Cryolipolysis treatment for subcutaneous fat layer reduction
Macedo, OR; Matayoshi, L; Matsumoto, LHI; Tsuge, LY
Introduction:
Recent studies indicate that fat cells are more susceptible to cold than other types of cells1,2. The controlled exposure of adipocytes to cold can decrease the viability of fat cells with loss of a substantial volume of subcutaneous fat and without affecting surrounding structures3,4. This new technology of energy extraction results in a localized lobular panniculitis that proceeds for many weeks following a single, local exposure to cold, reaching an apparent maximum around 4 weeks and having resolved about 3 months after cold exposure5 and leads to modulation of fat. Therefore, the controlled extraction of heat may be used as a non-invasive approach to reducing the superficial fat layer.
Methods:
Individuals eligible for inclusion in this trial were men or women ranging between 20 and 65 years of age with visible fat on the flanks (“love handles”) or abdomen; the method excluded obese or subjects who had general or amorphous fat. All the subjects provided informed written consent under an institutional review board-approved protocol.
Exclusion criteria were if they had recently undergone liposuction or another surgical procedure, had a history of subcutaneous injections into the area of intended treatment within the preceding 6 months, or had a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
A hundred patients were submitted to a single cryolipolysis procedure and were followed at pre-procedure, 2, 4 and 6 months after procedure with standard photographs taken with Camfield Digital System and subject standard satisfaction report form.
Results – Subject Form Report:
90% of the patients completed a standard report form at 2, 4 and 6 months after the procedure. 50% of the patients reported a significant improvement of body contour and were happy with the results of their treatment at 6 months. About 20% of the patients felt they needed another session of treatment or would like to treat another area.
Clinically there was a significant improvement in reduction of fat (70%) and there was a skin tightening (not expected) in 20% of pacients.
Results – Subject Discomfort Assessment:
Subjects provided feedback about the level of discomfort they felt during the procedure. 50% indicated they had minor discomfort during the procedure; 30% indicated they felt a level of discomfort greater than they expected during the procedure, but well tolerated; 20% reported no discomfort at all. There were no cases of non-tolerance to the procedure.
2 months after procedure follow-up, 60% of the subjects experienced transient bruising (edema, minor pain, erythema), which was well-tolerated and fully resolved. 10% of the subjects reported local numbness and minor pain that lasted for about 2 weeks. At the 4 and 6 months follow-up, none of the patients reported side-effects of the procedure.
Conclusion:
The Cryolipolysis treatment causes substantial reduction of subcutaneous fat volume and changes in the contour of the treated area without damage to the skin.
The current results support the conclusion that the exposure to cold sufficient to achieve significant cryolipolysis is a safe, non-invasive procedure not associated with relevant side effects.
Additional studies may further characterize the cryolipolysis effects in long-term period.
References
Donski PK, Franklin JD, Hurley JV, O’Brien BM. The effects of cooling on experimental free flap survival. Br J Plast Surg. 1980;33:353-360.
Coban YK, Kurutas EB, Ciralik H. Ischemia-reperfusion injury of adipofascial tissue: an experimental study evaluating early histologic and biochemical alterations in rats. Mediator Inflamm. 2005;304-308.
Lidagoster MI, Cinelli PB, Leveé EM, Sian CS. Comparison of autologous fat transfer in fresh, refrigerated, and frozen specimens: na animal model. Ann Plast Surg. 2000;44:512-515.
Wolter TP, von Heimburg D, Stoffels I, Groeger A, Pallua N. Cryopreservation of mature human adipocytes: in vitro measurement of viability. Ann Plast Surg. 2005;55:408-413.
Manstein D, Laubach H, Watanabe K, Farinelle W, Zurakowski D, Anderson RR. Selective Cryolysis: A Novel Method of Non-Invasive Fat Removal. Lasers Surg Med. 2008;40:595-604.