Evaluation of the Efficacy of Endermologie in Treatment of Cellulite and Body Contouring

NCT ID: NCT00399854

Last Updated: 2006-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2006-07-31

Brief Summary

The purpose of this study is to perform a clinical assessment of the efficacy of the device DHERMIA® (Industra Mecânica Fina Ltda)in the treatment of cellulite and body contouring

Detailed Description

The present study is a clinical, opened trial and single-center.

The patients were treated by endermologie device. Mechanical massage were performed for 12 weeks in a total of 24 treatment sessions: twice a week.

A set of photographs were took at visit 1 (baseline), visit 2, 3 and 4 with standardized positions and lighting conditions.

Conditions

Cellulite; Body Contouring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Dhermia® - Industra Mecânica Fina Ltda

Intervention Type: DEVICE

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 25-45 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 and 25,0-29,9;

8. Availability of the subject throughout the duration of the study (90 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 30,0;

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brazilan Center for Studies in Dermatology

OTHER

Sponsor Role: lead

Principal Investigators

Doris Hexsel, MD

Role: STUDY_DIRECTOR

Brazilan Center for Studies in Dermatology

Other Identifiers

02CBED0501

Identifier Type: -

Identifier Source: org_study_id