Status:
TERMINATED
Evaluation Of The Efficacy and Safety Of Tri-ActiveTM In Treatment Of Cellulite
Lead Sponsor:
Hexsel Dermatology Clinic
Conditions:
Cellulite
Body Contouring
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief 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.
Detailed Description
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 ma...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00399828
Start Date
August 1 2006
End Date
November 1 2006
Last Update
March 12 2008
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