Clinical Trial: Study of A-101 for the Treatment of Seborrheic Keratosis

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

Official Title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Dose-Response Profile of A-101 Topical Solution in Subjects With Seborrheic Keratosis of the Fa

Brief Summary: The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of A-101 versus a vehicle control in the treatment of seborrheic keratosis.

Detailed Summary: The main objective of this study is to evaluate the dose-response relationship of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied to SK target lesions on the face. A further objective is to evaluate the safety and efficacy of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied topically up to 2 times to SK target lesions on the face.
Sponsor: Aclaris Therapeutics, Inc.

Current Primary Outcome: Physician's Lesion Assessment (PLA) Score [ Time Frame: Day 106 ]

Combined mean change in PLA Score at End of Study


Original Primary Outcome: Same as current

Current Secondary Outcome: PLA Responder Analysis [ Time Frame: Day 106 ]

Responder analysis of PLA scores of 0/1


Original Secondary Outcome: Same as current

Information By: Aclaris Therapeutics, Inc.

Dates:
Date Received: October 3, 2014
Date Started: October 2014
Date Completion:
Last Updated: March 12, 2015
Last Verified: March 2015