March 16, 2009 -- Forehead wrinkles making you frown? A new study shows that injections of a new type of botulinum toxin called Reloxin safely improves moderate-to-severe frown lines and may keep them at bay for more than a year.
Researchers in the U.S. have been investigating Reloxin's potential as a treatment for forehead (glabellar) lines since 2002. According to Reloxin manufacturer Medicis Pharmaceutical, the drug is up for FDA approval this year, possibly in April. If approved, it will go head to head with Botox, the only other such drug approved by the FDA.
Reloxin is already approved as a wrinkle reducer in 23 other countries and has been used abroad for more than 15 years as a treatment for neurological disorders.
Reloxin: Long-Term Safety
The goal of the current study was to determine the long-term safety of multiple injections of Reloxin for the treatment of frown lines. Moy and colleagues also wanted to document how patients responded to Reloxin over many months and to note how long the benefits lasted.
The study involved 1,200 adults, mostly white women about 48 years old, with moderate-to-severe forehead wrinkles.
The study participants received injections of 10 units of Reloxin at five places in the forehead at the beginning of each treatment cycle. Patients received up to five treatments of Reloxin over the 13-month study period, with a minimum 85-day break in between each session.
Patients kept diaries to keep track of their improvement, side effects, or other concerns. The study team called the study participants a week after the injections to ask about side effects. The patients received physical exams at 2 weeks, 30 days, and again every month until their next treatment, withdrawal from the study, or end of the study.