Study of A-101 Topical Solution for the Treatment of Common Warts

Phase 3

Completed

• Conditions: Common Wart
• Interventions: Other: vehicle; Drug: A-101

• Registration Number: NCT03687372
• Lead Sponsor: Aclaris Therapeutics, Inc.

Brief Summary

A Phase 3 Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

Detailed Description

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

Study Timeline

• Study Start: 2018-09-17
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-27
• Primary Completion: 2019-06-20
• Study Completion: 2019-09-06
• Results First Submitted: 2020-08-18
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-11
• Last Update Submitted: 2020-09-11
• Results First Posted: 2020-10-05
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

Inclusion Criteria

1. Subject or legal guardian is able to comprehend and is willing to sign an informed consent/assent for participation in this study.

2. Male or female ≥ 1 years old.

3. Subject has a clinical diagnosis of common warts (verruca vulgaris).

4. Subject has at least 1 and up to 6 clearly identifiable common warts located on the trunk or extremities that meet the requirements as defined below:

   1. Have a longest axis that is ≥3 and ≤8 mm and have a thickness of ≤3mm
   2. Be a discrete lesion, i.e. each wart meeting the entry criteria is clearly separated from other warts.
   3. Be present for at least 4 weeks
   4. Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
   5. Not be in an intertriginous fold
   6. Periungual, subungual, genital, anal, mosaic, plantar, flat and filiform warts are excluded from treatment and evaluation. If a subject has these types of warts, but also has warts that meet the inclusion criteria, the subject will NOT be excluded from the study.

5. Each common wart identified for treatment must have a PWA ≥ 2.

6. Subject's chemistry and complete blood count results are within normal limits.

7. Subject is in good general health and free of any known disease state or physical condition.

8. Subject is willing and able to follow all study instructions and to attend all study visits.

9. Subject must be the only individual in a household participating in the study.

Exclusion Criteria

1. Subject has clinically atypical warts.

2. Subject is immunocompromised (e.g., 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 6 months prior to Visit 1.

5. Subject has used any of the following intralesional therapies within the specified period prior to Visit 2:

   • Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8 weeks
   • Anti-metabolite therapy (e.g., bleomycin, 5-fluorouracil); 8 weeks

6. Subject has used any of the following systemic therapies within the specified period prior to Visit 2:

   • Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab); 16 weeks
   • Glucocorticosteroids (inhaled and intra-nasal steroids are permitted); 28 days

7. Subject has used any of the following topical therapies within the specified period prior to Visit 2 on, or in the proximity to any of the common warts identified for treatment, that in the investigator's opinion interferes with the study medication treatment or the study assessments:

   • LASER, light or other energy-based therapy (e.g., intense pulsed light [IPL], photodynamic therapy [PDT]); 180 days
   • Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester[SADBE], etc.) 12 weeks
   • Liquid nitrogen, electrodesiccation, curettage; 60 days
   • Hydrogen peroxide; 90 days
   • Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks
   • Retinoids; 90 days
   • Over-the-counter (OTC) wart therapies and cantharidin; 28 days

8. Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in the proximity to any of the common warts identified for treatment that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:

   • Cutaneous malignancy; 180 days
   • Sunburn; currently
   • Pre-malignancy (e.g., actinic keratosis); currently

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

10. Subject has any current skin or systemic 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.

11. Participation in another therapeutic investigational drug/device trial in which administration of an investigational treatment occurred with 30 days prior to Visit 1.

12. Subject has an active malignancy.

13. Subjects is viewed by the Principal Investigator as not being able to complete the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	vehicle	topical solution
A-101	A-101	topical solution

Primary Outcome Measures

Name	Time	Method
The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60)	Day 60	The primary efficacy endpoint is the number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 10 (Day 60).; Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.

Secondary Outcome Measures

Name	Time	Method
Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale Between Active and Vehicle That Are Clear (PWA=0) at Visit 13 (Day 137)	Day 137	Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale Between Active and Vehicle That Are Clear (PWA=0) at Day 137.; Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.
Median Time for Subjects to Achieve Clearance (PWA=0) of All Treated Common Warts	Day 137	Comparison between Active (A-101 45%) and Vehicle with respect to the median time to achieve onset of clearance (PWA=0) for all treated warts at Day 137.; Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.
Number of Subjects With Complete Clearance of All Treated Common Warts Between Active and Vehicle on the Physician Wart Assessment (PWA) Scale (PWA=0) at Visit 13 (Day 137)	Day 137	Number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 13 (Day 137).; Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.
Number of Subjects With a Single Wart at Baseline Whose Wart Was Clear on the PWA Scale Between Active and Vehicle Group (PWA=0) at Visit 10 (Day 60)	Day 60	Comparison between Active (A-101 45%) and Vehicle of subjects with a single wart at baseline, whose wart is clear (PWA=0) at Day 60.; Clearance of the single wart at baseline will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.

Trial Locations

Locations (2)

Aclaris Investigational site; 🇺🇸 San Diego, California, United States

Aclaris Investigational Site; 🇺🇸 Spokane, Washington, United States