Allergan have listed their Phase 3 trials details for AGN-199201, their Oxymetazoline based treatment, called AGN-199201, for the persistent red face associated with rosacea.
Phase 3 trials like this one are interested in assessing the safety and efficacy of the active ingredient in a proposed treatment. Efficacy is proved by comparing the active treatment against the treatment’s vehicle carrier. Safety will be assessed by measuring adverse reactions by the investigators and participants.
Possible Competitor to Mirvaso
Allergan are keen to enter the market for treatments for the red face of rosacea, especially now that Mirvaso has been approved. Mirvaso is to date the only prescription product that has been approved by the FDA for a red face.
Allergan are surely watching the generally poor results being reported by users of Mirvaso and hoping for a better product.
What is Oxymetazoline?
Even though this trial doesn’t mention Oxymetazoline we know that that AGN-199201 is the code name for the oxymetazoline based product that Allergan purchased from Vicept Therapeutics.
Oxymetazoline is the active ingredient in decongestant products like Afrin, Sudafed OM and Vicks Sinex as well as in eye drops like Visine LR.
A well known side effect of Visine is rebound redness, where continued use leads to the redness that you were originally treating. Extended usage of Afrin can also lead to rebound nasal congestion.
Clinical Trial NCT02131636
This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.
Experimental: AGN-199201 AGN-199201 applied to the face once daily for 29 days.
Placebo Comparator: Vehicle Vehicle to AGN-199201 applied to the face once daily for 29 days.
Estimated Enrolment: 440
Study Start Date: June 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015