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

Primary Purpose

Common Wart

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

A-101

About this trial

This is an interventional treatment trial for Common Wart focused on measuring common warts

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A-101

Arm Description

Topical Solution

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03812510

First Posted

January 10, 2019

Last Updated

November 16, 2020

Sponsor

Aclaris Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03812510

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

February 7, 2019 (Actual)

Primary Completion Date

November 27, 2019 (Actual)

Study Completion Date

December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aclaris Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Common Wart

Keywords

common warts

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

426 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A-101

Arm Type

Experimental

Arm Description

Topical Solution

Intervention Type

Drug

Intervention Name(s)

A-101

Other Intervention Name(s)

hydrogen peroxide 45%

Intervention Description

hydrogen peroxide topical solution 45%

Primary Outcome Measure Information:

Title

Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts

Description

Time Frame

Baseline to a maximum of 341 days

Secondary Outcome Measure Information:

Title

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)

Description

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.

Time Frame

Baseline to a maximum of 207 days

Title

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)

Description

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.

Time Frame

Baseline to a maximum of 248 days

Title

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)

Description

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.

Time Frame

Baseline to a maximum of 290 days

Title

Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 1)

Description

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.

Time Frame

Baseline to a maximum of 207 days

Title

Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 2)

Description

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.

Time Frame

Baseline to a maximum of 248 days

Title

Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 3)

Description

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.

Time Frame

Baseline to a maximum of 290 days

Title

Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 1)

Description

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.

Time Frame

Baseline to a maximum of 207 days

Title

Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 2)

Description

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.

Time Frame

Baseline to a maximum of 248 days

Title

Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 3)

Description

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.

Time Frame

Baseline to a maximum of 290 days

Title

Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 1)

Description

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.

Time Frame

Baseline to a maximum of 207 days

Title

Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 2)

Description

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.

Time Frame

Baseline to a maximum of 248 days

Title

Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 3)

Description

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.

Time Frame

Baseline to a maximum of 290 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 1: 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 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: 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 (other than IP from the 301/302 study) 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 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: 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 (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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Gordon, MB, ChB

Organizational Affiliation

Aclaris Therapeutics

Official's Role

Study Director

Facility Information:

Facility Name

Aclaris Investigational Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Aclaris Investigational Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85308

Country

United States

Facility Name

Aclaris Investigational Site

City

Fort Smith

State/Province

Arkansas

ZIP/Postal Code

72916

Country

United States

Facility Name

Aclaris Investigational Site

City

Hot Springs

State/Province

Arkansas

ZIP/Postal Code

71913

Country

United States

Facility Name

Aclaris Investigational Site

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

Aclaris Investigational Site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Aclaris Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

Facility Name

Aclaris Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Aclaris Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80210

Country

United States

Facility Name

Aclaris Investigational Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Aclaris Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Aclaris Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Aclaris Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Aclaris Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34470

Country

United States

Facility Name

Aclaris Investigational Site

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30263

Country

United States

Facility Name

Aclaris Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46250

Country

United States

Facility Name

Aclaris Investigational Site

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150

Country

United States

Facility Name

Aclaris Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40241

Country

United States

Facility Name

Aclaris Investigational Site

City

Rockville

State/Province

Maryland

ZIP/Postal Code

20850

Country

United States

Facility Name

Aclaris Investigational Site

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Aclaris Investigational Site

City

Saint Joseph

State/Province

Missouri

ZIP/Postal Code

64506

Country

United States

Facility Name

Aclaris Investigational Sites

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144

Country

United States

Facility Name

Aclaris Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89148

Country

United States

Facility Name

Aclaris Investigational Site

City

Verona

State/Province

New Jersey

ZIP/Postal Code

07044

Country

United States

Facility Name

Aclaris Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14623

Country

United States

Facility Name

Aclaris Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Aclaris Investigational Site

City

Beachwood

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Aclaris Investigational Site

City

Bexley

State/Province

Ohio

ZIP/Postal Code

43209

Country

United States

Facility Name

Aclaris Invesgational Site

City

Broomall

State/Province

Pennsylvania

ZIP/Postal Code

19008

Country

United States

Facility Name

Aclaris Investigational Site

City

Fort Washington

State/Province

Pennsylvania

ZIP/Postal Code

19034

Country

United States

Facility Name

Aclaris Investigational Site

City

Upper Saint Clair

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

Aclaris Investigational Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29644

Country

United States

Facility Name

Aclaris Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Aclaris Investigational Site

City

Fountain Inn

State/Province

South Carolina

ZIP/Postal Code

29644

Country

United States

Facility Name

Aclaris Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37922

Country

United States

Facility Name

Aclaris Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

Aclaris Investigational Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

Facility Name

Aclaris Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

Facility Name

Aclaris Investigational Site

City

College Station

State/Province

Texas

ZIP/Postal Code

77845

Country

United States

Facility Name

Aclaris Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Aclaris Investigational Site

City

Pflugerville

State/Province

Texas

ZIP/Postal Code

78660

Country

United States

Facility Name

Aclaris Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78213

Country

United States

Facility Name

Aclaris Investigational Site

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

Country

United States

Facility Name

Aclaris Investigational Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Facility Name

Aclaris Investigational Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Aclaris Investigational Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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

Common Wart

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial