A Study of A-101 Solution in Subjects With Common Warts.

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

Detailed Description
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This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups. During Visit 1, the Investigator will identify 1 eligible common wart on the trunk or extremities on each subject. The wart will be treated up to a maximum of 8 times at 1 week intervals during the study.

Official Title
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A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Solution in Subjects With Common Warts.

Conditions
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Common Warts

Intervention / Treatment
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* Drug: A-101 Solution 40
* Drug: A-101 Solution 45
* Drug: Vehicle Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years of age Subject has a clinical diagnosis of common warts 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). The Target Wart has a Physician Wart Assessment (PWA) ≥2 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 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 put the subject at undue risk by study participation or interfere with the study conduct or evaluations Subject is willing and able to follow all study instructions and to attend all study visits Subject is able to comprehend and willing to sign an Informed Consent Form. Exclusion Criteria: Subject has clinically atypical warts on the trunk or extremities Subject is immune compromised (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 enrollment 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) 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); 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 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) Subject has a history of sensitivity to any of the ingredients in the study medications 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 Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.

Ages Eligible for Study
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Minimum Age: 18 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: A-101 Solution 40<br>A-101 Solution 40% administered once per week | Drug: A-101 Solution 40<br> <br> |
| Experimental: A-101 Solution 45<br>A-101 Solution 45% administered once per week | Drug: A-101 Solution 45<br> <br> |
| Placebo Comparator: Vehicle Solution<br>Vehicle Solution administered once per week | Drug: Vehicle Solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Based on Mean Change in Physician Wart Assessment Over Time | The primary effectiveness will consist of the mean change from Visit 2 to Visit 10 in Physician Wart Assessment (PWA) performed using Analysis of Covariance (ANCOVA) with Visit 2 PWA as the covariate. Physician Wart Analysis is a measurement scale from 0 to 3 that evaluates the wart with 0 being clear and 3 being clinically diagnosable wart that is raised, with an obviously rough surface. | 57 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13 | Percentage of subjects whose target wart was clear at Visit 10 and who remained clear at Visit 13 for active treatment groups | visit 10 to visit 13 | 
| PWA Responder | The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10. | Day 57 |