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

NCT03812510 | Completed Phase 3 Results FDA Drug

• 1 other identifier: A-101-WART-303
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 46

Brief Summary

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

Conditions

Common Wart

Keywords

common warts

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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)

  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)

  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)

  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)

  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)

  Baseline to a maximum of 248 days

Study Arms (1)

A-101

EXPERIMENTAL

Topical Solution

Drug: A-101

Interventions

A-101 DRUG

hydrogen peroxide topical solution 45%

Also known as: hydrogen peroxide 45%

A-101

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (46)

Aclaris Investigational Site

Mobile, Alabama, 36608, United States

Location

Aclaris Investigational Site

Glendale, Arizona, 85308, United States

Location

Aclaris Investigational Site

Fort Smith, Arkansas, 72916, United States

Location

Aclaris Investigational Site

Hot Springs, Arkansas, 71913, United States

Location

Aclaris Investigational Site

Encinitas, California, 92024, United States

Location

Aclaris Investigational Site

Fountain Valley, California, 92708, United States

Location

Aclaris Investigational Site

San Diego, California, 92121, United States

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Aclaris Investigational Site

San Diego, California, 92123, United States

Location

Aclaris Investigational Site

Denver, Colorado, 80210, United States

Location

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Aventura, Florida, 33180, United States

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Jacksonville, Florida, 32256, United States

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Miami, Florida, 33134, United States

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Aclaris Investigational Site

Miami, Florida, 33144, United States

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Ocala, Florida, 34470, United States

Location

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Newnan, Georgia, 30263, United States

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Indianapolis, Indiana, 46250, United States

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New Albany, Indiana, 47150, United States

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Louisville, Kentucky, 40241, United States

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Rockville, Maryland, 20850, United States

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Fridley, Minnesota, 55432, United States

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Saint Joseph, Missouri, 64506, United States

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Aclaris Investigational Sites

Omaha, Nebraska, 68144, United States

Location

Aclaris Investigational Site

Las Vegas, Nevada, 89148, United States

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Verona, New Jersey, 07044, United States

Location

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Rochester, New York, 14623, United States

Location

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Raleigh, North Carolina, 27612, United States

Location

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Beachwood, Ohio, 44122, United States

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Bexley, Ohio, 43209, United States

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Aclaris Invesgational Site

Broomall, Pennsylvania, 19008, United States

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Aclaris Investigational Site

Fort Washington, Pennsylvania, 19034, United States

Location

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Upper Saint Clair, Pennsylvania, 15241, United States

Location

Aclaris Investigational Site

Anderson, South Carolina, 29644, United States

Location

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Charleston, South Carolina, 29407, United States

Location

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Fountain Inn, South Carolina, 29644, United States

Location

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Knoxville, Tennessee, 37922, United States

Location

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Nashville, Tennessee, 37215, United States

Location

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Arlington, Texas, 76011, United States

Location

Aclaris Investigational Site

Austin, Texas, 78759, United States

Location

Aclaris Investigational Site

College Station, Texas, 77845, United States

Location

Aclaris Investigational Site

Houston, Texas, 77598, United States

Location

Aclaris Investigational Site

Pflugerville, Texas, 78660, United States

Location

Aclaris Investigational Site

San Antonio, Texas, 78213, United States

Location

Aclaris Investigational Site

Lynchburg, Virginia, 24501, United States

Location

Aclaris Investigational Site

Norfolk, Virginia, 23502, United States

Location

Aclaris Investigational Site

Norfolk, Virginia, 23507, United States

Location

Aclaris Investigational Site

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Warts

Interventions

N-phenylacetoaminomethylene-DL-p-nitrophenylalanine

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Aclaris Clinical Operations
• Organization: Aclaris Therapeutics, Inc.

clinicaloperations@aclaristx.com

1-833-225-2747

Study Officials

• David Gordon, MB, ChB

  Aclaris Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 23, 2019
• Study Start: February 7, 2019
• Primary Completion: November 27, 2019
• Study Completion: December 20, 2019
• Last Updated: November 23, 2020
• Results First Posted: November 23, 2020

Record last verified: 2020-11

Locations

US (46)