Clinical trial NCT03691831: A Study of A-101 Topical Solution for the Treatment of Common Warts
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Wart
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-02
Enrollment: 502
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study
Primary purpose: TREATMENT

Brief summary: Phase 3 Study of A-101 Topical Solution 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

Eligibility criteria: 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 ≥ 2 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. 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.
7. 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 the identified common warts or which exposes the subject to an unacceptable risk by study participation.
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 common 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:

   1. Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8 weeks
   2. 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:

   1. Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab); 16 weeks
   2. 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:

   1. LASER, light or other energy-based therapy (e.g., intense pulsed light \[IPL\], photodynamic therapy \[PDT\]); 180 days
   2. Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester\[SADBE\], etc.) 12 weeks
   3. Liquid nitrogen, electrodesiccation, curettage; 60 days
   4. Hydrogen peroxide; 90 days
   5. Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks
   6. Retinoids; 90 days
   7. 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:

   1. Cutaneous malignancy; 180 days
   2. Sunburn; currently
   3. 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.

Primary outcomes:
measure: 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)
timeFrame: Day 60
Secondary outcomes:
measure: 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)
timeFrame: Day 137
measure: 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)
timeFrame: Day 137
measure: 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)
timeFrame: Day 60
measure: Median Time for Subjects to Achieve Clearance (PWA=0) of All Treated Common Warts
timeFrame: Day 137
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Aclaris Investigational Site
state: Arizona
city: Fort Smith
country: United States
facility: Aclaris Investigational Site
state: Arkansas
city: Encinitas
country: United States
facility: Aclaris Investigational Site
state: California
city: San Diego
country: United States
facility: Aclaris Investigational Site
state: California
city: Denver
country: United States
facility: Aclaris Investigational Site
state: Colorado
city: Coral Gables
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Miami
country: United States
facility: Aclaris Investigational Site
state: Florida
city: New Albany
country: United States
facility: Aclaris Investigational Site
state: Indiana
city: Rockville
country: United States
facility: Aclaris Investigational Site
state: Maryland
city: Quincy
country: United States
facility: Aclaris Investigational Site
state: Massachusetts
city: Saint Joseph
country: United States
facility: Aclaris Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Aclaris Investigational Site
state: Nebraska
city: Rochester
country: United States
facility: Aclaris Investigational Site
state: New York
city: Raleigh
country: United States
facility: Aclaris Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Aclaris Investigational Site
state: Ohio
city: Upper Saint Clair
country: United States
facility: Aclaris Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: Aclaris Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: Aclaris Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Aclaris Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Aclaris Investigational Site
state: Texas
city: College Station
country: United States
facility: Aclaris Investigational Site
state: Texas
city: Houston
country: United States
facility: Aclaris Investigational Site
state: Texas
city: Lynchburg
country: United States
facility: Aclaris Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Aclaris Investigational Site
state: Virginia
Study officials:
affiliation: Aclaris Therapeutics
name: Judy Schynder
role: STUDY_DIRECTOR
References: