Status:
COMPLETED
An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses
Lead Sponsor:
Aclaris Therapeutics, Inc.
Conditions:
Seborrheic Keratosis
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief Summary
This study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with A-101 40%.
Eligibility Criteria
Inclusion
- Subject can comprehend and is willing to sign an informed consent for participation in this study.
- Male or female between the ages of 30 and 75 years old.
- 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.
- Subjects must have had cryosurgery for SK removal within the last 6 months and prior to first treatment with A-101 Topical Solution.
- Target and non-target SKs must not have been previously treated.
- 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
- Subject has clinically atypical and /or rapidly growing Seborrheic Keratoses.
- Subject has current systemic malignancy.
- 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.
- 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
Key Trial Info
Start Date :
March 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2018
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03487588
Start Date
March 21 2018
End Date
November 14 2018
Last Update
October 2 2019
Active Locations (3)
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1
Aclaris Investigational Site
Fort Washington, Pennsylvania, United States, 19034
2
Aclaris Investigational Site
Knoxville, Tennessee, United States, 37922
3
Aclaris Investigational Site
Austin, Texas, United States, 78759