First new treatment for rosacea in a decade to debut

February 17, 2003

The FDA recently approved azelaic acid (Finacea, Berlex Laboratories) 15.0% gel for the topical treatment of the inflammatory papules and pustules characteristic of mild-to-moderate rosacea. Finacea should be available in pharmacies during the first quarter of 2003.

 

Rx CARE

First new treatment for rosacea in a decade to debut

Clinicians and their patients will soon have available to them the first new treatment for rosacea to be approved in more than 10 years. The Food & Drug Administration recently approved azelaic acid (Finacea, Berlex Laboratories) 15.0% gel for the topical treatment of the inflammatory papules and pustules that are characteristic of mild-to-moderate rosacea. Finacea should be available in pharmacies during the first quarter of 2003 in time for March, designated National Rosacea Awareness Month by the National Rosacea Society.

According to James Del Rosso, D.O., clinical assistant professor, department of dermatology, University of Nevada School of Medicine, Las Vegas, azelaic acid is a naturally occurring, saturated dicarboxylic acid. The aqueous gel formulation of Finacea allows for increased solubility of the microparticles of azelaic acid over the cream formulation and better delivery of the active medication into the skin, he said. Clinical trials found no increase in the urinary concentration of azelaic acid, despite the improved penetration of the drug, said Del Rosso. He pointed out that systemic toxicity is not a concern with Finacea.

The drug was well tolerated in clinical trials, Del Rosso noted. The most common adverse event associated with Finacea use was a transient stinging, burning, or tingling sensation. Finacea should be applied gently to the affected areas twice daily, in the morning and in the evening. As stated in the package insert, the mechanisms by which Finacea interferes with the pathogenic events of rosacea are unknown.

Del Rosso feels the real value of Finacea is that it will provide clinicians and patients with an additional therapeutic option. No one medication is effective for every patient, he explained. A trial of two to three months is considered adequate to assess the efficacy of a particular medication in a particular patient.

Once patients find a therapeutic regimen that works for them, they must adhere to it on a long-term basis. They cannot stop using their medication once their condition improves, he cautioned, because the rosacea can return. In addition, patients still may experience flare-ups of their rosacea, even if they use their medication diligently. The good news is that the flare-ups are less frequent and less severe.

To treat the more severe cases of rosacea, patients may be given an oral antibiotic in addition to a topical agent. The goal of therapy, Del Rosso explained, is to get the patient to taper off the oral antibiotic and continue with just the topical therapy.

Patients should be instructed to use gentle skin cleansers, such as Cetaphil, advised Del Rosso. They should also be told to avoid sun exposure and use a moisturizer with sunscreen, such as Cetaphil Cream with SPF 15. Patients should understand, Del Rosso said, that they must apply their topical medication before their moisturizer, to allow the medication to be absorbed into the skin.

Shortly after the approval of Finacea, Doak Dermatologics announced that its Rosula Lotion (sodium sulfacetamide 10% and sulfur 5% in a 10% urea vehicle) has received clearance for the treatment of rosacea and acne. According to Todd Miller, senior product manager at Doak, what's different about this product is that it contains 10% urea, which alleviates dryness from skin treatments and prevents irritation. He added that the other ingredients—sodium sulfa-cetamide and sulfur—have been around on a long-standing basis.

As part of National Rosacea Awareness Month, the National Rosacea Society is spotlighting a new classification system for rosacea, which is intended to facilitate the clinical diagnosis of this very common disorder.

The new system identifies the primary features of rosacea as flushing or transient erythema, papules, pustules, and telangiectases. These signs may appear independently, and any one of them is indicative of rosacea. Secondary features of rosacea may include burning or stinging, plaques, a dry appearance, edema, ocular manifestations, and phymatous changes.

The new classification system was recently published in the Journal of the American Academy of Dermatology.

More information about rosacea and National Rosacea Month is available on the National Rosacea Society's Web site at http://www.rosacea.org, or by e-mail at rosaceas@aol.com.

Charlotte LoBuono

TIPS TO REMEMBER: Finacea

  • Patients should avoid using topical cortisones on the face. Do not recommend OTC hydrocortisone to persons with rosacea.

  • Patients should be instructed to avoid spicy foods, thermally hot foods and drinks, and alcoholic beverages.

  • Finacea is contraindicated in persons with a hypersensitivity to propylene glycol.



Charlotte LoBuono. First new treatment for rosacea in a decade to debut.

Drug Topics

2003;4:18.