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

Cellulite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00399828
• Other study ID #: 02CBED0602
• Status: Terminated
• Phase: Phase 4
• First received: November 14, 2006
• Last updated: March 11, 2008
• Start date: August 2006
• Est. completion date: November 2006

Study information

• Verified date: March 2008
• Source: Brazilan Center for Studies in Dermatology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: November 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Contouring
• Cellulite

Intervention

Device:
• TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brazilan Center for Studies in Dermatology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of effectiveness of treatment based on current classification of cellulite and evaluation corporal measures
Secondary	Assessment of subject's satisfaction
Secondary	Visual assessments of the treated area before and after treatment
Secondary	Safety analysis