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Rhofade Approved by FDA

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Rhofade Approved by FDA • Rhofade Official Web Site

"Topical oxymetazoline applied to the face once daily for 29 days was effective, safe, and well tolerated in the treatment of moderate to severe persistent facial erythema of rosacea." [1]

"Expert commentary: While assessment of available clinical trial data indicates that the medication is as effective as other available treatment for controlling rosacea-associated erythema with minimal risk of adverse effects, studies of long-term duration and direct comparison will be necessary to establish its place in treatment guidelines and clinical practice. As further evidence becomes available, the real-world clinical potential of topical oxymetazoline cream will become clearer." [2]

"For both QD and BID dosing, the efficacy of oxymetazoline 1.0% was greater than the 0.5% dose and comparable to the 1.5% dose. Safety and application-site tolerability were similar across groups." [3]

Rhofade, also known as oxymetazoline hydrochloride cream (1 percent strength), is a topical cream made to treat persistent facial erythema (redness). Ask your dermatologist for a sample. 

The odds in the clinical trials of potential side effects using Rhofade for four weeks are 1% and go up to 3% using Rhofade for one year. 

There is a non prescription oxymetazoline ( 0.075%) topical cream available by a compounding pharmacy in Australia

Please post your experience using Rhofade in this thread. 

rhofade.png

End Notes

[1] J Drugs Dermatol. 2018 Mar 01;17(3):290-298
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.
Baumann L, Goldberg DJ, Stein Gold L, Tanghetti EA, Lain E, Kaufman J, Weng E, Berk DR, Ahluwalia G

[2] Expert Rev Clin Pharmacol. 2017 Oct;10(10):1049-1054. doi: 10.1080/17512433.2017.1370370. Epub 2017 Aug 24.
Oxymetazoline hydrochloride cream for facial erythema associated with rosacea.
Patel NU1, Shukla S1, Zaki J1, Feldman SR1,2,3.

[3] J Drugs Dermatol. 2018 Mar 1;17(3):308-316.
Phase 2 Randomized, Dose-Ranging Study of Oxymetazoline Cream for Treatment of Persistent Facial Erythema Associated With Rosacea.
DuBois J, Dover JS, Jones TM, Weiss RA, Berk DR, Ahluwalia G.

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"Topical oxymetazoline applied to the face once daily for 29 days was effective, safe, and well tolerated in the treatment of moderate to severe persistent facial erythema of rosacea."

J Drugs Dermatol. 2018 Mar 1;17(3):290-298.
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.
Baumann L, Goldberg DJ, Stein Gold L, Tanghetti EA, Lain E, Kaufman J, Weng E, Berk DR, Ahluwalia G.

"Oxymetazoline applied to the face once daily for 29 days was effective, safe, and well tolerated in patients with moderate to severe persistent facial erythema of rosacea."

J Drugs Dermatol. 2018 Jan 1;17(1):97-105.
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.
Kircik LH, DuBois J, Draelos ZD, Werschler P, Grande K, Cook-Bolden FE, Weng E, Berk DR, Ahluwalia G.

"The topical use of oxymetazoline 0.05% solution in the management of rosacea has been primarily limited to data from case series involving fewer than 10 patients and demonstrating sustained improvements in both erythema and flushing. Alhough oxymetazoline is not recognized in national guidelines, an international consensus statement recognizes the possible therapeutic role of oxymetazoline in the management of rosacea, despite the limited evidence."

Hosp Pharm. 2013 Jul-Aug; 48(7): 558–559.
Published online 2013 Jul 9. doi:  10.1310/hpj4807-558
PMCID: PMC3839519
Oxymetazoline (Topical): Rosacea
Joyce A. Generali, RPh, MS, FASHP, (Editor) and Dennis J. Cada, PharmD, FASHP, FASCP

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