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

Primary Purpose

Common Wart

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
A-101 Topical Solution
A-101 Vehicle Solution
Sponsored by
Aclaris Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Wart

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site
  • Aclaris Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Vehicle

Arm Description

A-101 Topical Solution

Vehicle

Outcomes

Primary Outcome Measures

Mean Change in Physician's Wart Assessment Score From Baseline to Day 57
Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length) A visible wart ≥ 3 mm and < 6 mm in maximal diameter (or length) A visible wart ≥ 6 mm in maximal diameter (or length)

Secondary Outcome Measures

Full Information

First Posted
June 2, 2017
Last Updated
April 11, 2019
Sponsor
Aclaris Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03210337
Brief Title
A Phase2 of A-101 Topical Solution in Subjects With Common Warts
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
March 16, 2018 (Actual)
Study Completion Date
March 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aclaris Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Wart

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
A-101 Topical Solution
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
A-101 Topical Solution
Intervention Description
A-101 Topical Solution
Intervention Type
Drug
Intervention Name(s)
A-101 Vehicle Solution
Intervention Description
A-101 Vehicle Solution
Primary Outcome Measure Information:
Title
Mean Change in Physician's Wart Assessment Score From Baseline to Day 57
Description
Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length) A visible wart ≥ 3 mm and < 6 mm in maximal diameter (or length) A visible wart ≥ 6 mm in maximal diameter (or length)
Time Frame
Day 57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Aclaris Investigational Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Aclaris Investigational Site
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Aclaris Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Aclaris Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Aclaris Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Aclaris Investigational Site
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Aclaris Investigational Site
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Aclaris Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Aclaris Investigational Site
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Aclaris Investigational Site
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Aclaris Investigational Site
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Aclaris Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10155
Country
United States
Facility Name
Aclaris Investigational Site
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
Aclaris Investigational Site
City
Fort Washington
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
Facility Name
Aclaris Investigational Site
City
Fountain Inn
State/Province
South Carolina
ZIP/Postal Code
29644
Country
United States
Facility Name
Aclaris Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Aclaris Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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