Rhofade website and prescribing information is live

rhofade-tube

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.

Marketing Mouthful

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 ?

Rhofade Ingredients

Active Ingredients

Each gram of RHOFADE (oxymetazoline hydrochloride) cream contains 10 mg (1%) oxymetazoline hydrochloride, equivalent to 8.8 mg (0.88%) of oxymetazoline free base

Inactive Ingredients

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.

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About the Author

About the Author:

David Pascoe started the Rosacea Support Group in October 1998.

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7 Reader Comments

  1. Kevin says:

    My dermatologist has samples available now (I presume this will be the same over the US), I will be getting some next week and report on what happens after a few days of use.

  2. David Pascoe says:

    Question via email.

    “I have been using Mirvaso for a year now and found it helpful for the redness would rhofade take its place? how could I obtain another cost reduction card for Mirvaso?
    Thank you ,
    H. R.”

  3. samoht says:

    i would love to get some samples here in switzerland.

  4. Sean says:

    Used Mirvaso previously and due to the rebound it made my skin worse and had to stop.

    Anyone know if Rhofade is any different?

  5. Brenda says:

    Is it covered by insurance?

  6. Charles Penix says:

    Should moisturizer be applied before or after Rhofade. How many ch time between applications?

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