New Topical Cream Approved for Persistent Redness with Rosacea

Rhofade demonstrated greater efficacy vs. vehicle in a trial of 885 patients with moderate to severe rosacea
Rhofade demonstrated greater efficacy vs. vehicle in a trial of 885 patients with moderate to severe rosacea

Allergan announced that the Food and Drug Adminisration (FDA) has approved Rhofade (oxymetazoline HCl) cream for the topical treatment of persistent facial erythema associated with rosacea in adults.

Rhofade, the first alpha 1A adrenoceptor agonist approved for this indication, was evaluated in two identical, multicentered, randomized, double-blind, parallel-group, and vehicle-controlled trials in moderate or severe patients (n=885). Once-daily Rhofade demonstrated a reduction in persistent facial erythema associated with rosacea through 12 hours in two clinical trials. The primary efficacy endpoint at Day 29 was defined as the proportion of patients with at least a 2-grade reduction in erythema 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 vs. vehicle. The CEA and SSA were also measured at Days 1 and 15 at Hours 3, 6, 9, and 12.  

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Rhofade demonstrated greater efficacy vs. vehicle in reducing persistent facial erythema associated with rosacea in adults. In both trials, the proportion of patients achieving composite success were as follows at Hours 3, 6, 9, and 12:

  • Study 1: Rhofade 12%, 16%, 18%, 15% vs. Vehicle  6%, 8%, 6%, 6% 
  • Study 2: Rhofade 14%, 13%, 16% and 12% vs. Vehicle 7%, 5%, 9% and 6%

Rhofade will be available as a 1% strength topical cream in May 2017.

For more information call (800) 433-8871 or visit Rhofade.com.