Updated July 21, 2014.
Written or reviewed by a board-certified physician. See About.com's Medical Review Board.
Rosacea and facial redness
Rosacea is a skin condition that affects 16 million Americans. It is seen most commonly in Caucasian women, but can affect all races and both genders. Rosacea usually begins between 20 to 50 years of age and generally continues throughout life.
Symptoms of rosacea include small visible blood vessels (called telangiectasias) and small acne-like bumps over the cheeks, nose and forehead.
Some individuals may additionally experience thickening of areas of the skin such as over the nose (rhinophyma), or burning in their eyes (ocular rosacea). The most commonly reported symptom, however, is facial redness.
The facial redness of rosacea is caused by a combination of two factors:
Topical and oral medications to treat the acne-like bumps of rosacea have been available for years but only help with the redness surrounding the bumps.
Mirvaso® was approved by the Food and Drug Administration in 2013. It is the first topical medication that specifically treats the widespread, background redness of rosacea.
How does Mirvaso® work?
The active ingredient in Mirvaso® is brimonidine. The widespread, background redness of rosacea is caused by increased blood flow through abnormally enlarged blood vessels located just under the skin.
Brimonidine decreases facial redness by causing these blood vessels to become narrower and consequently decreasing the amount of blood flow through them.
Mirvaso® is currently FDA-approved for use in individuals over the age of 18 with chronic facial redness (not for “flushing,” or temporary facial redness). It comes as a topical gel in a single strength of 0.33%.
How well does Mirvaso® work?
So far, there have been three pharmaceutical-sponsored studies examining the efficacy of Mirvaso®.
Two studies were short-term, randomized controlled studies in which subjects received 4-weeks of either Mirvaso® or placebo, followed by 4-weeks of no treatment. In the third study, all subjects received 1-year of daily Mirvaso treatment. The success of the drug was measured in each study based on visual improvement as judged by the patient and as judged by their doctor.
In all three studies, an improvement in facial redness was noted on the first day of use. Patients did not build a tolerance to the medication with daily use. No change in the effectiveness or safety of Mirvaso® was noted when it was used in combination with other rosacea treatments typically prescribed for the acne-like bumps.
What are the most common side effects?
In the one-year study, the most commonly observed related side effects (seen in =2% of subjects) were:
In the short-term studies, a small number of subjects reported worsening of facial redness after stopping topical treatment, but the number of subjects reporting this side effect were similar between the treatment and placebo groups.
A recent case series suggests that some individuals develop rebound worsening of the redness and burning that limits its use. These individuals often discontinue usage or save use for special events.
Is Mirvaso® safe for everyone?
Since the active ingredient in Mirvaso® acts on blood vessels, your doctor may need to take some additional precautions if you have other medical conditions or take other medications that also involve or act on blood vessels. Therefore, let your doctor knowif you have heart, circulation, or blood pressure problems. Additionally inform your doctor if you have dizziness or a drop in blood pressure upon standing, depression, Sjogren’s syndrome, scleroderma, Raynaud’s phenomenon, or have had a stroke.
What if I am pregnant? The risks of Mirvaso® during pregnancy are not known. You and your doctor should discuss the potential risks and benefits.
What if I am breastfeeding? You should discuss with your doctor and choose either breastfeeding or Mirvaso® treatment.
What if I am over the age of 65? While differences in medication response have not specifically been studied between this age group and younger subjects, initial studies do not appear to show any difference in safety or effectiveness.
References:
National Rosacea Society. Information for patients. [Accessed Feb 21, 2014].http://www.rosacea.org/patients/index.php.
Del Rosso JQ. Management of facial erythema of rosacea: What is the role of topical a- adrenergic agonist therapy? J Am Acad Dermatol. 2013;69:S44-56.
Fowler J, Jarrat M, Moore A, et al. Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized, and vehicle-controlled studies. Br J Dermatol. 2012;166(3):633-641.
Mirvaso®[package insert]. Fort Worth, TX: Galderma Laboratories: 2013.
Moore A, Kempers S, Murakawa G, et al. Long-term safety and efficacy of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: Results of a 1-year open-label study. J Drugs Dermatol. 2014;13(1);56-61.
Powell FC. Clinical Practice. Rosacea. N Engl J Med. 2005;352(8):793-803.
Routt ET, Levitt JO. Rebound erythema and burning sensation from a new topical brimonidine tartrate gel 0.33%. J Am Acad Dermatol. 2014;70(2): e37-e38.
Written or reviewed by a board-certified physician. See About.com's Medical Review Board.
Rosacea and facial redness
Rosacea is a skin condition that affects 16 million Americans. It is seen most commonly in Caucasian women, but can affect all races and both genders. Rosacea usually begins between 20 to 50 years of age and generally continues throughout life.
Symptoms of rosacea include small visible blood vessels (called telangiectasias) and small acne-like bumps over the cheeks, nose and forehead.
