Skin Inflammation Therapy Approved

The US Food and Drug Administration has approved Rhofade (Oxymetazoline hydrochloride) cream, 1%, for the topical treatment of persistent facial erythema associated with rosacea in adults.

Persistent facial redness is cited as the most common symptom of rosacea, which affects approximately 16 million Americans and may resemble a flushing sunburn that does not go away. The condition is most often triggered by sun exposure, stress, weather, food, exercise, or exposure to some products.
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The approval was based on the results of two clinical trials, both of which met primary efficacy endpoints. In the first study, the proportion of patients who received Rhofade (N = 222) achieving composite success at three, six, nine, and twelve hours were 12%, 16%, 18%, and 15%, respectively, compared with a vehicle-controlled group (n = 218) where rates were 6%, 8%, 6%, and 6%, respectively. In the second study (n = 224), rates for these same hour marks were 14%, 13%, 16%, and 12%, respectively, versus the vehicle group (n = 221), which had rates of 7%, 5%, 9%, and 6%, respectively.

From these results, investigators concluded that Rhofade was more effective than vehicle at reducing persistent facial erythema associated with rosacea in adults.

The most common adverse reactions for Rhofade were: application site dermatitis 2%, worsening inflammatory lesions of rosacea 1%, application site pruritus 1%, application site erythema 1%, and application site pain 1%.

"Historically, there haven't been many options available to help physicians address persistent facial erythema and often we ended up just helping our patients identify and manage triggers, which can lead to frustration for both the doctor and patient," said Robert Weiss, MD, clinical trial investigator and director of Maryland Laser, Skin & Vein Institute (Hunt Valley, MD). "With the approval of RHOFADE™, doctors will now be able to provide their patients with an effective once-daily treatment option to help manage this condition."—Sean McGuire

Reference

Once-Daily Treatment Reduces Persistent Facial Erythema (Redness) Associated With Rosacea Through 12 Hours(1) [press release]. Dublin, Ireland: Allergen press center; January 19, 2017. https://www.allergan.com/news/news/thomson-reuters/allergan-announces-fda-approval-of-rhofade-oxymet. Accessed January 19, 2017.