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

Aclaris Therapeutics

Status and phase: Completed; Phase 2

Conditions: Common Wart

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03278028

A-101-WART-203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 159 patients

Sex: All

Ages: 8+ years old

Volunteers: No 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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159 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

A-101 Topical Solutions

Treatment:

Drug: A-101 Topical Solution

Vehicle

Placebo Comparator group

Description:

Vehicle

Treatment:

Drug: A-101 Vehicle Solution