FDA approves new rosacea treatment
(HealthDay)—A new prescription treatment for the common skin condition rosacea was approved on Monday by the U.S. Food and Drug Administration.
Rosacea is a chronic disease that causes redness and pimples on the skin. In most cases, it affects only the face. Rosacea is most common in women and people with fair complexions, according to the U.S. National Library of Medicine.
The FDA approved Bayer HealthCare's Finacea (azelaic acid) Foam, 15 percent, for treatment of mild to moderate rosacea, Bayer said in a news release.
"According to recent studies, Finacea Foam can help with papules [pimples], pustules [pus-filled bumps] and redness of rosacea," said Dr. Gary Goldenberg, an assistant clinical professor of dermatology at the Icahn School of Medicine at Mount Sinai, in New York City. "This is good news for patients with this chronic condition."
Another expert agreed.
"Azeleic acid has been used for rosacea with excellent results in many patients," said Dr. Doris Day, a dermatologist at Lenox Hill Hospital in New York City. "It's helpful to have options in formulations and concentrations. Having an FDA-approved 15 percent foam concentration will be helpful especially for patients with a specific type of rosacea called the papulo-pustular type, consisting of red bumps and pimples."
The approval is based on the results of two 12-week clinical trials that included more than 1,300 people, aged 19 to 92. The most common side effects of the foam, which is applied to the skin, were localized pain (6.2 percent of patients), itching (2.5 percent), dryness (0.7 percent) and redness of the skin (0.7 percent).
Finacea Foam will be available by prescription only beginning in September, according to Bayer.
There have been a few reports of white spots on the skin after the use of azelaic acid, and doctors should monitor patients with dark complexions for early signs of this problem, Bayer said.
The company also cautioned that azelaic acid can irritate the eyes, and that Finacea Foam should not come into contact with the eyes, mouth or other mucous membranes.
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