A Study of A-101 Solution in Subjects With Common Warts.
Condition: Common Warts
MeSH terms: Warts
Intervention: A-101 Solution 40; A-101 Solution 45; Vehicle Solution
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment
      groups.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is at least 18 years of age

          2. Subject has a clinical diagnosis of common warts

          3. Subject has 1 appropriate Target Wart as defined below, on the trunk or extremities:

               -  Have a longest axis that is 3mm to 10mm

               -  Have a thickness ≤3mm

               -  Be a discrete lesion

               -  Be, when centered in the circular cutout of the provided template, the only
                  common wart present

               -  Not be periungual, subungual, genital or anal

               -  Not be covered with hair which, in the Investigator's opinion, would interfere
                  with the study medication treatments or the study evaluations Not be in an area
                  that may be occluded (by clothing, footwear or within a skin fold).

          4. The Target Wart has a Physician Wart Assessment (PWA) ≥2

          5. If the subject is a woman of childbearing potential, she has a negative urine
             pregnancy test and agrees to use an approved effective method of birth control for the
             duration of the study

          6. Subject is non-pregnant and non-lactating

          7. Subject is in good general health and free of any known disease state or physical
             condition which, in the Investigator's opinion, might put the subject at undue risk by
             study participation or interfere with the study conduct or evaluations

          8. Subject is willing and able to follow all study instructions and to attend all study
             visits

          9. Subject is able to comprehend and willing to sign an Informed Consent Form.

        Exclusion Criteria:

          1. Subject has clinically atypical warts on the trunk or extremities

          2. Subject is immune compromised (due to chemotherapy, systemic steroids, genetic
             immunodeficiency, transplant status, etc.)

          3. Subject has a history of Human Immunodeficiency Virus (HIV) infection

          4. Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to
             enrollment

          5. Subject has used any of the following intralesional therapies within the specified
             period prior to enrollment to the Target Wart:

               -  Immunotherapy (Candida antigen, mumps antigen, Trichophyton antigen);

               -  Anti-metabolite therapy (bleomycin, 5-fluorouracil)

          6. Subject has used any of the following systemic therapies within the specified period
             prior to enrollment:

               -  Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept,
                  infliximab);

               -  Glucocortico-steroids (inhaled and intra-nasal steroids are permitted);

          7. Subject has used any of the following topical therapies within the specified period
             prior to enrollment on, or in a proximity to the Target Wart, which in the
             Investigator's opinion, might put the subject at undue risk by study participation or
             interfere with the study conduct or evaluations:

             - LASER (pulsed-dye laser), light (intense pulsed light, photo-dynamic therapy, other
             energy based therapy); Immuno-therapy ( imiquimod, squaric acid dibutyl ester, etc.);
             Anti-metabolite therapy (5-fluorouracil); Retinoids; Liquid nitrogen,
             electrodesiccation, curettage; Over-the-counter wart therapies

          8. Subject has had any of the following within the specified period prior to enrollment
             on, or in a proximity to the target lesion, which in the Investigator's opinion, might
             put the subject at undue risk by study participation or interfere with the study
             conduct or evaluations:

               -  A cutaneous malignancy;

               -  A pre-malignancy (actinic keratosis)

          9. Subject has a history of sensitivity to any of the ingredients in the study
             medications

         10. Subject has any current skin disease (psoriasis, atopic dermatitis, eczema, sun
             damage, etc.), skin condition (sunburn, open wounds) or other disease or condition
             (uncontrolled diabetes) which, in the Investigator's opinion, might put the subject at
             undue risk by study participation or interfere with the study conduct or evaluations

         11. Subject has participated in an investigational drug trial in which administration of
             an investigational study medication occurred within 30 days prior to enrollment.