A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Safety and Effectiveness of A-101 Solution 40% in Subjects With Seborrheic Keratosis on the Trunk, Extremities and Face.
Phase of Trial: Phase III
Latest Information Update: 03 Aug 2017
At a glance
- Drugs Hydrogen peroxide (Primary)
- Indications Seborrhoeic keratosis
- Focus Therapeutic Use
- Sponsors Aclaris Therapeutics
- 03 Aug 2017 According to an Aclaris Therapeutics media release, base on the results of this and other study (CTP-700257107). the comapny has submitted a Marketing Authorization Application (MAA) with the Medicines Product Agency (MPA) in Sweden for A-101 40% Topical Solution for the treatment of seborrheic keratosis.
- 09 May 2017 According to an Aclaris Therapeutics media release, NDA for A-101 40% for the topical treatment of SK has been accepted by the FDA for review, based on the data from three phase III trials (see profile 257107 and 267671).The company also plans to submit a marketing authorization application (MAA) for A-101 40% for the treatment of SK in the European Union in the second half of 2017.
- 27 Feb 2017 According to an Aclaris Therapeutics media release, the company has submitted an NDA to the US FDA for A-101 40% topical solution (A-101) as a treatment for seborrheic keratosis based on the results of this and another phase III trial (CT profile 700257107).
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History