Some individuals may additionally experience thickening of areas of the skin such as over the nose (rhinophyma), or burning in their eyes (ocular rosacea). The most commonly reported symptom, however, is facial redness.
The facial redness of rosacea is caused by a combination of two factors:
- Redness around the individual acne-like bumps
- Widespread, background redness across the nose, cheeks, and forehead that may occasionally worsen but is present at all times.
Topical and oral medications to treat the acne-like bumps of rosacea have been available for years but only help with the redness surrounding the bumps.
Mirvaso® was approved by the Food and Drug Administration in 2013. It is the first topical medication that specifically treats the widespread, background redness of rosacea.
How does Mirvaso® work?
The active ingredient in Mirvaso® is brimonidine. The widespread, background redness of rosacea is caused by increased blood flow through abnormally enlarged blood vessels located just under the skin.
Brimonidine decreases facial redness by causing these blood vessels to become narrower and consequently decreasing the amount of blood flow through them.
Mirvaso® is currently FDA-approved for use in individuals over the age of 18 with chronic facial redness (not for “flushing,” or temporary facial redness). It comes as a topical gel in a single strength of 0.33%.
- To use: Once a day, take a pea-sized amount of the gel and dot it across your forehead, cheeks, and chin. Spread and blend to create a thin, even film across your entire face. Avoid your lips, eyes, and any open cuts or sores.
- Make sure you wash your hands immediately after you apply the gel. Mirvaso® is to be used only on the skin. You do not want to accidentally spread it elsewhere.
- Keep Mirvaso® away from children. Children can experience serious, life-threatening problems if they accidentally eat even a small amount of Mirvaso®.
How well does Mirvaso® work?
So far, there have been three pharmaceutical-sponsored studies examining the efficacy of Mirvaso®.
Two studies were short-term, randomized controlled studies in which subjects received 4-weeks of either Mirvaso® or placebo, followed by 4-weeks of no treatment. In the third study, all subjects received 1-year of daily Mirvaso treatment. The success of the drug was measured in each study based on visual improvement as judged by the patient and as judged by their doctor.
In all three studies, an improvement in facial redness was noted on the first day of use. Patients did not build a tolerance to the medication with daily use. No change in the effectiveness or safety of Mirvaso® was noted when it was used in combination with other rosacea treatments typically prescribed for the acne-like bumps.
What are the most common side effects?
In the one-year study, the most commonly observed related side effects (seen in =2% of subjects) were:
- Flushing
- Worsening of facial redness
- Worsening of rosacea
- Burning feeling on the skin
- Skin irritation
- Skin allergy
- Itch
In the short-term studies, a small number of subjects reported worsening of facial redness after stopping topical treatment, but the number of subjects reporting this side effect were similar between the treatment and placebo groups.
A recent case series suggests that some individuals develop rebound worsening of the redness and burning that limits its use. These individuals often discontinue usage or save use for special events.
Is Mirvaso® safe for everyone?
Since the active ingredient in Mirvaso® acts on blood vessels, your doctor may need to take some additional precautions if you have other medical conditions or take other medications that also involve or act on blood vessels. Therefore, let your doctor knowif you have heart, circulation, or blood pressure problems. Additionally inform your doctor if you have dizziness or a drop in blood pressure upon standing, depression, Sjogren’s syndrome, scleroderma, Raynaud’s phenomenon, or have had a stroke.
What if I am pregnant? The risks of Mirvaso® during pregnancy are not known. You and your doctor should discuss the potential risks and benefits.
What if I am breastfeeding? You should discuss with your doctor and choose either breastfeeding or Mirvaso® treatment.
What if I am over the age of 65? While differences in medication response have not specifically been studied between this age group and younger subjects, initial studies do not appear to show any difference in safety or effectiveness.
References:
National Rosacea Society. Information for patients. [Accessed Feb 21, 2014].http://www.rosacea.org/patients/index.php.
Del Rosso JQ. Management of facial erythema of rosacea: What is the role of topical a- adrenergic agonist therapy? J Am Acad Dermatol. 2013;69:S44-56.
Fowler J, Jarrat M, Moore A, et al. Once-daily topical brimonidine tartrate gel 0.5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized, and vehicle-controlled studies. Br J Dermatol. 2012;166(3):633-641.
Mirvaso®[package insert]. Fort Worth, TX: Galderma Laboratories: 2013.
Moore A, Kempers S, Murakawa G, et al. Long-term safety and efficacy of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: Results of a 1-year open-label study. J Drugs Dermatol. 2014;13(1);56-61.
Powell FC. Clinical Practice. Rosacea. N Engl J Med. 2005;352(8):793-803.
Routt ET, Levitt JO. Rebound erythema and burning sensation from a new topical brimonidine tartrate gel 0.33%. J Am Acad Dermatol. 2014;70(2): e37-e38.
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