Skin Associates Instrumental in New Rosacea Cream Approval

rosaceaFor over a decade, Skin Associates of South Florida has been the site of numerous clinical trials in the research and testing of newest breakthroughs in dermatological skincare advances.

Our state-of-the-art Skin Research Institute facility, located at our dermatology office in Coral Gables, performs dozens of U.S. Food and Drug Administration (FDA)-approved clinical research protocols each year for national pharmaceutical biotechnology and medical device companies.

Thus we are proud to announce our participation in the approval of a new topical treatment for rosacea, oxymetazoline hydrochloride 1% cream (Rhofade) made by Allergan. Oxymetazoline is the active ingredient in decongestant products like Afrin, Sudafed OM and Vicks Sinex, as well as in eye drops like Visine LR. Both Visine, used for redness in the eyes, and Afrin, used to treat nasal congestion, have well-known rebound effects, in which the treatment can cause a worsening of the condition being treated. Rhofade is significant in that there appears to be no rebound effect from use of the drug.

Rosacea, or persistent facial erythema, is the chronic inflammation of the skin characterized by facial redness or flushing. It is typically triggered by sun exposure, exercise, heat, emotional upset, some foods (including alcohol), and various topical products. The National Rosacea Society (NRS) estimates that as many as 16 million Americans are affected by rosacea, and until now physicians have had few options with which to treat it.

The persistent facial erythema associated with rosacea is “a challenge for patients and physicians, and having options can help in treating the disease,” David Nicholson, Allergan’s head of research and development, said in a news release announcing approval of the drug.

The FDA approval was based on two studies involving 885 adults aged 18 years and older, who complained of moderate-to-severe rosacea. In both trials, Rhofade applied once daily reduced persistent facial erythema associated with rosacea through 12 hours, the company said.

“Rhofade is the first and only alpha1A adrenoceptor agonist approved for persistent facial erythema associated with rosacea in adults. The approval of Rhofade represents a new prescription treatment that can effectively help physicians and their patients manage this condition,” Nicholson said.

The most common adverse reactions with Rhofade were application-site dermatitis, seen in 2% of participants, and worsening inflammatory lesions of rosacea, application site pruritus, application site erythema, and application site pain (1% each).

Allergan expects Rhofade to be available in May 2017.

Skin Associates of South Florida is so proud to have been a part of the studies that led to this new rosacea cream being approved. Congratulations, Allergan!