A Study of A-101 Topical Solution Administered Twice a Week in Subjects With Common Warts
Condition: Common Wart
MeSH terms: Warts
Intervention: A-101 Topical Solution; A-101 Vehicle Solution
Intervention description: A-101 Topical Solution; A-101 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: 159.0
Sex: All
Minimum age: 8 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the effectiveness of A-101 compared to
      Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is able to comprehend and is willing to sign an informed consent/assent for
             participation in this study.

          -  Male or female ≥ 8 years old.

          -  Subject chemistry and complete blood count results are within normal limits. If any of
             the laboratory values are outside normal range, the treating investigator must assess
             the value/s as NOT clinically significant and document this in the subject's medical
             chart in order for the subject to be eligible for randomization.

          -  Woman of childbearing potential (WOCBP) must have a negative urine pregnancy test
             within 14 days of the first application of study drug and agree to use an active
             method of birth control for the duration of the study.

          -  Subject is non-pregnant and non-lactating.

          -  Subject is in good general health and free of any known disease state or physical
             condition which, in the investigator's opinion, might impair the evaluation of any
             Target and Non-Target Warts or which exposes the subject to an unacceptable risk by
             study participation.

          -  Subject is willing and able to follow all study instructions and to attend all study
             visits.

        Exclusion Criteria:

          -  Subject has clinically atypical warts on the trunk or extremities.

          -  Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic
             immunodeficiency, transplant status, etc.)

          -  Subject has a history of Human Immunodeficiency Virus (HIV) infection

          -  Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to Visit 1

          -  Subject has a history of sensitivity to any of the ingredients in the study
             medications.

          -  Subject has any current skin 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 trial in which
             administration of an investigational study medication occurred with 30 days prior to
             Visit 1.