An Open-Label Study of the Safety of A-101 Solution 40% in Subjects With Seborrheic Keratosis on the Trunk, Extremities and Face.

Trial Profile

An Open-Label Study of the Safety of A-101 Solution 40% in Subjects With Seborrheic Keratosis on the Trunk, Extremities and Face.

Completed
Phase of Trial: Phase III

Latest Information Update: 09 May 2017

At a glance

  • Drugs Hydrogen peroxide (Primary)
  • Indications Seborrhoeic keratosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Aclaris Therapeutics
  • Most Recent Events

    • 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 266887).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.
    • 01 Dec 2016 Status changed from active, no longer recruiting to completed.
    • 15 Nov 2016 Results published in an Aclaris Therapeutics Media Release
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