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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03812510
Other study ID # A-101-WART-303
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 7, 2019
Est. completion date December 20, 2019

Study information

Verified date November 2020
Source Aclaris Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

A Phase 3 Open Label Safety Study of A-101 Topical Solution for the Treatment of Common Warts


Recruitment information / eligibility

Status Completed
Enrollment 426
Est. completion date December 20, 2019
Est. primary completion date November 27, 2019
Accepts healthy volunteers No
Gender All
Age group 1 Year and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
A-101
hydrogen peroxide topical solution 45%

Locations

Country Name City State
United States Aclaris Investigational Site Anderson South Carolina
United States Aclaris Investigational Site Arlington Texas
United States Aclaris Investigational Site Austin Texas
United States Aclaris Investigational Site Aventura Florida
United States Aclaris Investigational Site Beachwood Ohio
United States Aclaris Investigational Site Bexley Ohio
United States Aclaris Invesgational Site Broomall Pennsylvania
United States Aclaris Investigational Site Charleston South Carolina
United States Aclaris Investigational Site College Station Texas
United States Aclaris Investigational Site Denver Colorado
United States Aclaris Investigational Site Encinitas California
United States Aclaris Investigational Site Fort Smith Arkansas
United States Aclaris Investigational Site Fort Washington Pennsylvania
United States Aclaris Investigational Site Fountain Inn South Carolina
United States Aclaris Investigational Site Fountain Valley California
United States Aclaris Investigational Site Fridley Minnesota
United States Aclaris Investigational Site Glendale Arizona
United States Aclaris Investigational Site Hot Springs Arkansas
United States Aclaris Investigational Site Houston Texas
United States Aclaris Investigational Site Indianapolis Indiana
United States Aclaris Investigational Site Jacksonville Florida
United States Aclaris Investigational Site Knoxville Tennessee
United States Aclaris Investigational Site Las Vegas Nevada
United States Aclaris Investigational Site Louisville Kentucky
United States Aclaris Investigational Site Lynchburg Virginia
United States Aclaris Investigational Site Miami Florida
United States Aclaris Investigational Site Miami Florida
United States Aclaris Investigational Site Mobile Alabama
United States Aclaris Investigational Site Nashville Tennessee
United States Aclaris Investigational Site New Albany Indiana
United States Aclaris Investigational Site Newnan Georgia
United States Aclaris Investigational Site Norfolk Virginia
United States Aclaris Investigational Site Norfolk Virginia
United States Aclaris Investigational Site Ocala Florida
United States Aclaris Investigational Sites Omaha Nebraska
United States Aclaris Investigational Site Pflugerville Texas
United States Aclaris Investigational Site Raleigh North Carolina
United States Aclaris Investigational Site Rochester New York
United States Aclaris Investigational Site Rockville Maryland
United States Aclaris Investigational Site Saint Joseph Missouri
United States Aclaris Investigational Site San Antonio Texas
United States Aclaris Investigational Site San Diego California
United States Aclaris Investigational Site San Diego California
United States Aclaris Investigational Site Spokane Washington
United States Aclaris Investigational Site Upper Saint Clair Pennsylvania
United States Aclaris Investigational Site Verona New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Aclaris Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. In the A-101-WART-303 study, subjects will be followed every 6 weeks to assess for a recurrence or development of new common warts. If a recurrence occurs or a new wart develops these subjects may return to the site to receive A-101 Topical Solution 45% twice a week for an additional treatment cycle of 8 weeks. Baseline to a maximum of 341 days
Secondary Durability of Response: Median Number of Days All Warts Remain Clear by Treatment Group and Treatment Cycle for Subjects With All Warts Achieving a Status of Clear (PWA=0) (Treatment Cycle 1) Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.
This endpoint measures the durability of response by time to wart recurrence by prior study treatment group in the Safety Population.
Baseline to a maximum of 207 days
Secondary Durability of Response: Median Number of Days All Warts Remain Clear by Treatment Group and Treatment Cycle for Subjects With All Warts Achieving a Status of Clear (PWA=0) (Treatment Cycle 2) Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.
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.
Baseline to a maximum of 248 days
Secondary Durability of Response: Median Number of Days All Warts Remain Clear by Treatment Group and Treatment Cycle for Subjects With All Warts Achieving a Status of Clear (PWA=0) (Treatment Cycle 3) Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.
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.
Baseline to a maximum of 290 days
Secondary Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 1) Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.
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.
Baseline to a maximum of 207 days
Secondary Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 2) Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.
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.
Baseline to a maximum of 248 days
Secondary Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 3) Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.
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.
Baseline to a maximum of 290 days
Secondary Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 1) Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.
Median time to achieve onset of Clearance (PWA=0) for all treated warts. 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.
Baseline to a maximum of 207 days
Secondary Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 2) Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.
Median time to achieve onset of Clearance (PWA=0) for all treated warts. 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.
Baseline to a maximum of 248 days
Secondary Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 3) Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.
Median time to achieve onset of Clearance (PWA=0) for all treated warts. 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.
Baseline to a maximum of 290 days
Secondary Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 1) Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.
The median was unable to be calculated, so the 25th percentile was used as the time to achieve onset of Clearance (PWA=0) for all treated warts. 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.
Baseline to a maximum of 207 days
Secondary Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 2) Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.
Median time to achieve onset of Clearance (PWA=0) for all treated warts. 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.
Baseline to a maximum of 248 days
Secondary Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 3) Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.
Median time to achieve onset of Clearance (PWA=0) for all treated warts. 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.
Baseline to a maximum of 290 days
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