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

NCT03691831 | Completed Phase 3 Results FDA Drug

• 1 other identifier: A-101-WART-302
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 24

Brief Summary

Phase 3 Study of A-101 Topical Solution in Subjects with Common Warts

Conditions

Common Wart

Outcome Measures

Primary Outcomes (1)

• The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60)

  The primary efficacy endpoint is the number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 10 (Day 60). 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.

  Day 60

Secondary Outcomes (4)

• Number of Subjects With Complete Clearance of All Treated Common Warts Between Active and Vehicle on the Physician Wart Assessment (PWA) Scale (PWA=0) at Visit 13 (Day 137)

  Day 137

• Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale Between Active and Vehicle That Are Clear (PWA=0) at Visit 13 (Day 137)

  Day 137

• Number of Subjects With a Single Wart at Baseline Whose Wart Was Clear on the PWA Scale Between Active and Vehicle Group (PWA=0) at Visit 10 (Day 60)

  Day 60

• Median Time for Subjects to Achieve Clearance (PWA=0) of All Treated Common Warts

  Day 137

Study Arms (2)

Active

ACTIVE COMPARATOR

A-101 45% (Topical solution, hydrogen peroxide 45%)

Drug: Active

Vehicle

PLACEBO COMPARATOR

Topical solution, isopropyl alcohol and water

Other: Vehicle

Interventions

Active DRUG

A-101 45% (hydrogen peroxide 45% topical solution)

Also known as: hydrogen peroxide 45%

Active

Vehicle OTHER

Vehicle solution containing isopropyl alcohol and water

Also known as: isopropyl alcohol and sterile water

Vehicle

Eligibility Criteria

• Age: 2 Years+
• 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.
• Male or female ≥ 2 years old.
• Subject has a clinical diagnosis of common warts (verruca vulgaris).
• Subject has at least 1 and up to 6 clearly identifiable common warts located on the trunk or extremities that meet the requirements as defined below:
• Have a longest axis that is ≥3 and ≤8 mm and have a thickness of ≤3mm
• Be a discrete lesion, i.e. each wart meeting the entry criteria is clearly separated from other warts.
• Be present for at least 4 weeks
• Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
• Not be in an intertriginous fold
• Each common wart identified for treatment must have a PWA ≥ 2.
• Subject's chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value(s) as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
• Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of the identified common warts or which exposes the subject to an unacceptable risk by study participation.
• Subject is willing and able to follow all study instructions and to attend all study visits.
• Subject must be the only individual in a household participating in the study.

You may not qualify if:

• Subject has clinically atypical common warts.
• Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.).
• 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 2:
• 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 2:
• 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 2 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

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (24)

Aclaris Investigational Site

Glendale, Arizona, 85308, United States

Location

Aclaris Investigational Site

Fort Smith, Arkansas, 72916, United States

Location

Aclaris Investigational Site

Encinitas, California, 92024-7700, United States

Location

Aclaris Investigational Site

San Diego, California, 92121, United States

Location

Aclaris Investigational Site

Denver, Colorado, 80210, United States

Location

Aclaris Investigational Site

Coral Gables, Florida, 33134, United States

Location

Aclaris Investigational Site

Miami, Florida, 33155, United States

Location

Aclaris Investigational Site

New Albany, Indiana, 47150, United States

Location

Aclaris Investigational Site

Rockville, Maryland, 20850, United States

Location

Aclaris Investigational Site

Quincy, Massachusetts, 02169, United States

Location

Aclaris Investigational Site

Saint Joseph, Missouri, 64506, United States

Location

Aclaris Investigational Site

Omaha, Nebraska, 68144, United States

Location

Aclaris Investigational Site

Rochester, New York, 14623, United States

Location

Aclaris Investigational Site

Raleigh, North Carolina, 27612, United States

Location

Aclaris Investigational Site

Beachwood, Ohio, 44122, United States

Location

Aclaris Investigational Site

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Aclaris Investigational Site

Anderson, South Carolina, 29621, United States

Location

Aclaris Investigational Site

Knoxville, Tennessee, 37922, United States

Location

Aclaris Investigational Site

Nashville, Tennessee, 37215, United States

Location

Aclaris Investigational Site

Arlington, Texas, 76011, United States

Location

Aclaris Investigational Site

College Station, Texas, 77845, United States

Location

Aclaris Investigational Site

Houston, Texas, 77004, United States

Location

Aclaris Investigational Site

Lynchburg, Virginia, 24501, United States

Location

Aclaris Investigational Site

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Warts

Interventions

Exercise; 2-Propanol

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Propanols; Alcohols; Organic Chemicals

Results Point of Contact

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

clinicaloperations@aclaristx.com

1-833-225-2747

Study Officials

• Judy Schynder

  Aclaris Therapeutics

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The blinded vehicle solution is packaged to match the active study drug and will be stored under the same conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: October 2, 2018
• Study Start: September 13, 2018
• Primary Completion: April 21, 2019
• Study Completion: July 9, 2019
• Last Updated: October 27, 2020
• Results First Posted: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (24)