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Oxymetazoline Hydrochloride 1% Cream (Rhofade) for Persistent Facial Erythema Associated with Rosacea

 

Am Fam Physician. 2018 Jun 15;97(12):808-810.

Oxymetazoline hydrochloride 1% cream (Rhofade) is an alpha1A adrenoceptor agonist labeled for the topical treatment of persistent facial erythema associated with rosacea in adults. It is thought to work through topical vasoconstriction.1

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DrugDosageDose formCost*

Oxymetazoline hydrochloride 1% cream (Rhofade)

Apply a thin layer to the entire face once daily

30-g tube

$540


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed April 25, 2018).

DrugDosageDose formCost*

Oxymetazoline hydrochloride 1% cream (Rhofade)

Apply a thin layer to the entire face once daily

30-g tube

$540


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed April 25, 2018).

Safety

Studies have shown oxymetazoline cream to be safe with few adverse effects. Basal cell carcinoma is the most serious adverse effect reported at a rate of 1.3%, although this rate does not appear to be higher than at baseline.2,3 Systemic alpha-adrenergic effects are possible, but they have not been reported in clinical studies. Oxymetazoline cream has not been evaluated in patients with vascular insufficiency, orthostatic hypotension, cardiovascular disease, or narrow-angle glaucoma. It has not been evaluated in pregnant or breastfeeding women, but risk of fetal or infant harm is not expected because of minimal systemic absorption.

Tolerability

Oxymetazoline cream is generally well tolerated. Application site dermatitis, pruritus, worsening erythema, and pain will occur in 1% to 3% of users. In two studies, 2.6% of patients discontinued treatment compared with 0.5% of patients using placebo cream.1

Effectiveness

Oxymetazoline cream will improve redness scores by at least two points on a five-point scale by clinical assessment in 12% to 18% of patients with moderate to severe rosacea (number needed to treat [NNT] = 17) after

Address correspondence to Christina Garcia, DO, MPH, at Christina.garcia@carolinashealthcare.org. Reprints are not available from the authors.

References

show all references

1. DailyMed. Drug label information. Rhofade—oxymetazoline hydrochloride cream. Updated January 18, 2017. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ba1cc5b-4f7f-491b-a5af-a6a14fb5affd. Accessed September 28, 2017....

2. Allergan [sponsor]. A long-term safety and efficacy study AGN-19920 in patients with persistent erythema associated with rosacea. Updated September 21, 2016. https://clinicaltrials.gov/ct2/show/NCT02095158. Accessed November 5, 2017.

3. Baumann L, Goldberg DJ, Stein Gold L, et al. Pivotal trial of the efficacy and safety of oxymetazoline cream 1.0% for the treatment of persistent facial erythema associated with rosacea: findings from the second REVEAL trial. J Drugs Dermatol. 2018;17(3):290–298.

4. Kircik LH, DuBois J, Draelos ZD, et al. Pivotal trial of the efficacy and safety of oxymetazoline cream 1.0% for the treatment of persistent facial erythema associated with rosacea: findings from the first REVEAL trial. J Drugs Dermatol. 2018;17(1):97–105.

5. Allergan [sponsor]. Safety and efficacy of oxymetazoline HCl cream 1.0% in patients with persistent erythema associated with rosacea. Updated August 2, 2016. https://clinicaltrials.gov/ct2/show/NCT02132117?cond=oxymetazoline+cream&rank=1. Accessed November 5, 2017.

6. Shanler SD, Ondo AL. Successful treatment of the erythema and flushing of rosacea using a topically applied selective α1-adrenergic receptor agonist, oxymetazoline. Arch Dermatol. 2007;143(11):1369–1371.

7. Wilkin J, Dahl M, Detmer M, et al. Standard classification of rosacea: report of the National Rosacea Society expert committee on the classification and staging of rosacea. J Am Acad Dermatol. 2002;46(4):584–587.

 

 

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