The official web site for Rhofade has gone live and now contains information that Allergan has not previously made public. Official web sites for prescription products normally contain statistics summarising clinical trial data, official dosage information, and other notes for doctors wanting to understand the cost and benefit of a new treatment.
For rosacea sufferers, a just-launched official web site is our first opportunity to see the official record of adverse reactions recorded in the clinical trials. This data as recorded in the Rhofade Prescribing Information will help answer the question – will Rhofade work for me?
Rhofade Adverse Reactions
Most common adverse reactions (incidence > 1%) are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema, and application site pain
The clinical trial participants who used Rhofade once daily for 1 year had the following adverse event frequency.
In the long-term (open-label) clinical trial, the rates of adverse reactions over a one-year treatment period were as follows:
- worsening inflammatory lesions of rosacea (3%),
- application site dermatitis (3%),
- application site pruritis (2%),
- application site pain (2%), and
- application site erythema (2%).
Subjects with persistent erythema along with inflammatory lesions were allowed to use additional therapy for the inflammatory lesions of rosacea
Rhofade – Rebound Redness?
Whilst not explicity designating any adverse events as rebound redness, one would expect any observed redness that was worse than the beginning of the trial would be covered under the event titled “application site erythema”. A small group of juse 2% – or around 5 people in 489 overall experienced redness as a result of using Rhofade. This result should encourage rosacea sufferers who were unable to use Mirvaso. It does have to be said, though, that in the real world Mirvaso seems to have had far more frequent adverse events compared to the clinical trials.
Rhofade is being promoted as ;
The first and only α 1A adrenoceptor agonist approved for persistent facial erythema associated with rosacea in adults.
doesn’t really roll of the tongue does it ?
Each gram of RHOFADE (oxymetazoline hydrochloride) cream contains 10 mg (1%) oxymetazoline hydrochloride, equivalent to 8.8 mg (0.88%) of oxymetazoline free base
sodium citrate dihydrate, citric acid anhydrous, disodium edetate dihydrate, butylated hydroxytoluene, anhydrous lanolin, medium chain triglycerides, diisopropyl adipate, oleyl alcohol, polyethylene glycol 300, PEG-6 stearate, glycol stearate, PEG-32 stearate, cetostearyl alcohol, ceteareth-6, stearyl alcohol, ceteareth-25, methylparaben, propylparaben, phenoxyethanol, and purified water
Tubes and Pumps
Rhofade will be available in 30gm and 60gm tubes and 30gm and 60gm pumps.