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

November 16, 2020 updated by: Aclaris Therapeutics, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

426

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Aclaris Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Aclaris Investigational Site
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Aclaris Investigational Site
      • Hot Springs, Arkansas, United States, 71913
        • Aclaris Investigational Site
    • California
      • Encinitas, California, United States, 92024
        • Aclaris Investigational Site
      • Fountain Valley, California, United States, 92708
        • Aclaris Investigational Site
      • San Diego, California, United States, 92123
        • Aclaris Investigational Site
      • San Diego, California, United States, 92121
        • Aclaris Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80210
        • Aclaris Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Aclaris Investigational Site
      • Jacksonville, Florida, United States, 32256
        • Aclaris Investigational Site
      • Miami, Florida, United States, 33144
        • Aclaris Investigational Site
      • Miami, Florida, United States, 33134
        • Aclaris Investigational Site
      • Ocala, Florida, United States, 34470
        • Aclaris Investigational Site
    • Georgia
      • Newnan, Georgia, United States, 30263
        • Aclaris Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Aclaris Investigational Site
      • New Albany, Indiana, United States, 47150
        • Aclaris Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Aclaris Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Aclaris Investigational Site
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Aclaris Investigational Site
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Aclaris Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Aclaris Investigational Sites
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Aclaris Investigational Site
    • New Jersey
      • Verona, New Jersey, United States, 07044
        • Aclaris Investigational Site
    • New York
      • Rochester, New York, United States, 14623
        • Aclaris Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Aclaris Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Aclaris Investigational Site
      • Bexley, Ohio, United States, 43209
        • Aclaris Investigational Site
    • Pennsylvania
      • Broomall, Pennsylvania, United States, 19008
        • Aclaris Invesgational Site
      • Fort Washington, Pennsylvania, United States, 19034
        • Aclaris Investigational Site
      • Upper Saint Clair, Pennsylvania, United States, 15241
        • Aclaris Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29644
        • Aclaris Investigational Site
      • Charleston, South Carolina, United States, 29407
        • Aclaris Investigational Site
      • Fountain Inn, South Carolina, United States, 29644
        • Aclaris Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Aclaris Investigational Site
      • Nashville, Tennessee, United States, 37215
        • Aclaris Investigational Site
    • Texas
      • Arlington, Texas, United States, 76011
        • Aclaris Investigational Site
      • Austin, Texas, United States, 78759
        • Aclaris Investigational Site
      • College Station, Texas, United States, 77845
        • Aclaris Investigational Site
      • Houston, Texas, United States, 77598
        • Aclaris Investigational Site
      • Pflugerville, Texas, United States, 78660
        • Aclaris Investigational Site
      • San Antonio, Texas, United States, 78213
        • Aclaris Investigational Site
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Aclaris Investigational Site
      • Norfolk, Virginia, United States, 23502
        • Aclaris Investigational Site
      • Norfolk, Virginia, United States, 23507
        • Aclaris Investigational Site
    • Washington
      • Spokane, Washington, United States, 99202
        • Aclaris Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A-101
Topical Solution
Drug: A-101
hydrogen peroxide topical solution 45%
Other Names:
  • hydrogen peroxide 45%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts
Time Frame: Baseline to a maximum of 341 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Baseline to a maximum of 207 days

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
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)
Time Frame: Baseline to a maximum of 248 days

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
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)
Time Frame: Baseline to a maximum of 290 days

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
Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 1)
Time Frame: Baseline to a maximum of 207 days

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
Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 2)
Time Frame: Baseline to a maximum of 248 days

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
Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 3)
Time Frame: Baseline to a maximum of 290 days

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
Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 1)
Time Frame: Baseline to a maximum of 207 days

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
Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 2)
Time Frame: Baseline to a maximum of 248 days

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
Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 3)
Time Frame: Baseline to a maximum of 290 days

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
Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 1)
Time Frame: Baseline to a maximum of 207 days

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
Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 2)
Time Frame: Baseline to a maximum of 248 days

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
Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 3)
Time Frame: Baseline to a maximum of 290 days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aclaris Therapeutics, Inc.

Investigators

  • Study Director: David Gordon, MB, ChB, Aclaris Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 7, 2019

Primary Completion (ACTUAL)

November 27, 2019

Study Completion (ACTUAL)

December 20, 2019

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 18, 2019

First Posted (ACTUAL)

January 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-101-WART-303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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