Clinical trial NCT03812510: Safety Study of A-101 Topical Solution for the Treatment of Common Warts
Official title: A Phase 3 Open Label Safety Study of A-101 Topical Solution for the Treatment of Common Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Wart
Keywords: common warts
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-23
Enrollment: 426
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* Subject or legal guardian is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
* Subject must have completed study participation in either A-101-WART-301 or A-101-WART-302.
* Male or female ≥ 1 years old.
* Subject has a clinical diagnosis of common warts (verruca vulgaris).
* Identified warts must have a longest axis of ≤8 mm

Exclusion Criteria:

* Subject has clinically atypical warts.
* Subject is immunocompromised
* Subject has a history of Human Immunodeficiency Virus (HIV) infection.
* Subject has had any Human Papilloma Virus (HPV) vaccine within 6 months prior to Visit 1.
* Subject has used any of the following intralesional therapies within the specified period prior to Visit 1:

  1. Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8 weeks
  2. Anti-metabolite therapy (e.g., bleomycin, 5-fluorouracil); 8 weeks
* Subject has used any of the following systemic therapies within the specified period prior to Visit 1:

  1. Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab); 16 weeks
  2. Glucocorticosteroids (inhaled and intra-nasal steroids are permitted); 28 days
* Subject has used any of the following topical therapies 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. 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 (other than IP from the 301/302 study)
  5. Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks
  6. Retinoids; 90 days
  7. Over-the-counter (OTC) wart therapies and cantharidin; 28 days
* Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in a 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
* Subject has a history of sensitivity to any of the ingredients in the study medications.
* 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.
* Participation in another therapeutic investigational drug/device trial (other than the Aclaris 301 or 302 study) in which administration of an investigational treatment occurred within 30 days prior to Visit 1.
* Subject has an active malignancy.

Primary outcomes:
measure: Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts
timeFrame: Baseline to a maximum of 341 days
Secondary outcomes:
measure: Durability of Response: Median Number of Days All Warts Remain Clear by Treatment Group and Treatment Cycle for Subjects With All Warts Achieving a Status of Clear (PWA=0) (Treatment Cycle 1)
timeFrame: Baseline to a maximum of 207 days
measure: Durability of Response: Median Number of Days All Warts Remain Clear by Treatment Group and Treatment Cycle for Subjects With All Warts Achieving a Status of Clear (PWA=0) (Treatment Cycle 2)
timeFrame: Baseline to a maximum of 248 days
measure: Durability of Response: Median Number of Days All Warts Remain Clear by Treatment Group and Treatment Cycle for Subjects With All Warts Achieving a Status of Clear (PWA=0) (Treatment Cycle 3)
timeFrame: Baseline to a maximum of 290 days
measure: Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 1)
timeFrame: Baseline to a maximum of 207 days
measure: Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 2)
timeFrame: Baseline to a maximum of 248 days
measure: Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 3)
timeFrame: Baseline to a maximum of 290 days
measure: Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 1)
timeFrame: Baseline to a maximum of 207 days
measure: Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 2)
timeFrame: Baseline to a maximum of 248 days
measure: Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 3)
timeFrame: Baseline to a maximum of 290 days
measure: Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 1)
timeFrame: Baseline to a maximum of 207 days
measure: Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 2)
timeFrame: Baseline to a maximum of 248 days
measure: Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 3)
timeFrame: Baseline to a maximum of 290 days
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Aclaris Investigational Site
state: Alabama
city: Glendale
country: United States
facility: Aclaris Investigational Site
state: Arizona
city: Fort Smith
country: United States
facility: Aclaris Investigational Site
state: Arkansas
city: Hot Springs
country: United States
facility: Aclaris Investigational Site
state: Arkansas
city: Encinitas
country: United States
facility: Aclaris Investigational Site
state: California
city: Fountain Valley
country: United States
facility: Aclaris Investigational Site
state: California
city: San Diego
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: Aventura
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Miami
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Miami
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Ocala
country: United States
facility: Aclaris Investigational Site
state: Florida
city: Newnan
country: United States
facility: Aclaris Investigational Site
state: Georgia
city: Indianapolis
country: United States
facility: Aclaris Investigational Site
state: Indiana
city: New Albany
country: United States
facility: Aclaris Investigational Site
state: Indiana
city: Louisville
country: United States
facility: Aclaris Investigational Site
state: Kentucky
city: Rockville
country: United States
facility: Aclaris Investigational Site
state: Maryland
city: Fridley
country: United States
facility: Aclaris Investigational Site
state: Minnesota
city: Saint Joseph
country: United States
facility: Aclaris Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Aclaris Investigational Sites
state: Nebraska
city: Las Vegas
country: United States
facility: Aclaris Investigational Site
state: Nevada
city: Verona
country: United States
facility: Aclaris Investigational Site
state: New Jersey
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: Bexley
country: United States
facility: Aclaris Investigational Site
state: Ohio
city: Broomall
country: United States
facility: Aclaris Invesgational Site
state: Pennsylvania
city: Fort Washington
country: United States
facility: Aclaris Investigational Site
state: Pennsylvania
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: Charleston
country: United States
facility: Aclaris Investigational Site
state: South Carolina
city: Fountain Inn
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: Austin
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: Pflugerville
country: United States
facility: Aclaris Investigational Site
state: Texas
city: San Antonio
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
city: Norfolk
country: United States
facility: Aclaris Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Aclaris Investigational Site
state: Washington
Study officials:
affiliation: Aclaris Therapeutics
name: David Gordon, MB, ChB
role: STUDY_DIRECTOR
References: