Reduction of subcutaneous fat and improvement in cellulite appearance by medical fibers

Keywords:medical, fibers, laser, fibers,  Time:04-01-2016

Among those who completed the study, 82.26% responded to treatment. Individuals reported looser-fitting clothing and satisfaction with the procedure and results. Adverse effects were limited to occasional increases in urinary frequency. Conclusion: Low-level, dual-beam laser energy with massage appears to be safe and more efficacious than massage alone for reducing subcutaneous fat in the thighs of normal women.

Introduction

Although not considered a specific disease, cellulite is of major cosmetic concern, especially to postpubertal women. Patients typically present with dimpling of the skin in the thighs and buttocks (1), and their skin resembles cottage cheese or the external surface of orange peel. The appearance of cellulite is believed to be due to hormonally mediated fat deposition, compression of capillary vasculature by fat lobules, reduced venous return, development of clumped fat lobules, and deposition of proteins around clumped fat lobules (2). In addition to the thighs and buttocks, cellulite may occur in the breast, upper arms, lower abdomen, and other areas of subcutaneous adipose deposition. The condition is found in slim as well as obese individuals, can be accentuated by excess weight, and is very prevalent in adult women (3,4). A variety of methods have been advocated for improving the appearance of cellulite. Modalities liposuction (7–10); ultrasound- and laser-assisted liposuction (10,11); massage-suction and skin kneading by mechanical device using Endermologie (LPG Systems, Valence, France) (12); 810-nm diode laser energy with cooling and mechanical massage (13,14); infrared light (700– 2000 nm) with radiofrequency (RF) and suctionbased massage (13,15–17); RF (18); mesotherapy and injection lipolysis (19,20); topical aminophylline (21,22) and retinol (23); and botanical extracts (24). Numerous nutritional supplements are also touted as beneficial for the reduction or elimination (or both) of cellulite and fat. Current light-based technologies are potentially destructive, use wavelengths not specific to lipids, deliver disappointing short-term improvements, and have not been shown to induce metabolic activity to restore affected tissue to its pre-cellulite state. Scientific support for their efficacies is anecdotal and based on subjective criteria for assessing response to treatment (4).

This study compares the efficacy and safety of low-level, dual-wavelength laser energy and massage with massage alone for the reduction of subcutaneous fat in the thighs of 102 individuals. This device is a prototype of the SmoothShapes TM system (Eleme´Medical,Merrimack,NH,USA),clearedby the FDA for the temporary reduction in the appearance of cellulite.

Materials and methods

Healthy female volunteers (n5102) aged 18–50 years (40¡7.6) with identifiable trochanteric fat pads enrolled in an IRB-approved study conducted at the University of Massachusetts Medical School in Worcester, MA and at the Beth Israel Deaconess Medical Center, an affiliate hospital of Harvard Medical School in Boston, MA. The women were no more than 15% overweight as determined by body mass index (BMI), reported stable weight and clothing size measurements during the previous 6 months, and were required to maintain baseline food and activity patterns during the study period. They underwent a complete history and physical examination which included weight, height, smoking status, drug regimens (particularly diabetic and weight loss), heart rate, and blood pressure. Cardiovascular, abdominal, neurological and cutaneous findings were noted. Cellulite distribution and texture were estimated subjectively by clinical observation and objectively by photography and circumference measurements (hip, buttocks, and thigh) at sites referenced to anatomical landmarks. Magnetic resonance imaging (MRI) images were obtained for all patients in multiplanar planes using standardized techniques followed by cross-sectional pixel quantification of the respective structural constituents of the thigh. Individuals undergoing treatment of hypertension or diabetes obtained clearance to participate from their primary physicians. Pregnancy, a tattoo or suntan in areas to be treated, undergoing steroid or immunosuppressant therapy, claustrophobia, MRIsensitive implanted medical devices, and a history of deep vein thrombosis were grounds for exclusion. All the women signed an informed consent to participation in accordance with the IRB-approved study.

Treatment

Medical Fibers Treatments were planned to avoid the premenstrual part of the cycle. Thighs of subjects were randomized to treatment with either a combination of scanning laser (concentric 650¡20 nm at 0.5 W and 915¡10 nm at 1 W) and massage, or with massage alone. The thigh treated with massage alone served as a control for each individual. For every treatment, thighs were divided into three circumferential segments, each of which received multiple transverse or longitudinal passes to ensure full coverage of the entire thigh and lower buttock. Each session lasted approximately 40 minutes. A trained, physician-supervised technician administered the medical fibers treatments. The individuals received a mean of 14.3 treatments, one to three per week, over 4–6 weeks. For those who failed to keep appointments, up to 20 treatments were given; this subgroup received an average of three treatments every 2 weeks. Individuals were blinded as to the treatment of each thigh. After laser light exposure, both thighs were manually massaged 10 times. The direction of the massage was always from distal to proximal in a longitudinal direction. A kneading motion and vigorous friction mechanical techniques (effleurage and petrissage) were alternated. MRI scans quantified the dimensions of fat pads before the start of treatments and after the final treatment and were interpreted by a blinded independent radiologist. Scans were digitized and pixel counts of the respective fat, muscle, bone, and skin layers were separated and calculated in order to determine a relative density of fat as measured in each two-dimensional axial image. Clinical examples are shown in Figures 1–3. Skin surfaces were analyzed by digital photography (Figure 4). Measurements of thigh circumference were made at biweekly visits while neurological and peripheral vascular exams were made at the midpoint and at the end of the study. All participantreported adverse effects were documented at each session. At an exit interview following all treatment sessions, each individual was asked to report on the presence or absence of pain or tingling during treatment, changes in urinary habits, and on skin turning red or otherwise.

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Results

Among the 65 individuals who had both pre- and posttreatment MRI measurements (Table I), the fat thickness decreased over time by 1.19 cm2 (mean) for the leg treated by laser-massage and increased by 3.82 cm2 (mean) for the leg treated by massage alone.