First Topical Agent for Facial Erythema of Rosacea Approved

Brimonidine topical gel 0.33% (Mirvaso, Galderma Laboratories) has been approved by the FDA for facial redness resulting from rosacea in adults aged 18 years or older

In clinical testing, the alpha 2 adrenergic agonist brimonidine topical gel yielded significantly greater improvement in the facial redness of rosacea than vehicle gel, according to the company sponsor of the clinical trial. Testing included 2 phase 3 clinical trials involving more than 550 patients, each lasting 1 month, and a long-term trial with 276 patients lasting up to 12 months.

Brimonidine topical gel is thought to work by constricting dilated facial blood vessels to reduce the redness of rosacea. It is intended to be applied in a pea-sized amount once daily to the forehead, chin, nose, and each cheek.

The most common adverse reactions (incidence ≥ 1%) seen in the short-term trials were erythema, flushing, skin burning sensation, and contact dermatitis.

In the long-term study, the most common adverse events (≥4% of subjects) included flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%).

Galderma expects Mirvaso to be available in pharmacies in September 2013.

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About Rosacea (Acne Rosacea)

Rosacea (Acne Rosacea) is an inflammatory skin disorder that affects the blood vessels and pilosebaceous units of the face, specifically the central areas; the lateral aspects of the cheeks and forehead are typically spared. Rosacea appears as a background of erythema and telangiectasias (fine blood vessels), usually with superimposed papules and pustules developing gradually over time. Flushing usually precedes permanent erythema. Comedones are not found, distinguishing it from acne vulgaris. Onset is in middle-age, also distinguishing this condition from acne vulgaris.

What else can look like rosacea?

The primary differential diagnosis for acne rosacea is acne vulgaris.  Acne rosacea begins in middle age, lacks comedones, has background erythema and telangiectasias, and a characteristic central facial distribution.  Seborrheic dermatitis, systemic lupus erythematosus, or a photodermatoses can resemble rosacea if pustules are lacking. The flushing sometimes seen in early acne rosacea can be confused with carcinoid syndrome.

Acne rosacea is usually diagnosed clinically based on history and a typical appearance.

What are the treatments for acne rosacea

Low dose systemic antibiotics, such as tetracycline or erythromycin, are usually used for papules and pustules. Topical metronidazole (e.g. MetroGel) is commonly used, as is topical azelaic acid (e.g. Finacea) and sometimes permethrin. Systemic isotretinoin has been used for resistant disease. Topical steroids should be avoided as the are known to aggravate rosacea. Sun screen should be worn regularly as sunlight is one of many aggravating factors. Telangiectasias and erythema may be responsive to laser treatments or IPL.  Triggers of flushing should be avoided.Ocular complications should be referred to an ophthalmologist.  Rhinophyma can be treated with electrosection of the hypertrophic tissue, or other ablative technique.

What is the prognosis for acne rosacea?

Acne rosacea, although a chronic disease, can usually be controlled with treatment. Papules, pustules, and sometimes erythema may resolve with antibiotics, but telangiectasias persist unless ablated with a vascular laser or IPL device. Rhinophyma, which is hyperplasia of the sebaceous glands of the nose, develops in some cases. This condition can also affect the chin.  Eye complications, ranging from blepharitis to keratitis, are not uncommon in rosacea patients.

Other Resources – Acne RosaceaNational Rosacea Society | International Rosacea Foundation | Acne Rosacea from Dermatology On-Line Journal

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