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A Long-term Safety and Efficacy Study of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea

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Trial Profile

A Long-term Safety and Efficacy Study of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 May 2018

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At a glance

  • Drugs Oxymetazoline (Primary)
  • Indications Erythema
  • Focus Adverse reactions
  • Acronyms REVEAL
  • Sponsors Allergan

    • Most Recent Events

    • 30 Jan 2018 Results published in the Journal of the American Academy of Dermatology
    • 23 May 2016 According to an Allergan media release, the NDA filing for oxymetazoline HCl cream 1.0% for the treatment of persistent facial erythema (redness) associated with rosacea in adults has been accepted by the US FDA for standard review. Allergan expects the Prescription Drug User Fee Act (PDUFA) date to be in the first half of 2017. The NDA submission was based on data collected from two phase 3 pivotal clinical trials of a 29-day treatment duration and a 1-year open label clinical trial.
    • 19 Nov 2015 Status changed from active, no longer recruiting to completed, as reported by ClinicalTrials.gov.
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