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

NCT03278028 | Completed Phase 2 Results FDA Drug

• 1 other identifier: A-101-WART-203
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Common Wart

Outcome Measures

Primary Outcomes (1)

• Physician's Wart Assessment

  Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated. 1. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length) 2. A visible wart ≥ 3 mm and \< 6 mm in maximal diameter (or length) 3. A visible wart ≥ 6 mm in maximal diameter (or length)

  Day 57

Study Arms (2)

Active

EXPERIMENTAL

A-101 Topical Solutions

Drug: A-101 Topical Solution

Vehicle

PLACEBO COMPARATOR

Vehicle

Drug: A-101 Vehicle Solution

Interventions

A-101 Topical Solution DRUG

A-101 Topical Solution

Active

A-101 Vehicle Solution DRUG

A-101 Vehicle Solution

Vehicle

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (16)

Aclaris Investigational Site

Glendale, Arizona, 85308, United States

Location

Aclaris Investigational Site

Fort Smith, Arkansas, 72916, United States

Location

Aclaris Investigational Site

Encinitas, California, 92024, United States

Location

Aclaris Investigational Site

Los Angeles, California, 90045, United States

Location

Aclaris Investigational Site

Denver, Colorado, 80210, United States

Location

Aclaris Investigational Site

Omaha, Nebraska, 68144, United States

Location

Aclaris Investigational Site

Albuquerque, New Mexico, 87106, United States

Location

Aclaris Investigational Site

Rochester, New York, 14623, United States

Location

Aclaris Investigational Site

High Point, South Carolina, 27262, United States

Location

Aclaris Investigational Site

Knoxville, Tennessee, 37922, United States

Location

Aclaris Investigational Site

Nashville, Tennessee, 37215, United States

Location

Aclaris Investigational Site

College Station, Texas, 77845, United States

Location

Aclaris Investigational Site

Houston, Texas, 77004, United States

Location

Aclaris Investigational Site

Salt Lake City, Utah, 84117, United States

Location

Aclaris Investigational Site

Lynchburg, Virginia, 24501, United States

Location

Aclaris Investigational Site

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Executive Director, Clinical Operations
• Organization: Aclaris Therapeutics

jschnyder@aclaristx.com

+1(484) 329-2144

Study Officials

• Stuart D Shanler, MD

  Aclaris Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: September 11, 2017
• Study Start: July 13, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 9, 2019
• Results First Posted: March 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)