A Long-term Safety and Efficacy Study of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea
Phase of Trial: Phase III
Latest Information Update: 28 Sep 2016
At a glance
- Drugs Oxymetazoline (Primary)
- Indications Erythema
- Focus Adverse reactions
- Sponsors Allergan
- 07 Jun 2017 Biomarkers information updated
- 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.