Clinical trial NCT03278028: A Study of A-101 Topical Solution Administered Twice a Week in Subjects With Common Warts
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Common Wart
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-11
Enrollment: 159
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Physician's Wart Assessment
timeFrame: Day 57
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Aclaris Investigational Site
state: Arizona
city: Fort Smith
country: United States
facility: Aclaris Investigational Site
state: Arkansas
city: Encinitas
country: United States
facility: Aclaris Investigational Site
state: California
city: Los Angeles
country: United States
facility: Aclaris Investigational Site
state: California
city: Denver
country: United States
facility: Aclaris Investigational Site
state: Colorado
city: Omaha
country: United States
facility: Aclaris Investigational Site
state: Nebraska
city: Albuquerque
country: United States
facility: Aclaris Investigational Site
state: New Mexico
city: Rochester
country: United States
facility: Aclaris Investigational Site
state: New York
city: High Point
country: United States
facility: Aclaris Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: Aclaris Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Aclaris Investigational Site
state: Tennessee
city: College Station
country: United States
facility: Aclaris Investigational Site
state: Texas
city: Houston
country: United States
facility: Aclaris Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Aclaris Investigational Site
state: Utah
city: Lynchburg
country: United States
facility: Aclaris Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Aclaris Investigational Site
state: Virginia
Study officials:
affiliation: Aclaris Therapeutics
name: Stuart D Shanler, MD
role: STUDY_DIRECTOR
References: