NCT03148691

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

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 Seborrheic Keratosis Lesions on the Trunk, Extremities, and Face

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Aclaris Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Seborrheic Keratosis

Interventions

Type	Name	Description
DRUG	A-101	Topical Solution

Timeline

• Start date: 2017-05-17
• Primary completion: 2018-02-28
• Completion: 2018-04-03
• First posted: 2017-05-11
• Last updated: 2019-05-06
• Results posted: 2019-05-06

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study