A Study of A-101 Topical Solution Administered Twice a Week in Subjects With Common Warts



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:8 - Any
Updated:3/31/2019
Start Date:July 13, 2017
End Date:March 1, 2018

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A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts

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 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.

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.
We found this trial at
16
sites
Lynchburg, Virginia 24501
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Albuquerque, New Mexico 87106
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College Station, Texas 77845
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Denver, Colorado 80210
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Encinitas, California 92024
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Encinitas, CA
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Fort Smith, Arkansas 72916
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Fort Smith, AR
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Glendale, Arizona 85308
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High Point, South Carolina 27262
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High Point, SC
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Houston, Texas 77004
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Houston, TX
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Knoxville, Tennessee 37922
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Los Angeles, California 90045
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Los Angeles, CA
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Nashville, Tennessee 37215
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Nashville, TN
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Norfolk, Virginia 23507
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Norfolk, VA
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Omaha, Nebraska 68144
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Omaha, NE
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Rochester, New York 14623
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Rochester, NY
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Salt Lake City, Utah 84117
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Salt Lake City, UT
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