Clinical Trial: Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis

Study Status: Completed
Recruit Status: Unknown status
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.

Brief Summary: The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.

Detailed Summary:

The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.

Each subject will have 4 target lesions on the trunk/extremities.

A further objective is to evaluate the safety and efficacy of two concentrations of A-101 solution and its matching vehicle when applied to SK target lesions on the trunk/extremities.


Sponsor: Aclaris Therapeutics, Inc.

Current Primary Outcome: Physician's Lesion Assessment [ Time Frame: 16 weeks ]

Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study


Original Primary Outcome: Same as current

Current Secondary Outcome: Physician's Lesion Assessment [ Time Frame: 16 weeks ]

Change from baseline PLA will be calculated for each lesion first, then per-subject mean changes from baseline will be calculated.


Original Secondary Outcome: Same as current

Information By: Aclaris Therapeutics, Inc.

Dates:
Date Received: June 6, 2014
Date Started: June 2014
Date Completion: December 2014
Last Updated: October 7, 2014
Last Verified: June 2014