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

NCT ID: NCT03687372

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 503 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2019-09-06

Brief Summary

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

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

Conditions

Common Wart

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A-101

topical solution

Group Type: EXPERIMENTAL

A-101

Intervention Type: DRUG

hydrogen peroxide topical solution 45%

Vehicle

topical solution

Group Type: OTHER

vehicle

Intervention Type: OTHER

vehicle as a topical solution

Interventions

A-101

hydrogen peroxide topical solution 45%

Intervention Type: DRUG

vehicle

vehicle as a topical solution

Intervention Type: OTHER

Other Intervention Names

hydrogen peroxide 45%; isopropyl alcohol and sterile water

Eligibility Criteria

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

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.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aclaris Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aclaris Investigational Site

Mobile, Alabama, United States

Aclaris Investigational Site

Hot Springs, Arkansas, United States

Aclaris Investigational Site

Fountain Valley, California, United States

Aclaris Investigational site

San Diego, California, United States

Aclaris Investigational Site

Aventura, Florida, United States

Aclaris Investigational Site

Jacksonville, Florida, United States

Aclaris Investigational Site

Miami, Florida, United States

Aclaris Investigational Site

Ocala, Florida, United States

Aclaris Investigational Site

Newnan, Georgia, United States

Aclaris Investigational Site

Indianapolis, Indiana, United States

Aclaris Investigational Site

Louisville, Kentucky, United States

Aclaris Investigational Site

Chestnut Hill, Massachusetts, United States

Aclaris Investigational Site

Warren, Michigan, United States

Aclaris Investigational Site

Fridley, Minnesota, United States

Aclaris Investigational Site

Las Vegas, Nevada, United States

Aclaris Investigational Site

Verona, New Jersey, United States

Aclaris Investigational Site

Broomall, Pennsylvania, United States

Aclaris Investigational Site

Fort Washington, Pennsylvania, United States

Aclaris Investigational Site

Charleston, South Carolina, United States

Aclaris Investigational Site

Greenville, South Carolina, United States

Aclaris Investigational Site

Austin, Texas, United States

Aclaris Investigational Site

Pflugerville, Texas, United States

Aclaris Investigational Site

San Antonio, Texas, United States

Aclaris Investigational Site

Spokane, Washington, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: ICF (ages 12-17)

View Document

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form: Main ICF

View Document

Document Type: Informed Consent Form: ICF (ages 7-11)

View Document

Document Type: Informed Consent Form: PCF Photography

View Document

Other Identifiers

A-101-WART-301

Identifier Type: -

Identifier Source: org_study_id