Clinical Trial: Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Vehicle-Controlled, Within-Subject, Comparison Study of the Safety, Tolerability, And Effectiveness of A-101 Topical Solution in Subjects With Seborrh

Brief Summary: Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects.

Detailed Summary: The main objective of this study is to evaluate the safety, effectiveness and tolerability of three concentrations of A-101 25%, 32.5%, and 40%, when applied to individual seborrheic keratosis target lesions on the back compared with a matching A-101 vehicle.
Sponsor: Aclaris Therapeutics, Inc.

Current Primary Outcome: Physician Lesion Assessment Scale [ Time Frame: Day 78 ]

Physician's subjective assessment of the condition of the lesion


Original Primary Outcome: Same as current

Current Secondary Outcome: Subject's Self Assessment Scale [ Time Frame: Day 78 ]

Subjects assessment of the condition of their lesions


Original Secondary Outcome: Same as current

Information By: Aclaris Therapeutics, Inc.

Dates:
Date Received: November 6, 2013
Date Started: November 2013
Date Completion:
Last Updated: March 10, 2014
Last Verified: March 2014