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

Common Wart Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812510
• Other study ID #: A-101-WART-303
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Common Wart
• Warts

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