Rhofade good for at least a year and gentler than Mirvaso

16DERM030_Figure 1_v03 - JD

If you decide to try Allergan’s topical for redness – Rhofade, is it likely to work for you, and how long should you expect it to continue to work for you?

Well, a year long study of users of Rhofade has found that the vast majority continued to enjoy ongoing significant relief from their facial redness for at least a year.

Here is everything you need to know about using Rhofade long term.

The big picture result

Success in this trial was determined both by the clinicians and the study participants, as a 2 grade or better improvement in facial redness at weeks 4, 26 and 52. As the trial progressed, more and more of the participants reported success.

By the time the trial finished, after 52 weeks, 43.4% of the participants still in the trial had a 2 grade or better improvement in their facial redness, 6 hours after application.

Will Rhofade work for me?

Based on the outcomes of this large scale study, you can expect to have an almost 50/50 chance in achieving significant relief from your facial redness using Rhofade.

Rebound Redness – will I get it?

One legitimate concern for rosacea sufferers using a topical for redness is whether they will experience worsening of their redness either during the treatment, or when they cease using the topical.

Only 0.7% of the 440 participants reported rebound redness at week 54, 2 weeks after the completion of the study. This amounts to just 3 people in the trial. When this few participants suffer from a rebound redness event it is classified as `not clinically. relevant’.

So it is quite unlikely that you will experience rebound redness from Rhofade.

What is a 2 grade improvement in redness?

In order to have a basis to measure any worsening or improvement in facial redness, a scale is needed.

GradeCEA scale descriptionSSA scale description
0Clear skin with no signs of erythemaNo signs of unwanted redness
1Almost clear, slight rednessAlmost clear of unwanted redness
2Mild erythema, definite rednessMild redness
3Moderate erythema, marked rednessModerate redness
4Severe erythema, fiery redness Severe redness
Clinician Erythema Assessment and Subject Self-Assessment for rosacea facial redness scale descriptions

Successful treatment with Rhofade was based on observing an improvement of 2 grades for eg. you were able to move from moderate to almost clear redness.

What is the Clinician Erythema Assessment?

Ranging from 0 meaning no sign of redness, to 4 which is the most severe `firey’ redness, the clinician erythema assessment is decided by your doctor who makes their judgement by examining you in their clinic.

What is the Subject Self-Assessment?

Similar to the clinician scale, the patient scale goes from 0 to 4, but with a simpler description for each severity of redness.

What adverse reactions are there after a year?

One of the good things about such a long-term and comprehensive trial is that you can get a reliable indication of the sorts of unintended effects and how often they occur. This will allow all rosacea sufferers to gain an insight into what sort of reaction they should, on average, expect for themselves.

We already know that there is a list of people who should NOT use Rhofade, and now the statistics of this study show that the following adverse reactions were observed. Only 3.2% of participants experienced a reaction that caused them to cease treatment.

Rhofade Adverse Events

Adverse EventOccurence
Upper respiratory tract infection3.6%
Worsening inflammatory lesions of rosacea3.2%
Application-site dermatitis3.0%
Nasopharyngitis (common cold)3.0%
Hypertension (high blood pressure2.5%
Headache2.3%
Sinusitis2.3%
Application-site pain2.0%
Application-site pruritus (itching 2.0%
Occurrence of adverse events reported during the entire study period.

Note that there is no mention of any adverse events related to valvulopathy as hinted from a recent theoretical paper discussing a potential risk relating to the 5-HT2B receptor and oxymetazoline.

See the full article for a more detailed listing of all adverse events.

Rhofade is gentler than Mirvaso

As noted in the study, the long term efficacy and tolerability of Rhofade and Mirvaso differ;

Differences in mechanism of action between oxymetazoline, an a1A-adrenoceptor
agonist, and brimonidine, a selective a2-adrenoceptor agonist, may contribute to differences in their safety profiles observed in the respective long-term safety studies.

Indeed some recent laboratory research has further highlighted the different chemistry involved in how oxymetazoline and brimonidine affect skin.

In a similar 1 year trial of Mirvaso, 17% of participants discontinued the trial early because of adverse effects, compared to just 3% for Rhofade. So it seems that the clinical trial data is matching what we are observing in online reports as well – Rhofade is in general, better tolerated than Mirvaso.

