonium benzoate).

          8. Have a condition or situation that may interfere significantly with the subject's
             participation in the study (e.g., subjects 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.

          9. Have received another investigational product within 14 days prior to the first
             application of the Study drug.

         10. Have been treated within 14 days with a product that contains cantharidin (topical or
             homeopathic preparations) for any reason prior to screening.

         11. Are sexually active or may become sexually active and are unwilling to practice
             responsible birth control methods. (e.g., combination of condoms and foam, birth
             control pills, intrauterine device, patch, shot and vaginal ring, etc.). Withdrawal is
             not an acceptable method of birth control. Females that have reached menarche must
             have a negative urine pregnancy test at each visit prior to treatment with Study drug.

         12. Are pregnant or breastfeeding.