A Study of A-101 Topical Solution for the Treatment of Common Warts

Study Overview
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Brief Summary
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Phase 3 Study of A-101 Topical Solution in Subjects with Common Warts

Detailed Description
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A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

Official Title
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A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts

Conditions
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Common Wart

Intervention / Treatment
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* Drug: Active
* Other: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject or legal guardian is able to comprehend and is willing to sign an informed consent/assent for participation in this study. Male or female ≥ 2 years old. Subject has a clinical diagnosis of common warts (verruca vulgaris). Subject has at least 1 and up to 6 clearly identifiable common warts located on the trunk or extremities that meet the requirements as defined below: Have a longest axis that is ≥3 and ≤8 mm and have a thickness of ≤3mm Be a discrete lesion, i.e. each wart meeting the entry criteria is clearly separated from other warts. Be present for at least 4 weeks Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations Not be in an intertriginous fold Periungual, subungual, genital, anal, mosaic, plantar, flat and filiform warts are excluded from treatment and evaluation. If a subject has these types of warts, but also has warts that meet the inclusion criteria, the subject will NOT be excluded from the study. Each common wart identified for treatment must have a PWA ≥ 2. Subject's 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. 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 the identified common 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. Subject must be the only individual in a household participating in the study. Exclusion Criteria: Subject has clinically atypical common warts. 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 6 months prior to Visit 1. Subject has used any of the following intralesional therapies within the specified period prior to Visit 2: Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8 weeks 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 2: Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab); 16 weeks 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 2 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: LASER, light or other energy-based therapy (e.g., intense pulsed light [IPL], photodynamic therapy [PDT]); 180 days Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester[SADBE], etc.) 12 weeks Liquid nitrogen, electrodesiccation, curettage; 60 days Hydrogen peroxide; 90 days Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks Retinoids; 90 days 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 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: Cutaneous malignancy; 180 days Sunburn; currently 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 in which administration of an investigational treatment occurred with 30 days prior to Visit 1. Subject has an active malignancy. Subjects is viewed by the Principal Investigator as not being able to complete the study.

Ages Eligible for Study
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Minimum Age: 2 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
Interventional Model Description: Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>A-101 45% (Topical solution, hydrogen peroxide 45%) | Drug: Active<br>* A-101 45% (hydrogen peroxide 45% topical solution)<br>* Other names: hydrogen peroxide 45%;|
| Placebo Comparator: Vehicle<br>Topical solution, isopropyl alcohol and water | Other: Vehicle<br>* Vehicle solution containing isopropyl alcohol and water<br>* Other names: isopropyl alcohol and sterile water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60) | The primary efficacy endpoint is the number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 10 (Day 60). Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome. | Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Complete Clearance of All Treated Common Warts Between Active and Vehicle on the Physician Wart Assessment (PWA) Scale (PWA=0) at Visit 13 (Day 137) | Number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 13 (Day 137). Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome. | Day 137 | 
| Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale Between Active and Vehicle That Are Clear (PWA=0) at Visit 13 (Day 137) | Mean Per-Subject Percent of all Warts that were Clear on the Physician Wart Assessment (PWA) scale between Active (A-101 45%) and Vehicle that are clear (PWA=0) at Day 137. Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome. | Day 137 | 
| Number of Subjects With a Single Wart at Baseline Whose Wart Was Clear on the PWA Scale Between Active and Vehicle Group (PWA=0) at Visit 10 (Day 60) | Comparison between Active (A-101 45%) and Vehicle of subjects with a single wart at baseline, whose wart is clear (PWA=0) at Day 60. Clearance of the single wart at baseline will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome. | Day 60 | 
| Median Time for Subjects to Achieve Clearance (PWA=0) of All Treated Common Warts | Comparison between Active (A-101 45%) and Vehicle with respect to the median time to achieve onset of clearance (PWA=0) for all treated warts at Day 137. Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome. | Day 137 |