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A Phase2 of A-101 Topical Solution in Subjects With Common Warts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03210337
Recruitment Status : Completed
First Posted : July 6, 2017
Results First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Brief Summary:
The primary objective of this study is to evaluate the effectiveness of A-101 compared to vehicle when applied to 1 common target wart on the trunk or extremities.

Condition or disease Intervention/treatment Phase
Common Wart Drug: A-101 Topical Solution Drug: A-101 Vehicle Solution Phase 2

Detailed Description:

The primary objective of this study is to evaluate the effectiveness of A-101 compared to vehicle when applied to 1 common target wart on the trunk or extremities.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Once a Week in Subjects With Common Warts
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : March 16, 2018
Actual Study Completion Date : March 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Experimental: Active
A-101 Topical Solution
Drug: A-101 Topical Solution
A-101 Topical Solution

Placebo Comparator: Vehicle
Vehicle
Drug: A-101 Vehicle Solution
A-101 Vehicle Solution




Primary Outcome Measures :
  1. Mean Change in Physician's Wart Assessment Score From Baseline to Day 57 [ Time Frame: Day 57 ]

    Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated.

    1. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length)
    2. A visible wart ≥ 3 mm and < 6 mm in maximal diameter (or length)
    3. A visible wart ≥ 6 mm in maximal diameter (or length)



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
  • 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 has clinically atypical warts on the trunk or extremities.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210337


Locations
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United States, Arizona
Aclaris Investigational Site
Scottsdale, Arizona, United States, 85225
United States, Arkansas
Aclaris Investigational Site
Rogers, Arkansas, United States, 72758
United States, California
Aclaris Investigational Site
San Diego, California, United States, 92103
Aclaris Investigational Site
San Diego, California, United States, 92123
United States, Florida
Aclaris Investigational Site
Miami, Florida, United States, 33137
United States, Georgia
Aclaris Investigational Site
Newnan, Georgia, United States, 30263
United States, Illinois
Aclaris Investigational Site
Arlington Heights, Illinois, United States, 60005
United States, Indiana
Aclaris Investigational Site
Indianapolis, Indiana, United States, 46256
Aclaris Investigational Site
Plainfield, Indiana, United States, 46168
United States, Michigan
Aclaris Investigational Site
Warren, Michigan, United States, 48088
United States, Minnesota
Aclaris Investigational Site
Fridley, Minnesota, United States, 55432
United States, New York
Aclaris Investigational Site
New York, New York, United States, 10155
United States, Pennsylvania
Aclaris Investigational Site
Broomall, Pennsylvania, United States, 19008
Aclaris Investigational Site
Fort Washington, Pennsylvania, United States, 19034
United States, South Carolina
Aclaris Investigational Site
Fountain Inn, South Carolina, United States, 29644
United States, Texas
Aclaris Investigational Site
Austin, Texas, United States, 78759
Aclaris Investigational Site
San Antonio, Texas, United States, 78213
Sponsors and Collaborators
Aclaris Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Aclaris Therapeutics, Inc.:
Study Protocol  [PDF] December 5, 2017
Statistical Analysis Plan  [PDF] December 1, 2017


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Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03210337     History of Changes
Other Study ID Numbers: A-101-WART-202
First Posted: July 6, 2017    Key Record Dates
Results First Posted: May 1, 2019
Last Update Posted: May 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Pharmaceutical Solutions