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Botox Alternative Found to Be Safe, Effective

Posted: March 17, 2009

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In this phase III trial, Reloxin's wrinkle-smoothing effects lasted more than 13 months. And although the drug is still awaiting approval from the U.S. Food and Drug Administration, it could someday become a serious competitor to Botox, the researchers said.

"Reloxin is as safe and it works as well as Botox," said lead researcher Ronald Moy, MD, from the Moy-Fincher Medical Group in Los Angeles. "Many of our patients are happier and got a more natural look with the use of Reloxin. I think this will be as popular as Botox, which is the most common cosmetic procedure in the United States."

But not all plastic surgeons are as enthusiastic, with some citing a heightened incidence of drooping of the eyelid and/or brow with Reloxin vs. Botox. "With this study, I don't see a clear advantage over Botox," said Jeffrey C. Salomon, MD, an assistant clinical professor of plastic surgery at Yale University School of Medicine.

The report, which was funded by the drug's maker, Medicis Pharmaceutical Corp., is published in the March/April issue of the Archives of Facial Plastic Surgery. For the study, Moy's team treated 1,200 patients with injections of Reloxin (Clostridium botulinum toxin type A-hemagglutinin complex) in five sites in the forehead. Patients kept diaries of the effects of the treatment and were surveyed a week to 10 days after treatment. In addition, patients were reexamined two weeks and 30 days later, and then each month after treatment.

Among the 1,052 patients who completed the 13-month study, there were 2,838 adverse events among 880 patients. Of these, 28% were probably related to the treatment. These included problems at the injection site, nervous system disorders such as headache and eye problems including ptosis, a drooping of the eyelid or brow. Only one patient withdrew from study due to the side effects of the drug, the researchers say.