Evaluation Of The Efficacy and Safety Of Tri-ActiveTM In Treatment Of Cellulite

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Study For Evaluation Of The Efficacy and Safety Of Tri-ActiveTM (Deka M.E.L.A., Itália) In Treatment Of Cellulite

Conditions
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Cellulite, Body Contouring

Intervention / Treatment
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* Device: TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written Informed Consent; 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; Female subjects between 18-45 years; Subjects presenting with cellulite grades I-III on buttocks and thighs; 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; 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); Body Mass Index (BMI = weight/height2) beetwen 20,0-25,0; Availability of the subject throughout the duration of the study (60 days); Availability of the subject in maintaining a stable weight during the study (variation less than 2 kg) Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol. Exclusion Criteria: Pregnant women or women intending to become pregnant during the study (next 3 months); BMI superior 25,0; Subjects with diabetes mellitus, cardiac insufficiency, asthma, or bronchitis; Subjects participating in other clinical trials; Subjects with neoplastic disorders, uncontrolled thyroid disorders or uncontrolled hypertension; Subjects with coagulation disorders, using anticoagulants or tendency of bruises; Subjects with vascular disorders (phlebitis or varicose veins) in the area to be treated; Any prior aesthetic surgery affecting the area to be treated (liposuction, Subcision®), 3 months before the study, that may interfere with results; Any other prior anti-cellulite treatment or body measures treatment, 30 days prior to the study; Subjects with inflammation or active infection in the area to be treated. Subjects with a history of adverse effects, which in the investigator's opinion should prevent the patient from participating in the study; Patients with cutaneous or vascular alterations, that difficult visualization and documentation of cellulite; Subjects with a history of medical treatment non-adherence or showing unwillingness to adhere to the study protocol; Subjects who can not come to the visits (one missing visit/ month is allowed); Subjects intending to initiate any intensive sport; Subjects using analgesics, non-hormonal antiinflammatories, antihistaminics, corticosteroids, or diuretics; Subjects tanned, or intending to expose the area of study to sun, artificial UV, or self-tanning during the study; Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of effectiveness of treatment based on current classification of cellulite and evaluation corporal measures |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of subject's satisfaction |  |  | 
| Visual assessments of the treated area before and after treatment |  |  | 
| Safety analysis |  |  |