Overview

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

Status:
Completed
Trial end date:
2018-03-16
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Aclaris Therapeutics, Inc.
Treatments:
Pharmaceutical Solutions
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.