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.
In some cases, wrinkles begin to fade in as soon as 24 hours, Ronald Moy, MD, and colleagues write in the March/April issue of Archives of Facial Plastic Surgery.
Reloxin is a form of Clostridium botulinum toxin type A, similar to Botox (manufactured by Allergan). Botulinum toxin helps erase wrinkles by restricting muscle actions that cause creasing.
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.
Reloxin's Side Effects
The most common side effects reported during the study were events at the injection site, nervous system disorders such as headache, and eye events, including drooping eyelids or eyebrows.
The side effects, however, did not appear bothersome enough to prompt most patients to quit the study. Only one patient dropped out of the study because of an adverse effect. Another person quit the study because the drug did not appear to work, and a few others withdrew for personal reasons. In all, 88% of participants completed the study.
Based on their findings, the study authors say multiple treatments of 50 units of Reloxin is well tolerated and the rate of treatment-related side effects decrease over time. There have been no signs of "cumulative safety issues after more than 4,000 treatments with Reloxin," they write in the journal article.
Reloxin: Benefits Linger
Most patients in the study saw a quick improvement in their frown lines. “The onset of effect was seen as soon as 24 hours and at a [midpoint] of 3 days during all cycles,” the authors write.
- By day 7 of each treatment cycle, 93%-95% of patients saw improvement.
- By day 30, researchers noted fewer frown lines in 80%-91% of patients.
- Multiple treatments seemed to yield effects that lingered for more than 13 months.
Medicis Pharmaceutical Corp. provided funding for this study. Study co-author Corey Maas, MD, owns stock in this company and has consulted for the corporation.