March 16, 2009 — Forehead wrinkles making you frown? A new study shows thatinjections of a new type of botulinum toxin called Reloxin safely improvesmoderate-to-severe frown lines and may keep them at bay for more than ayear.
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 FacialPlastic Surgery.
Reloxin is a form of Clostridium botulinum toxin type A, similar toBotox (manufactured by Allergan). Botulinum toxin helps erase wrinkles byrestricting muscle actions that cause creasing.
Researchers in the U.S. have been investigating Reloxin’s potential as atreatment for forehead (glabellar) lines since 2002. According to Reloxinmanufacturer 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 onlyother such drug approved by the FDA.
Reloxin is already approved as a wrinkle reducer in 23 other countries andhas been used abroad for more than 15 years as a treatment for neurologicaldisorders.
Reloxin: Long-Term Safety
The goal of the current study was to determine the long-term safety ofmultiple injections of Reloxin for the treatment of frown lines. Moy andcolleagues also wanted to document how patients responded to Reloxin over manymonths and to note how long the benefits lasted.
The study involved 1,200 adults, mostly white women about 48 years old, withmoderate-to-severe forehead wrinkles.
The study participants received injections of 10 units of Reloxin at fiveplaces in the forehead at the beginning of each treatment cycle. Patientsreceived up to five treatments of Reloxin over the 13-month study period, witha minimum 85-day break in between each session.
Patients kept diaries to keep track of their improvement, side effects, orother concerns. The study team called the study participants a week after theinjections to ask about side effects. The patients received physical exams at 2weeks, 30 days, and again every month until their next treatment, withdrawalfrom the study, or end of the study.
Reloxin’s Side Effects
The most common side effects reported during the study were events at theinjection 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 mostpatients to quit the study. Only one patient dropped out of the study becauseof an adverse effect. Another person quit the study because the drug did notappear to work, and a few others withdrew for personal reasons. In all, 88% ofparticipants completed the study.
Based on their findings, the study authors say multiple treatments of 50units of Reloxin is well tolerated and the rate of treatment-related sideeffects decrease over time. There have been no signs of “cumulative safetyissues after more than 4,000 treatments with Reloxin,” they write in thejournal 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 daysduring 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 13months.
Medicis Pharmaceutical Corp. provided funding for this study. Studyco-author Corey Maas, MD, owns stock in this company and has consulted for thecorporation.