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An Open-Label Phase 4 Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris

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Trial Profile

An Open-Label Phase 4 Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 05 Mar 2020

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At a glance

  • Drugs Dapsone (Primary)
  • Indications Acne vulgaris
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Allergan
  • Most Recent Events

    • 10 Sep 2019 According to an Almirall media release, based on the data from thsi study, the FDA has approved Aczone 7.5% Gel , for the expanded indication to include patients aged 9-11 for the topical treatment of Acne vulgaris.
    • 11 Jun 2018 Status changed from recruiting to completed.
    • 11 Nov 2016 New trial record

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