A Study of A-101 Topical Solution Administered Twice a Week in Subjects With Common Warts

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

The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.

Study Overview

• Status: Completed
• Conditions: Common Wart
• Intervention / Treatment: Drug: A-101 Topical Solution; Drug: A-101 Vehicle Solution

Detailed Description

The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.

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) twice a week, duration of response in all treated Warts (Target Warts plus Non-Target Warts), and safety of A-101.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Aclaris Investigational Site
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Aclaris Investigational Site
  • California
    • Encinitas, California, United States, 92024
      • Aclaris Investigational Site
    • Los Angeles, California, United States, 90045
      • Aclaris Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80210
      • Aclaris Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Aclaris Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Aclaris Investigational Site
  • New York
    • Rochester, New York, United States, 14623
      • Aclaris Investigational Site
  • South Carolina
    • High Point, South Carolina, United States, 27262
      • Aclaris Investigational Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Aclaris Investigational Site
    • Nashville, Tennessee, United States, 37215
      • Aclaris Investigational Site
  • Texas
    • College Station, Texas, United States, 77845
      • Aclaris Investigational Site
    • Houston, Texas, United States, 77004
      • Aclaris Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Aclaris Investigational Site
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Aclaris Investigational Site
    • Norfolk, Virginia, United States, 23507
      • Aclaris Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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.
• Woman 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 non-pregnant and non-lactating.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Drug: A-101 Vehicle Solution; A-101 Vehicle Solution
Experimental: Active; A-101 Topical Solutions	Drug: A-101 Topical Solution; A-101 Topical Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician's Wart Assessment	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

Collaborators and Investigators

• Sponsor: Aclaris Therapeutics, Inc.
• Investigators: Study Director: Stuart D Shanler, MD, Aclaris Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: August 18, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Pharmaceutical Solutions
• Other Study ID Numbers: A-101-WART-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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