Clinical Trial: A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Safety and Effectiveness of A-101(Hydrogen Peroxide) Topical Solution in Subjects With Seborrh

Brief Summary: The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face.

Detailed Summary:

The primary objective of this study is to evaluate the safety and effectiveness of 2 concentrations of A-101 compared to Vehicle for the treatment of 4 seborrheic keratosis (SK) Target Lesions on the trunk, extremities and face.

The secondary objectives of this study include duration of response of A-101. During the study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face. For each subject, at least 1 SK Target Lesion must be on the face and at least 1 Target Lesion must be on the trunk or extremities. The Target Lesions will be treated at a maximum of two treatment visits.

Sponsor: Aclaris Therapeutics, Inc.

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Aclaris Therapeutics, Inc.

Dates:
Date Received: May 9, 2017
Date Started: May 15, 2017
Date Completion: March 31, 2018
Last Updated: May 9, 2017
Last Verified: May 2017