evaluation of the efficacy and safety of tri-activetm in treatment of cellulite

Conditions: Cellulite; Body Contouring

Summary: the purpose of this study is to assess the efficacy of device tri-activetm (deka m.e.l.a., itália)in the treatment od cellulite and body contouring.

the present study is a clinical, opened trial and single-center. the patients will be treated by six laser diodes, localised cooling system and rhythmical intake massage device. application of the massage will be performed for 8 weeks in a total of 16 treatment sessions: twice a week. a set of photographs will be taken at visit 1 (baseline), visit 2 and 3 with standardized positions and lighting conditions.

Eligibility criteria:
inclusion criteria: 1. written informed consent; 2. subjects agreeing to take part of all procedures of the study (including mechanical massage, photographs), after being fully informed on the objectives and nature of the investigations; 3. female subjects between 18-45 years; 4. subjects presenting with cellulite grades i-iii on buttocks and thighs; 5. medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the device under investigation; 6. female subjects of childbearing age should present a negative urine pregnancy test and should be using an effective contraceptive method (3 months before the enrollement untill the end of the study); 7. body mass index (bmi = weight/height2) beetwen 20,0-25,0; 8. availability of the subject throughout the duration of the study (60 days); 9. availability of the subject in maintaining a stable weight during the study (variation less than 2 kg) 10. subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol. exclusion criteria: 1. pregnant women or women intending to become pregnant during the study (next 3 months); 2. bmi superior 25,0; 3. subjects with diabetes mellitus, cardiac insufficiency, asthma, or bronchitis; 4. subjects participating in other clinical trials; 5. subjects with neoplastic disorders, uncontrolled thyroid disorders or uncontrolled hypertension; 6. subjects with coagulation disorders, using anticoagulants or tendency of bruises; 7. subjects with vascular disorders (phlebitis or varicose veins) in the area to be treated; 8. any prior aesthetic surgery affecting the area to be treated (liposuction, subcision®), 3 months before the study, that may interfere with results; 9. any other prior anti-cellulite treatment or body measures treatment, 30 days prior to the study; 10. subjects with inflammation or active infection in the area to be treated. 11. subjects with a history of adverse effects, which in the investigator's opinion should prevent the patient from participating in the study; 12. patients with cutaneous or vascular alterations, that difficult visualization and documentation of cellulite; 13. subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol; 14. subjects who can not come to the visits (one missing visit/ month is allowed); 15. subjects intending to initiate any intensive sport; 16. subjects using analgesics, non-hormonal antiinflammatories, antihistaminics, corticosteroids, or diuretics; 17. subjects tanned, or intending to expose the area of study to sun, artificial uv, or self-tanning during the study; 18. any condition that, in the opinion of the investigator, can compromise the evaluation of the study.