Safety Study of A-101 Topical Solution for the Treatment of Common Warts
NCT ID: NCT03812510
Last Updated: 2020-11-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
426 participants
INTERVENTIONAL
2019-02-07
2019-12-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A-101
Topical Solution
A-101
hydrogen peroxide topical solution 45%
Interventions
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A-101
hydrogen peroxide topical solution 45%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
1 Year
ALL
No
Sponsors
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Aclaris Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Gordon, MB, ChB
Role: STUDY_DIRECTOR
Aclaris Therapeutics
Locations
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Aclaris Investigational Site
Mobile, Alabama, United States
Aclaris Investigational Site
Glendale, Arizona, United States
Aclaris Investigational Site
Fort Smith, Arkansas, United States
Aclaris Investigational Site
Hot Springs, Arkansas, United States
Aclaris Investigational Site
Encinitas, California, United States
Aclaris Investigational Site
Fountain Valley, California, United States
Aclaris Investigational Site
San Diego, California, United States
Aclaris Investigational Site
San Diego, California, United States
Aclaris Investigational Site
Denver, Colorado, United States
Aclaris Investigational Site
Aventura, Florida, United States
Aclaris Investigational Site
Jacksonville, Florida, United States
Aclaris Investigational Site
Miami, Florida, United States
Aclaris Investigational Site
Miami, Florida, United States
Aclaris Investigational Site
Ocala, Florida, United States
Aclaris Investigational Site
Newnan, Georgia, United States
Aclaris Investigational Site
Indianapolis, Indiana, United States
Aclaris Investigational Site
New Albany, Indiana, United States
Aclaris Investigational Site
Louisville, Kentucky, United States
Aclaris Investigational Site
Rockville, Maryland, United States
Aclaris Investigational Site
Fridley, Minnesota, United States
Aclaris Investigational Site
Saint Joseph, Missouri, United States
Aclaris Investigational Sites
Omaha, Nebraska, United States
Aclaris Investigational Site
Las Vegas, Nevada, United States
Aclaris Investigational Site
Verona, New Jersey, United States
Aclaris Investigational Site
Rochester, New York, United States
Aclaris Investigational Site
Raleigh, North Carolina, United States
Aclaris Investigational Site
Beachwood, Ohio, United States
Aclaris Investigational Site
Bexley, Ohio, United States
Aclaris Invesgational Site
Broomall, Pennsylvania, United States
Aclaris Investigational Site
Fort Washington, Pennsylvania, United States
Aclaris Investigational Site
Upper Saint Clair, Pennsylvania, United States
Aclaris Investigational Site
Anderson, South Carolina, United States
Aclaris Investigational Site
Charleston, South Carolina, United States
Aclaris Investigational Site
Fountain Inn, South Carolina, United States
Aclaris Investigational Site
Knoxville, Tennessee, United States
Aclaris Investigational Site
Nashville, Tennessee, United States
Aclaris Investigational Site
Arlington, Texas, United States
Aclaris Investigational Site
Austin, Texas, United States
Aclaris Investigational Site
College Station, Texas, United States
Aclaris Investigational Site
Houston, Texas, United States
Aclaris Investigational Site
Pflugerville, Texas, United States
Aclaris Investigational Site
San Antonio, Texas, United States
Aclaris Investigational Site
Lynchburg, Virginia, United States
Aclaris Investigational Site
Norfolk, Virginia, United States
Aclaris Investigational Site
Norfolk, Virginia, United States
Aclaris Investigational Site
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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A-101-WART-303
Identifier Type: -
Identifier Source: org_study_id