This study was conducted at the Siriraj laser center, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand. Twenty Thai females aged more than 20 years with excessive localized subcutaneous fat on the arms or inner thighs were recruited to the study. All subjects had skin phototypes III to V. All subjects received a single session of cryolipolysis treatment (CoolSculpting system; Zeltiq Aesthetics, Pleasanton, CA) on their arms, inner thighs, or both, at Cooling Intensity Factor (CIF) of 41.6 for 60 min followed by 2 min of manual massage on the treated area. A total of 40 areas were treated including 10 arms and 30 inner thighs. All subjects were instructed to adhere to their regular diet, exercise program, and life style with weight fluctuations not exceeding 2 kg from the preceding month. Exclusion criteria included scarring, inflammation or infection of the area to be treated, pregnancy or lactating, subjects with history of malignancy, cold urticaria, Raynaud’s phenomenon, cryoglobulinemia, paroxysmal cold hemoglobinuria, and prior treatment of the area with another body contouring method within 1 year of the baseline visit.
The patients were objectively evaluated using standardized photographs, and measurements of body weight and circumference of arms or inner thighs at baseline, 3-month, and 6-month follow-up visits. Standardized digital photographs using consistent patient positioning, camera angling, and lighting were obtained. Circumference measurements were done using one designated tape measure and were always taken at a consistent distance from an anatomical landmark, superior distance from olecranon process for arm, and superior distance from upper pole of patella for inner thigh, for future site and measurement verification. All measurements were done by the same investigator to avoid possible inter-observer variation.
Patients’ satisfaction survey were also evaluated at 3- and 6-month follow-up by using a quartile grading scale (−1 = worst, 0 = no improvement, 1 = 1–24 % improvement, 2 = 25–49 % improvement, 3 = 50–74 % improvement, 4 = 75–100 % improvement). Side effects were recorded at the treatment session and follow-up visit.
All subjects were instructed to maintain their normal lifestyle, diet, and food consumption during the entire study. No other complimentary treatment including nutritional supplement, mechanical massages, or medication were given to any subjects. This study was approved by the Ethical Committee on Research Involving Human Subjects, Faculty of Medicine, Siriraj Hospital, Mahidol University and conformed to the guidelines of the 1975 Declaration of Helsinki. Written informed consent was obtained from all study subjects.
Descriptive statistics including mean, median, minimum, maximum, percentages of circumferential reduction, and 95 % confidence interval were used to describe demographic data and circumference measurements. The mean differences of body weight and circumferences of arms or inner thighs at baseline, 3-month, and 6-month follow-up visits were analyzed by repeated measure ANOVA. All statistical data analyses were performed using statistical software (SPSS version 16.01; SPSS Inc, Chicago, Illinois).