Goods new for Rhofade users

So this paper is confirmation for rosacea sufferers that Rhofade can be relied on to give good relief to a decent proportion of facial redness sufferers with only a small proportion of users expected to experience significantly negative effects.

Article Abstract

Efficacy and safety of oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: Findings from the 52-week open label REVEAL trial

J Am Acad Dermatol. 2018 Jun;78(6):1156-1163.

Draelos ZD, Gold MH, Weiss RA, Baumann L, Grekin SK, Robinson DM, Kempers SE, Alvandi N, Weng E, Berk DR, Ahluwalia G.

Objective: To examine the long-term safety and efficacy of oxymetazoline cream 1.0% in patients with rosacea with moderate-to-severe persistent erythema.

Methods: Patients applied oxymetazoline once daily for 52 weeks. Safety assessments included treatmentemergent adverse events (TEAEs), skin blanching, inflammatory lesion counts, telangiectasia, disease severity, and rebound effect. Efficacy was assessed by the Clinician Erythema Assessment and Subject Self-Assessment composite score at 3 and 6 hours after the dose on day 1 and at weeks 4, 26, and 52.

Results: Among 440 patients, 8.2% reported treatment-related TEAEs; the most common were application site dermatitis, paresthesia, pain, and pruritus. The rate of discontinuation due to adverse events (mostly application-site TEAEs) was 3.2%.

No clinically meaningful changes were observed in skin blanching, inflammatory lesions, or telangiectasia.

At week 52, 36.7%, and 43.4% of patients achieved a 2-grade or greater composite improvement from baseline in both Clinician Erythema Assessment and Subject Self-Assessment 3 and 6 hours after a dose, respectively.

Less than 1% of patients experienced a rebound effect following treatment cessation.

Limitations: A vehicle-control group was not included.

Conclusion: This long-term study demonstrated sustained safety, tolerability, and efficacy of oxymetazoline for moderate-to-severe persistent erythema of rosacea.

Key words: a-adrenergic receptors; b-adrenergic receptors; facial dermatoses; skin abnormalities; vascular skin diseases; vasoconstrictor agents.

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About the Author

About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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2 Reader Comments

  1. David Pascoe says:

    Comment from laser_cat at the Rosacea Forum

    “Just pulling this quote out for others; a clear explanation on the differences between rhofade / mirvaso in terms of mechanism of action


    “Persistent facial erythema involves a complex pathophysiology of neurovascular dysregulation, enhanced immune response, and alteration of the cutaneous vasculature.15 Modifications in the superficial cutaneous vasculature are regulated primarily by the sympathetic nervous system.15, 16, 17 Oxymetazoline causes vasoconstriction primarily by activating α1A-adrenoceptors; conversely, brimonidine (Mirvaso, Galderma Laboratories, Fort Worth, TX), which is another treatment for persistent erythema of rosacea, causes vasoconstriction through α2-adrenoceptors.11, 12, 15, 18 Vascular smooth muscle cells express α1-adrenoceptors postsynaptically; thus, activation by an α-adrenoceptor agonist results in vasoconstriction.16 In contrast, α2-adrenoceptors may be expressed presynaptically and/or postsynaptically, depending on vessel type.16, 17 Activation of postsynaptic α2-adrenoceptors in the vascular smooth muscle causes vasoconstriction, but activation of presynaptic α2-adrenoceptors or α2-adrenoceptors in the vascular endothelium results in vasodilation, which may counteract the vasoconstrictor effect. Differences in mechanism of action between oxymetazoline, an α1A-adrenoceptor agonist,11, 12 and brimonidine, a selective α2-adrenoceptor agonist,18 may contribute to differences in their safety profiles observed in the respective long-term safety studies.19”

    (perhaps a helpful visual for this – https://www.cvpharmacology.com/vasoconstrictor/alpha-agonist )

    I’m personally surprised of the low rate of rebound. I would think rhofade would be similar to sudafed (which also acts on the alpha adrenergic receptors causing vasoconstriction) and afrin (same active ingredient as rhofade), in that repeated use causes rebound congestion/swelling/vasodilation. Maybe the lining of the nasal passages is just a different can of worms than the facial skin.

    It would be interesting to see a similar year-long study on how rhofade gets along with “flushers” (as opposed to persistent redness). As well as topical timolol / beta blockers!

    PS Really find your rosacea site very informative David, thanks “

  2. Patryk says:

    Why is so much expensive?

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