A Phase2 of A-101 Topical Solution in Subjects With Common Warts
NCT ID: NCT03210337
Last Updated: 2019-05-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
157 participants
INTERVENTIONAL
2017-08-01
2018-03-16
Brief Summary
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Detailed Description
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The secondary objectives of this study are to evaluate the clinical effect of A-101 when applied to all treated warts (Target Warts plus Non-Target Warts), duration of response in all treated warts (Target Warts plus Non-Target Warts), and Safety of A-101.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active
A-101 Topical Solution
A-101 Topical Solution
A-101 Topical Solution
Vehicle
Vehicle
A-101 Vehicle Solution
A-101 Vehicle Solution
Interventions
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A-101 Topical Solution
A-101 Topical Solution
A-101 Vehicle Solution
A-101 Vehicle Solution
Eligibility Criteria
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Inclusion Criteria
* Male or female ≥ 8 years old.
* Subject has a clinical diagnosis of common warts.
* Subject 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.
* Women of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.
* 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 any Target and Non-Target Warts or which exposes the subject to an unacceptable risk by study participation.
* Subject is willing and able to follow all study instructions and to attend all study visits.
Exclusion Criteria
* Subject is immunocompromised (e.g, due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
* Subject has a history of Human Immunodeficiency Virus (HIV) infection
* Subject has had any Human Papilloma Virus (HPV) vaccine within 1 year prior to Visit 1
* Subject has a history of sensitivity to any of the ingredients in the study medications.
* Subject has any current skin 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 trial in which administration of an investigational study medication occurred with 30 days prior to Visit 1.
8 Years
ALL
No
Sponsors
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Aclaris Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Aclaris Investigational Site
Scottsdale, Arizona, United States
Aclaris Investigational Site
Rogers, Arkansas, United States
Aclaris Investigational Site
San Diego, California, United States
Aclaris Investigational Site
San Diego, California, United States
Aclaris Investigational Site
Miami, Florida, United States
Aclaris Investigational Site
Newnan, Georgia, United States
Aclaris Investigational Site
Arlington Heights, Illinois, United States
Aclaris Investigational Site
Indianapolis, Indiana, United States
Aclaris Investigational Site
Plainfield, Indiana, United States
Aclaris Investigational Site
Warren, Michigan, United States
Aclaris Investigational Site
Fridley, Minnesota, United States
Aclaris Investigational Site
New York, New York, United States
Aclaris Investigational Site
Broomall, Pennsylvania, United States
Aclaris Investigational Site
Fort Washington, Pennsylvania, United States
Aclaris Investigational Site
Fountain Inn, South Carolina, United States
Aclaris Investigational Site
Austin, Texas, United States
Aclaris Investigational Site
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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A-101-WART-202
Identifier Type: -
Identifier Source: org_study_id
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