Overview

An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses

Status:
Completed
Trial end date:
2018-11-14
Target enrollment:
0
Participant gender:
All
Summary
This study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with A-101 40%.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Aclaris Therapeutics, Inc.
Treatments:
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

1. Subject can comprehend and is willing to sign an informed consent for participation in
this study.

2. Male or female between the ages of 30 and 75 years old.

3. Subject has 3 eligible Seborrheic Keratoses; 2 target SKs must be on the face, and the
additional 1 target SK must be on the neck or decolletage.

4. Subjects must have had cryosurgery for SK removal within the last 6 months and prior
to first treatment with A-101 Topical Solution.

5. Target and non-target SKs must not have been previously treated.

6. 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 or non-target SK or which exposes the subject to an unacceptable risk by study
participation

Exclusion Criteria:

1. Subject has clinically atypical and /or rapidly growing Seborrheic Keratoses.

2. Subject has current systemic malignancy.

3. Subject would require the use of any topical treatment (e.g., moisturizers,
sunscreens) to any of the target or non-target SKs 12 hours prior to any study visit.

4. 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