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A Study of A-101 Topical Solution Administered Twice a Week 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: NCT03278028
Recruitment Status : Completed
First Posted : September 11, 2017
Results First Posted : March 29, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE August 18, 2017
First Posted Date  ICMJE September 11, 2017
Results First Submitted Date  ICMJE March 7, 2019
Results First Posted Date  ICMJE March 29, 2019
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE July 13, 2017
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
Physician's Wart Assessment [ 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)
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
Physician's Wart Assessment [ Time Frame: Day 134 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of A-101 Topical Solution Administered Twice a Week in Subjects With Common Warts
Official Title  ICMJE A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts
Brief Summary The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.
Detailed Description

The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.

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) twice a week, duration of response in all treated Warts (Target Warts plus Non-Target Warts), and safety of A-101.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Common Wart
Intervention  ICMJE
  • Drug: A-101 Topical Solution
    A-101 Topical Solution
  • Drug: A-101 Vehicle Solution
    A-101 Vehicle Solution
Study Arms  ICMJE
  • Experimental: Active
    A-101 Topical Solutions
    Intervention: Drug: A-101 Topical Solution
  • Placebo Comparator: Vehicle
    Vehicle
    Intervention: Drug: A-101 Vehicle Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2017)
159
Original Estimated Enrollment  ICMJE
 (submitted: September 8, 2017)
120
Actual Study Completion Date  ICMJE March 1, 2018
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.
  • Woman 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 non-pregnant and non-lactating.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03278028
Other Study ID Numbers  ICMJE A-101-WART-203
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aclaris Therapeutics, Inc.
Study Sponsor  ICMJE Aclaris Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stuart D Shanler, MD Aclaris Therapeutics
PRS Account Aclaris Therapeutics, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP