A Phase2 of A-101 Topical Solution in Subjects With Common Warts

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the effectiveness of A-101 compared to vehicle when applied to 1 common target wart on the trunk or extremities.

Detailed Description
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The primary objective of this study is to evaluate the effectiveness of A-101 compared to vehicle when applied to 1 common target wart on the trunk or extremities. The secondary objectives of this study are to evaluate the clinical effect of A-101 when applied to all treated warts (Target Warts plus Non-Target Warts), duration of response in all treated warts (Target Warts plus Non-Target Warts), and Safety of A-101.

Official Title
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A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Once a Week in Subjects With Common Warts

Conditions
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Common Wart

Intervention / Treatment
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* Drug: A-101 Topical Solution
* Drug: A-101 Vehicle Solution


Participation Criteria
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Eligibility Criteria
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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 has a clinical diagnosis of common warts. 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. Women 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 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.

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>A-101 Topical Solution | Drug: A-101 Topical Solution<br>* A-101 Topical Solution<br>|
| Placebo Comparator: Vehicle<br>Vehicle | Drug: A-101 Vehicle Solution<br>* A-101 Vehicle Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Physician's Wart Assessment Score From Baseline to Day 57 | Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length) A visible wart ≥ 3 mm and < 6 mm in maximal diameter (or length) A visible wart ≥ 6 mm in maximal diameter (or length) | Day 57 |