Topical Treatment Approved For Rosacea In Adults

01/19/2017

The FDA recently has approved the topical treatment, oxymetazoline hydrochloride (Rhofade, Allergan plc) cream, for patients with persistent facial erythema associated with rosacea in adults. Persistent facial redness is cited as the most common sign of rosacea, according to the National Rosacea Society.

Oxymetazoline hydrochloride’s approval was based on results from 2 identical, multicentered, randomized, double-blind, parallel-group, vehicle-controlled clinical trials that included 885 patients aged 18 or older with moderate or severe rosacea.

Results from the trials demonstrated that a once-daily application of oxymetazoline reduced persistent facial erythema associated with rosacea through 12 hours. The primary efficacy endpoint was at day 29 and was defined as the proportion of patients with at least a 2-grade reduction in erythema (improvement) from baseline (pre-dose on day 1) on both the clinician erythema assessment (CEA) and subject self-assessment (SSA) (composite success) measured at hours 3, 6, 9 and 12 versus vehicle. CEA and SSA also measured at Days 1 and 15 at hours 3, 6, 9, and 12.  The primary efficacy endpoint was met in both trials. Oxymetazoline hydrochloride will be available in May 2017.