Botulinum Drug for Wrinkles Found Well-Tolerated

Possible adverse effects include injection-site issues and headaches

WEDNESDAY, March 18 (HealthDay News) -- The use of a botulinum toxin type A product (Reloxin) appeared to be well-tolerated and effective after repeated treatments, according to research published in the March/April Archives of Facial Plastic Surgery.

Ronald Moy, M.D., of the Moy-Fincher Medical Group in Los Angeles, and colleagues analyzed data from 1,200 patients, 90 percent female, who underwent up to five Reloxin treatments with at least 85 days between treatments. The primary endpoint of the study was the safety of the drug.

Adverse events that were possibly or probably related to the treatment occurred in 36 percent of subjects, the report indicates. The most common of these adverse events were injection-site issues in 18 percent, nervous system disorders (mostly headache) in 14 percent and eye-related events in 9 percent. Most adverse events around the injection sites or the eyes resolved within three weeks in all the cycles. Response rates, assessed by glabellar line severity scores, ranged from 80 to 91 percent across the five cycles, the researchers report.

"By every measure -- investigators' and patients' assessments of glabellar lines at maximum frown, the onset of effect, and the duration of effect -- Reloxin demonstrated an efficacy that did not diminish with repeated treatments. The onset of effect was seen as soon as 24 hours and at a median of three days during all cycles," the authors write.

Medicis Pharmaceutical Corp, the maker of the drug, provided Reloxin and funding for the study; a co-author disclosed financial relationships with the company.

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