New type of botulinum may smoothen wrinkled foreheadMarch 17th, 2009 - 3:13 pm ICT by IANS
Washington, March 17 (IANS) A new type of botulinum toxin may smoothen moderate to severe forehead wrinkles, according to a new study.
Injecting low doses of Clostridium botulinum toxin type A (Reloxin) is a method in vogue for treating lines on the face. It has been used to treat neurological disorders outside US for more than 15 years and is approved to treat wrinkles in 23 countries.
In US, this product has been under investigation for the treatment of forehead lines since 2002, according to the authors.
Ronald Moy, Moy-Fincher Medical Group, Los Angeles, and colleagues report data from a phase III, open-label study of 1,200 patients. Investigators injected 0.05 ml of solution, each containing 10 units of the new botulinum toxin, into each of five injection sites in the forehead at the beginning of each treatment cycle.
Patients maintaining diaries of treatment effects, were telephoned seven days later to check for adverse events and were re-examined clinically after two weeks, 30 days and again every month until their next treatment, withdrawal from the study or the end of the study.
Based on patient response, as many as five consecutive treatments were given with a minimum of 85 days in between.
A total of 1,052 patients completed the 13-month study. During the study period, 2,838 adverse events were experienced by 880 patients.
Of those, 804 (28 percent) were considered probably or possibly related to the treatment, including events at the injection site (18 percent), nervous system disorders (14 percent) such as headache (12 percent) and eye events (nine percent, including four percent with ptosis, drooping of the eyelid or brow). Only one patient discontinued the study because of adverse events.
The authors suggest that based on investigators’ and patients’ assessments, the onset of effect and the duration of effect, the new botulinum toxin type A demonstrated benefits that did not diminish with repeat treatments, said a Journal of American Medical Association (JAMA) release.
The study was published in the March/April issue of Archives of Facial Plastic Surgery, a JAMA journal.
Tags: adverse events, botulinum toxin type, brow, clostridium botulinum toxin, fincher, forehead lines, forehead wrinkles, march 17, medical group, nervous system disorders, neurological disorders, patient response, period 2, phase iii, ptosis, reloxin, ronald moy, study period, vogue, wrinkled forehead