Home / Drug News / Rhofade (oxymetazoline hydrochloride) FDA Approval

Rhofade (oxymetazoline hydrochloride) FDA Approval

Company: Allergan

Approval Status: Approved January 2017

Specific Treatments: facial erythema associated with rosacea

Therapeutic Areas


General Information

Rhofade (oxymetazoline hydrochloride) is an alpha1A adrenoceptor agonist. Oxymetazoline acts as a vasoconstrictor.

Rhofade is spccifically indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

Rhofade is supplied as a cream for topical administration. Apply a pea-sized amount of Rhofade cream, once daily in a thin layer to cover the entire face (forehead, nose, each cheek, and chin) avoiding the eyes and lips. Wash hands immediately after applying Rhofade cream.

Clinical Results

FDA Approval

The FDA approval of Rhofade was based on two identical, randomized, double-blind, vehicle-controlled, parallel-group clinical trials conducted in 885 subjects aged 18 years and older. Subjects applied either Rhofade or placebo once daily for 29 days. Disease severity was graded by the clinician using a 5-point clinician erythema assessment (CEA) scale and by the subject on a similar 5-point subject self-assessment (SSA) scale, on which subjects scored either “moderate” or “severe” on both scales. CEA and SSA were measured over a 12-hour period at equally-spaced timepoints (hours 3, 6, 9, and 12) postdose on Days 1, 15, and 29. The primary efficacy endpoint was defined as the proportion of subjects with at least a 2-grade reduction in erythema (improvement) from baseline (pre-dose on Day 1) on both the CEA and SSA measured at hours 3, 6, 9, and 12 on Day 29. In both pivotal trials, the primary efficacy endpoint was met. The proportion of patients achieving composite success were as follows: at hours 3, 6, 9 and 12 results in study 1 were Rhofade (N=222) 12%, 16%, 18%, 15% versus Placebo (N=218) 6%, 8%, 6%, 6% and in study 2 were Rhofade (N=224) 14%, 13%, 16% and 12% versus Placebo (N=221) 7%, 5%, 9% and 6%.

Side Effects

Adverse effects associated with the use of Rhofade may include, but are not limited to, the following:

  • application site dermatitis
  • worsening inflammatory lesions of rosacea
  • application site pruritis
  • application site erythema
  • application site pain

Mechanism of Action

Rhofade (oxymetazoline hydrochloride) is an alpha1A adrenoceptor agonist. Oxymetazoline acts as a vasoconstrictor.

Additional Information


About Dr. J. Kim

Dr Kim developed (and is continuing to develop) dermatology research news as we way from dermatologists to stay on top of the latest advances in the field of dermatology.

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