Safety Study of A-101 Topical Solution for the Treatment of Common Warts
Condition: Common Wart
MeSH terms: Warts
Intervention: A-101
Intervention description: hydrogen peroxide topical solution 45%
Intervention MeSH terms: Hydrogen Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 426.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: common warts

Summary:

      A Phase 3 Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject or legal guardian is able to comprehend and is willing to sign an informed
             consent/assent for participation in this study.

          -  Subject must have completed study participation in either A-101-WART-301 or
             A-101-WART-302.

          -  Male or female ≥ 1 years old.

          -  Subject has a clinical diagnosis of common warts (verruca vulgaris).

          -  Identified warts must have a longest axis of ≤8 mm

        Exclusion Criteria:

          -  Subject has clinically atypical warts.

          -  Subject is immunocompromised

          -  Subject has a history of Human Immunodeficiency Virus (HIV) infection.

          -  Subject has had any Human Papilloma Virus (HPV) vaccine within 6 months prior to Visit
             1.

          -  Subject has used any of the following intralesional therapies within the specified
             period prior to Visit 1:

               1. Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8
                  weeks

               2. Anti-metabolite therapy (e.g., bleomycin, 5-fluorouracil); 8 weeks

          -  Subject has used any of the following systemic therapies within the specified period
             prior to Visit 1:

               1. Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept,
                  infliximab); 16 weeks

               2. Glucocorticosteroids (inhaled and intra-nasal steroids are permitted); 28 days

          -  Subject has used any of the following topical therapies within the specified period
             prior to Visit 1 on or in the proximity to any of the common warts identified for
             treatment that in the investigator's opinion interferes with the study medication
             treatment or the study assessments:

               1. LASER, light or other energy-based therapy (e.g., intense pulsed light [IPL],
                  photodynamic therapy [PDT]); 180 days

               2. Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester [SADBE], etc.) 12
                  weeks

               3. Liquid nitrogen, electrodesiccation, curettage; 60 days

               4. Hydrogen peroxide; 90 days (other than IP from the 301/302 study)

               5. Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks

               6. Retinoids; 90 days

               7. Over-the-counter (OTC) wart therapies and cantharidin; 28 days

          -  Subject currently has or has had any of the following within the specified period
             prior to Visit 1 on or in a proximity to any of the common warts identified for
             treatment that, in the investigator's opinion, interferes with the study medication
             treatment or the study assessments:

               1. Cutaneous malignancy; 180 days

               2. Sunburn; currently

               3. Pre-malignancy (e.g., actinic keratosis); currently

          -  Subject has a history of sensitivity to any of the ingredients in the study
             medications.

          -  Subject has any current skin or systemic disease (e.g., psoriasis, atopic dermatitis,
             eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that,
             in the opinion of the investigator, might put the subject at undue risk by study
             participation or interfere with the study conduct or evaluations.

          -  Participation in another therapeutic investigational drug/device trial (other than the
             Aclaris 301 or 302 study) in which administration of an investigational treatment
             occurred within 30 days prior to Visit 1.

          -  Subject has an active malignancy.