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

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With 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: Common Wart
• Intervention / Treatment: Drug: A-101; Other: vehicle

Detailed Description

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

• Study Type: Interventional
• Enrollment (Actual): 503
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Aclaris Investigational Site
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Aclaris Investigational Site
  • California
    • Fountain Valley, California, United States, 92708
      • Aclaris Investigational Site
    • San Diego, California, United States, 92123
      • 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
    • Ocala, Florida, United States, 34470
      • Aclaris Investigational Site
  • Georgia
    • Newnan, Georgia, United States, 30263
      • Aclaris Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Aclaris Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Aclaris Investigational Site
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Aclaris Investigational Site
  • Michigan
    • Warren, Michigan, United States, 48088
      • Aclaris Investigational Site
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Aclaris Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Aclaris Investigational Site
  • New Jersey
    • Verona, New Jersey, United States, 07044
      • Aclaris Investigational Site
  • Pennsylvania
    • Broomall, Pennsylvania, United States, 19008
      • Aclaris Investigational Site
    • Fort Washington, Pennsylvania, United States, 19034
      • Aclaris Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Aclaris Investigational Site
    • Greenville, South Carolina, United States, 29607
      • Aclaris Investigational Site
  • Texas
    • Austin, Texas, United States, 78759
      • Aclaris Investigational Site
    • Pflugerville, Texas, United States, 78660
      • Aclaris Investigational Site
    • San Antonio, Texas, United States, 78213
      • Aclaris Investigational Site
  • Washington
    • Spokane, Washington, United States, 99202
      • Aclaris Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject or legal guardian is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
2. Male or female ≥ 1 years old.
3. Subject has a clinical diagnosis of common warts (verruca vulgaris).

4. 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:

   1. Have a longest axis that is ≥3 and ≤8 mm and have a thickness of ≤3mm
   2. Be a discrete lesion, i.e. each wart meeting the entry criteria is clearly separated from other warts.
   3. Be present for at least 4 weeks
   4. Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
   5. Not be in an intertriginous fold
   6. Periungual, subungual, genital, anal, mosaic, plantar, flat and filiform warts are excluded from treatment and evaluation. If a subject has these types of warts, but also has warts that meet the inclusion criteria, the subject will NOT be excluded from the study.
5. Each common wart identified for treatment must have a PWA ≥ 2.
6. Subject's chemistry and complete blood count results are within normal limits.
7. Subject is in good general health and free of any known disease state or physical condition.
8. Subject is willing and able to follow all study instructions and to attend all study visits.
9. Subject must be the only individual in a household participating in the study.

Exclusion Criteria:

1. Subject has clinically atypical warts.
2. Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.).
3. Subject has a history of Human Immunodeficiency Virus (HIV) infection.
4. Subject has had any Human Papilloma Virus (HPV) vaccine within 6 months prior to Visit 1.

5. 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

6. 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

7. 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
   • Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks
   • Retinoids; 90 days
   • Over-the-counter (OTC) wart therapies and cantharidin; 28 days

8. Subject currently has or has had any of the following 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:

   • Cutaneous malignancy; 180 days
   • Sunburn; currently
   • Pre-malignancy (e.g., actinic keratosis); currently
9. Subject has a history of sensitivity to any of the ingredients in the study medications.
10. 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.
11. Participation in another therapeutic investigational drug/device trial in which administration of an investigational treatment occurred with 30 days prior to Visit 1.
12. Subject has an active malignancy.
13. Subjects is viewed by the Principal Investigator as not being able to complete the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

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%
OTHER: Vehicle; topical solution	Other: vehicle; vehicle as a topical solution; Other Names: isopropyl alcohol and sterile water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 13 (Day 137). 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 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)	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 Day 137. Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.	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)	Comparison between Active (A-101 45%) and Vehicle of subjects with a single wart at baseline, whose wart is clear (PWA=0) at Day 60. Clearance of the single wart at baseline will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.	Day 60
Median Time for Subjects to Achieve Clearance (PWA=0) of All Treated Common Warts	Comparison between Active (A-101 45%) and Vehicle with respect to the median time to achieve onset of clearance (PWA=0) for all treated warts at Day 137. Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.	Day 137

Collaborators and Investigators

• Sponsor: Aclaris Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 17, 2018
• Primary Completion (ACTUAL): June 20, 2019
• Study Completion (ACTUAL): September 6, 2019

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (ACTUAL): September 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: common warts
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: A-101-WART-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No