Cantharidin and Occlusion in Verruca Epithelium
Condition: Common Wart; Warts Hand; Warts; Papillomavirus Infections; DNA Virus Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Virus Diseases; Tumor Virus Infections; Verruca Vulgaris; Verruca
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Warts; Papillomavirus Infections; Skin Diseases, Infectious; DNA Virus Infections; Tumor Virus Infections; Skin Diseases, Viral; Skin Diseases
Intervention: VP-102 Cantharidin topical film forming solution; VP-102 Cantharidin, topical film forming solution
Intervention description: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 14 days between treatments.; VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 21 days between treatments.
Intervention MeSH terms: Pharmaceutical Solutions; Cantharidin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Intervention model description: This study has 2 cohorts. Cohort 1 of the study enrolled 21 subjects and has completed all subject related study activities. Analysis is to be conducted at Day 84. Cohort 2 will utilize 4 sites with an enrollment of approximately 35 subjects. The primary analysis will be conducted at Day 84 with an additional period of follow up out to Day 147.
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, open label study (Study number VP-102-105; referred to as COVE-1
      [Cantharidin and Occlusion in Verruca Epithelium]) to evaluate the efficacy, safety and
      tolerability of VP-102 treatment in subjects with common warts. This study has two Cohorts.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be healthy, immunocompetent males or females at least 2 years of age and older for
             Cohort 1 and 12 years of age and older for Cohort 2.

          2. Present with 1-6 common warts (verruca vulgaris) located anywhere on the body except
             for the following prohibited areas: the eye area (including eyelids), lips, oral
             cavity, nasal cavity, inside of the ears, palms of the hands, volar surface of the
             fingers or toes, under the finger nails (near and on the sides of the nails is allowed
             for Cohort 1, but warts near and on the sides of the nail (e.g., periungual) are not
             allowed in Cohort 2), soles of the feet, or the anogenital area. (Warts within 10 mm
             of a mucosal surface should not be treated).

          3. Have warts that are ≤10 mm in diameter and ≤3 mm in height. (Subjects with warts that
             are adjacent, touching or clustered may be included so long as the combined diameter
             in the longest direction does not exceed 10 mm. Individual lesions that are adjacent,
             touching or clustered should be counted as distinct lesions for the purposes of
             tracking, inclusion and clearance)(subjects in Cohort 2 can be pared, when necessary
             and appropriate, prior to evaluating height eligibility) .

          4. Have warts that have been present for at least 4 weeks at the time of the baseline
             visit.

          5. Consent to having all warts treated (the physician must also be willing to treat all
             warts initially present).

          6. Be otherwise medically healthy with no clinically significant medical history,
             physical examination or vital signs as determined by the investigator.

          7. Be free of any systemic or dermatologic disorder, which, in the opinion of the
             investigator, will interfere with the study results or increase the risk of Aes.

          8. Refrain from swimming, bathing or prolonged immersion in water or any liquids until
             the Study drug is removed.

          9. Have the ability, or have a guardian with the ability, to follow study instructions
             and be likely to complete all study requirements.

         10. Agree to use no wart-removing product (prescription or over-the-counter [OTC]) other
             than the Study drug during the course of the study.

         11. 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.

         12. Provide written authorization for use and disclosure of protected health information.

         13. If participating in the optional photographic portion of the study, agree to allow
             photographs of warts to be taken at each Treatment Visit by the research team and
             agree to share photos taken at home with the research team via text, email or
             in-person upload.

        Exclusion Criteria:

          1. Are unable to cooperate with the requirements or visits of the study, as determined by
             the investigator.

          2. Are systemically immunosuppressed or have required, or will require, systemic
             immunosuppressive or immunomodulatory medication (including oral or parenteral
             corticosteroids) within 30 days prior to enrollment or during the course of the study.
             (Routine use of inhaled or intranasal corticosteroids during the study is allowed)

          3. Have any chronic or acute medical condition that, in the opinion of the investigator,
             may interfere with the study results or place the subject at undue risk. (e.g., human
             immunodeficiency virus, systemic lupus erythematosus, viral hepatitis, uncontrolled
             diabetes). NOTE: Immunizations and flu shots may be administered throughout the study,
             but not within 5 days before or after treatment.

          4. Have more than 6 common warts at baseline.

          5. Present with any verruca plana, mosaiform, filiform, subungual (under the nail),
             genital or anal warts. In Cohort 2, subjects with periungual warts are also excluded.

          6. Have any warts present at baseline in an anatomic location that the subject,
             parent/guardian or the physician is unwilling to treat or are located in an area that
             cannot be easily occluded with tape.

          7. Have had any previous treatment of common warts including, but not limited to, the use
             of cantharidin, antivirals, retinoids, salicylic acid, lactic acid, hydrogen peroxide,
             candida antigen, diphencyprone, dinitrochlorobenzene, sandalwood oil, thuja oil,
             squaric acid dibutyl ester, povidone iodine, nitric oxide, curettage or freezing of
             warts in the past 14 days. In addition, these treatments or any other over-the-counter
             wart treatment should not be implemented during the course of the study.

          8. Have been treated within 14 days with a product that contains cantharidin (topical or
             homeopathic preparations) for any reason prior to screening.

          9. Have received another investigational product as part of a clinical trial within 30
             days prior to the first application of the Study drug.

         10. Currently have or have a history of epidermodysplasia verruciformis.

         11. Have a history of illness or any dermatologic disorder, which, in the opinion of the
             investigator, will interfere with accurate assessment of the warts or increase the
             risk of adverse events.

         12. Have an active malignancy or are undergoing treatment for any malignancy.

         13. Have a 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.

         14. 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).

         15. 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.

         16. 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.

         17. Are pregnant or breastfeeding.