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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03278028
Other study ID # A-101-WART-203
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 13, 2017
Est. completion date March 1, 2018

Study information

Verified date April 2019
Source Aclaris Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 159
Est. completion date March 1, 2018
Est. primary completion date March 1, 2018
Accepts healthy volunteers No
Gender All
Age group 8 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
A-101 Topical Solution
A-101 Topical Solution
A-101 Vehicle Solution
A-101 Vehicle Solution

Locations

Country Name City State
United States Aclaris Investigational Site Albuquerque New Mexico
United States Aclaris Investigational Site College Station Texas
United States Aclaris Investigational Site Denver Colorado
United States Aclaris Investigational Site Encinitas California
United States Aclaris Investigational Site Fort Smith Arkansas
United States Aclaris Investigational Site Glendale Arizona
United States Aclaris Investigational Site High Point South Carolina
United States Aclaris Investigational Site Houston Texas
United States Aclaris Investigational Site Knoxville Tennessee
United States Aclaris Investigational Site Los Angeles California
United States Aclaris Investigational Site Lynchburg Virginia
United States Aclaris Investigational Site Nashville Tennessee
United States Aclaris Investigational Site Norfolk Virginia
United States Aclaris Investigational Site Omaha Nebraska
United States Aclaris Investigational Site Rochester New York
United States Aclaris Investigational Site Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Aclaris Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physician's Wart Assessment 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)
Day 57
See also
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Completed NCT03210337 - A Phase2 of A-101 Topical Solution in Subjects With Common Warts Phase 2
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