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

NCT03687372 | Completed Phase 3 Results FDA Drug

• 1 other identifier: A-101-WART-301
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 24

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)

• 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)

A-101

EXPERIMENTAL

topical solution

Drug: A-101

Vehicle

OTHER

topical solution

Other: vehicle

Interventions

A-101 DRUG

hydrogen peroxide topical solution 45%

Also known as: hydrogen peroxide 45%

A-101

vehicle OTHER

vehicle as a topical solution

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 ≥ 1 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.
• Subject is in good general health and free of any known disease state or physical condition.
• 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 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

Mobile, Alabama, 36608, United States

Location

Aclaris Investigational Site

Hot Springs, Arkansas, 71913, United States

Location

Aclaris Investigational Site

Fountain Valley, California, 92708, United States

Location

Aclaris Investigational site

San Diego, California, 92123, United States

Location

Aclaris Investigational Site

Aventura, Florida, 33180, United States

Location

Aclaris Investigational Site

Jacksonville, Florida, 32256, United States

Location

Aclaris Investigational Site

Miami, Florida, 33144, United States

Location

Aclaris Investigational Site

Ocala, Florida, 34470, United States

Location

Aclaris Investigational Site

Newnan, Georgia, 30263, United States

Location

Aclaris Investigational Site

Indianapolis, Indiana, 46256, United States

Location

Aclaris Investigational Site

Louisville, Kentucky, 40241, United States

Location

Aclaris Investigational Site

Chestnut Hill, Massachusetts, 02467, United States

Location

Aclaris Investigational Site

Warren, Michigan, 48088, United States

Location

Aclaris Investigational Site

Fridley, Minnesota, 55432, United States

Location

Aclaris Investigational Site

Las Vegas, Nevada, 89148, United States

Location

Aclaris Investigational Site

Verona, New Jersey, 07044, United States

Location

Aclaris Investigational Site

Broomall, Pennsylvania, 19008, United States

Location

Aclaris Investigational Site

Fort Washington, Pennsylvania, 19034, United States

Location

Aclaris Investigational Site

Charleston, South Carolina, 29407, United States

Location

Aclaris Investigational Site

Greenville, South Carolina, 29607, United States

Location

Aclaris Investigational Site

Austin, Texas, 78759, 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

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Warts

Interventions

N-phenylacetoaminomethylene-DL-p-nitrophenylalanine; 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)

Propanols; Alcohols; Organic Chemicals

Results Point of Contact

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

clinicaloperations@aclaristx.com

1-833-225-2747

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: September 27, 2018
• Study Start: September 17, 2018
• Primary Completion: June 20, 2019
• Study Completion: September 6, 2019
• Last Updated: October 5, 2020
• Results First Posted: October 5, 2020

Record last verified: 2020-09

Locations

US (24)