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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

502 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-13

Study Completion Date

2019-07-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Common Wart

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The blinded vehicle solution is packaged to match the active study drug and will be stored under the same conditions.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active

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

Group Type ACTIVE_COMPARATOR

Active

Intervention Type DRUG

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

Vehicle

Topical solution, isopropyl alcohol and water

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type OTHER

Vehicle solution containing isopropyl alcohol and water

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Active

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

Intervention Type DRUG

Vehicle

Vehicle solution containing isopropyl alcohol and water

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

hydrogen peroxide 45% isopropyl alcohol and sterile water

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 ≥ 2 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. 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.
7. 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.
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 common 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:

1. Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8 weeks
2. 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:

1. Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab); 16 weeks
2. 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:

1. LASER, light or other energy-based therapy (e.g., intense pulsed light \[IPL\], photodynamic therapy \[PDT\]); 180 days
2. Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester\[SADBE\], etc.) 12 weeks
3. Liquid nitrogen, electrodesiccation, curettage; 60 days
4. Hydrogen peroxide; 90 days
5. Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks
6. Retinoids; 90 days
7. 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:

1. Cutaneous malignancy; 180 days
2. Sunburn; currently
3. 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

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Judy Schynder

Role: STUDY_DIRECTOR

Aclaris Therapeutics

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A-101-WART-302

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Active

Active

Vehicle

Vehicle

Interventions

Active

Vehicle

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Aclaris Therapeutics, Inc.

Responsible Party

Principal Investigators

Judy Schynder

Locations

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Aclaris Investigational Site

Countries

Provided Documents

Document Type: Study Protocol

Document Type: Statistical Analysis Plan

Document Type: Informed Consent Form

Other Identifiers

A-101-WART-302