A Phase2 of A-101 Topical Solution in Subjects With Common Warts

Common Wart Clinical Trial

Official title:

A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Once a Week in Subjects With Common Warts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03210337
• Other study ID #: A-101-WART-202
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2017
• Est. completion date: March 16, 2018

Study information

• Verified date: March 2019
• Source: Aclaris Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the effectiveness of A-101 compared to vehicle when applied to 1 common target wart on the trunk or extremities.

Description:

The primary objective of this study is to evaluate the effectiveness of A-101 compared to vehicle when applied to 1 common target wart on the trunk or extremities.

The secondary objectives of this study are to evaluate the clinical effect of A-101 when applied to all treated warts (Target Warts plus Non-Target Warts), duration of response in all treated warts (Target Warts plus Non-Target Warts), and Safety of A-101.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: March 16, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.

• Male or female = 8 years old.

• Subject has a clinical diagnosis of common warts.

• Subject 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.

• Women of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.

• 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 any Target and Non-Target 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.

Exclusion Criteria:

• Subject has clinically atypical warts on the trunk or extremities.

• 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 1 year prior to Visit 1

• Subject has a history of sensitivity to any of the ingredients in the study medications.

• Subject has any current skin 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.

• Participation in another therapeutic investigational drug trial in which administration of an investigational study medication occurred with 30 days prior to Visit 1.

Related Conditions & MeSH terms

• Common Wart
• Warts

Intervention

Drug:
• A-101 Topical Solution
A-101 Topical Solution
• A-101 Vehicle Solution
A-101 Vehicle Solution

Locations

Country	Name	City	State
United States	Aclaris Investigational Site	Arlington Heights	Illinois
United States	Aclaris Investigational Site	Austin	Texas
United States	Aclaris Investigational Site	Broomall	Pennsylvania
United States	Aclaris Investigational Site	Fort Washington	Pennsylvania
United States	Aclaris Investigational Site	Fountain Inn	South Carolina
United States	Aclaris Investigational Site	Fridley	Minnesota
United States	Aclaris Investigational Site	Indianapolis	Indiana
United States	Aclaris Investigational Site	Miami	Florida
United States	Aclaris Investigational Site	New York	New York
United States	Aclaris Investigational Site	Newnan	Georgia
United States	Aclaris Investigational Site	Plainfield	Indiana
United States	Aclaris Investigational Site	Rogers	Arkansas
United States	Aclaris Investigational Site	San Antonio	Texas
United States	Aclaris Investigational Site	San Diego	California
United States	Aclaris Investigational Site	San Diego	California
United States	Aclaris Investigational Site	Scottsdale	Arizona
United States	Aclaris Investigational Site	Warren	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Aclaris Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Physician's Wart Assessment Score From Baseline to Day 57	Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated.; Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length); A visible wart = 3 mm and < 6 mm in maximal diameter (or length); A visible wart = 6 mm in maximal diameter (or length)	Day 57