A Study of A-101 Solution in Subjects With Common Warts.

NCT02669862 | Completed Phase 2 Results

• 1 other identifier: A-101-WART-201
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups.

Conditions

Common Warts

Outcome Measures

Primary Outcomes (1)

• Efficacy Based on Mean Change in Physician Wart Assessment Over Time

  The primary effectiveness will consist of the mean change from Visit 2 to Visit 10 in Physician Wart Assessment (PWA) performed using Analysis of Covariance (ANCOVA) with Visit 2 PWA as the covariate. Physician Wart Analysis is a measurement scale from 0 to 3 that evaluates the wart with 0 being clear and 3 being clinically diagnosable wart that is raised, with an obviously rough surface.

  57 Days

Secondary Outcomes (2)

• Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13

  visit 10 to visit 13

• PWA Responder

  Day 57

Study Arms (3)

A-101 Solution 40

EXPERIMENTAL

A-101 Solution 40% administered once per week

Drug: A-101 Solution 40

A-101 Solution 45

EXPERIMENTAL

A-101 Solution 45% administered once per week

Drug: A-101 Solution 45

Vehicle Solution

PLACEBO COMPARATOR

Vehicle Solution administered once per week

Drug: Vehicle Solution

Interventions

A-101 Solution 40 DRUG

A-101 Solution 40

A-101 Solution 45 DRUG

A-101 Solution 45

Vehicle Solution DRUG

Vehicle Solution

Eligibility Criteria

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

You may qualify if:

• Subject is at least 18 years of age
• Subject has a clinical diagnosis of common warts
• Subject has 1 appropriate Target Wart as defined below, on the trunk or extremities:
• Have a longest axis that is 3mm to 10mm
• Have a thickness ≤3mm
• Be a discrete lesion
• Be, when centered in the circular cutout of the provided template, the only common wart present
• Not be periungual, subungual, genital or anal
• Not be covered with hair which, in the Investigator's opinion, would interfere with the study medication treatments or the study evaluations Not be in an area that may be occluded (by clothing, footwear or within a skin fold).
• The Target Wart has a Physician Wart Assessment (PWA) ≥2
• If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective 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 put the subject at undue risk by study participation or interfere with the study conduct or evaluations
• Subject is willing and able to follow all study instructions and to attend all study visits
• Subject is able to comprehend and willing to sign an Informed Consent Form.

You may not qualify if:

• Subject has clinically atypical warts on the trunk or extremities
• Subject is immune compromised (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 enrollment
• Subject has used any of the following intralesional therapies within the specified period prior to enrollment to the Target Wart:
• Immunotherapy (Candida antigen, mumps antigen, Trichophyton antigen);
• Anti-metabolite therapy (bleomycin, 5-fluorouracil)
• Subject has used any of the following systemic therapies within the specified period prior to enrollment:
• Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab);
• Glucocortico-steroids (inhaled and intra-nasal steroids are permitted);
• Subject has used any of the following topical therapies within the specified period prior to enrollment on, or in a proximity to the Target Wart, which in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations:
• \- LASER (pulsed-dye laser), light (intense pulsed light, photo-dynamic therapy, other energy based therapy); Immuno-therapy ( imiquimod, squaric acid dibutyl ester, etc.); Anti-metabolite therapy (5-fluorouracil); Retinoids; Liquid nitrogen, electrodesiccation, curettage; Over-the-counter wart therapies
• Subject has had any of the following within the specified period prior to enrollment on, or in a proximity to the target lesion, which in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations:
• A cutaneous malignancy;
• A pre-malignancy (actinic keratosis)

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (1)

Aclaris Therapeutics, Inc.

Wayne, Pennsylvania, 19087, 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: Judy Schnyder, Senior Director of Clinical Operations
• Organization: Aclaris Therapeutics, Inc.

jschnyder@aclaristx.com

484-329-2144

Study Officials

• Stuart D Shanler, MD

  Aclaris Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: January 28, 2016
• First Posted: February 1, 2016
• Study Start: December 21, 2015
• Primary Completion: September 16, 2016
• Study Completion: September 16, 2016
• Last Updated: December 7, 2018
• Results First Posted: December 7, 2018

Record last verified: 2018-11

Locations

US (1)