KISSIMMEE, FLA. – Single noninvasive treatments with a prototype 1,060-nm diode laser led to statistically significant, visually discernible reductions of adipose tissue covering the abdomen and flanks in two prospective multicenter studies.
“The treatment is well tolerated, with only mild and transient side effects,” said Dr. Bruce Katz of Mount Sinai School of Medicine in New York, who presented the results of the flank study at the annual meeting of the American Society for Laser Medicine and Surgery.
Most patients were “satisfied” or “very satisfied” with the results, added Dr. Sean Doherty, a plastic surgeon in group practice in Boston, who presented the results of the abdominal study.
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Noninvasive fat reduction procedures rose 43% in the past year, said Dr. Doherty. The 1,060-nm diode laser damages adipocytes in targeted areas, eventually resulting in apoptosis, he added. Sessions in both studies lasted 25 minutes, with irradiance at 0.9-1.4 W/cm2 and treatment areas of 48-144 cm2 for the flanks and 192-288 cm2 for the abdomen, the investigators said.
The abdominal study included 34 patients, and the flank study included 42 patients. Investigators treated only one side for each patient in the flank study, reserving the other as a “sham” or control, Dr. Katz said. A blinded review of photographs taken before and 12 weeks after the procedures served as the primary endpoint in both studies. Assessors correctly identified an average of 95% of “before” photographs of the abdomen and 90.3% of those of the flank, Dr. Doherty and Dr. Katz reported.
The secondary endpoint was change in thickness of the adipose layer at 12 weeks post procedure, as measured by ultrasound. The average reduction was 3.1 mm for the abdomen (standard deviation, 1.7 mm) and 2.6 mm for the flank (standard deviation not reported; P < .001 for both), the researchers said. In the abdominal study, 85% of patients said they were “satisfied” or “extremely satisfied” with the results, while 6% were “slightly satisfied,” Dr. Doherty said. In the flank study, 86% of patients said they were “satisfied” or “extremely satisfied,” while 10% were “slightly satisfied.”
Mean pain scores were 3.7 out of 10 for the abdominal procedure and 4.0 out of 10 for the flank procedure. The most common side effect was mild to moderate tenderness that usually subsided within about 2 weeks of treatment. Other side effects included localized firmness, edema, and ecchymosis. No patients had serious adverse effects, the researchers said.
Most of the patients were approximately 45-49 years of age. Those in the abdominal study had an average body mass index of 25.5 kg/m2, while those in the flank study averaged 26.4 kg/m2, the researchers reported. Most of the patients in both studies were women (94% of abdominal patients and 86% of flank patients).
The average weight gain at 12 weeks for the abdominal study was 0.1 pounds (range, –5.2 to 5.6 pounds), while patients in the flank study gained an average of 0.8 pounds (range, –0.7 to 13 pounds), the researchers noted. Six patients in the flank study gained more than 5 pounds, and one gained more than 37 pounds and was therefore excluded from the efficacy analysis, Dr. Katz noted.
The researchers did not report funding sources for the studies. They disclosed advisory and financial relationships with Allergan, Merz Pharmaceuticals, Cynosure, Valeant, Syneron, and several other pharmaceutical companies.