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

A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Solution in Subjects With Common Warts.

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

Study Overview

• Status: Completed
• Conditions: Common Warts
• Intervention / Treatment: Drug: A-101 Solution 40; Drug: A-101 Solution 45; Drug: Vehicle Solution

Detailed Description

This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups. During Visit 1, the Investigator will identify 1 eligible common wart on the trunk or extremities on each subject. The wart will be treated up to a maximum of 8 times at 1 week intervals during the study.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Wayne, Pennsylvania, United States, 19087
      • Aclaris Therapeutics, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is at least 18 years of age
2. Subject has a clinical diagnosis of common warts

3. 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).
4. The Target Wart has a Physician Wart Assessment (PWA) ≥2
5. 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
6. Subject is non-pregnant and non-lactating
7. 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
8. Subject is willing and able to follow all study instructions and to attend all study visits
9. Subject is able to comprehend and willing to sign an Informed Consent Form.

Exclusion Criteria:

1. Subject has clinically atypical warts on the trunk or extremities
2. Subject is immune compromised (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 1 year prior to enrollment

5. 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)

6. 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);

7. 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

8. 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)
9. Subject has a history of sensitivity to any of the ingredients in the study medications
10. Subject has any current skin disease (psoriasis, atopic dermatitis, eczema, sun damage, etc.), skin condition (sunburn, open wounds) or other disease or condition (uncontrolled diabetes) which, in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
11. Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A-101 Solution 40; A-101 Solution 40% administered once per week	Drug: A-101 Solution 40
Experimental: A-101 Solution 45; A-101 Solution 45% administered once per week	Drug: A-101 Solution 45
Placebo Comparator: Vehicle Solution; Vehicle Solution administered once per week	Drug: Vehicle Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13	Percentage of subjects whose target wart was clear at Visit 10 and who remained clear at Visit 13 for active treatment groups	visit 10 to visit 13
PWA Responder	The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10.	Day 57

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 21, 2015
• Primary Completion (Actual): September 16, 2016
• Study Completion (Actual): September 16, 2016

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 1, 2016

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

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-201