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

Last updated: November 14, 2006
Sponsor: Brazilan Center for Studies in Dermatology
Overall Status: Completed

Phase

4

Condition

Liposuction

Treatment

N/A

Clinical Study ID

NCT00399854
02CBED0501
  • Ages 25-45
  • Female
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written Informed Consent;

  2. Subjects agreeing to take part of all procedures of the study (including mechanicalmassage, photographs), after being fully informed on the objectives and nature of theinvestigations;

  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 underinvestigation;

  6. Female subjects of childbearing age should present a negative urine pregnancy test andshould be using an effective contraceptive method (3 months before the enrollementuntill 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 (variationless than 2 kg)

  10. Subjects with sufficient schooling and awareness to enable them to cooperate to thedegree required by this protocol.

Exclusion

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 uncontrolledhypertension;

  6. Subjects with coagulation disorders, using anticoagulants or tendency of bruises;

  7. Subjects with vascular disorders (phlebitis or varicose veins) in the area to betreated;

  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 tothe 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 shouldprevent the patient from participating in the study;

  12. Patients with cutaneous or vascular alterations, that difficult visualization anddocumentation of cellulite;

  13. Subjects with a history of medical treatment non-adherence or showing unwillingness toadhere 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, orself-tanning during the study;

  18. Any condition that, in the opinion of the investigator, can compromise the evaluationof the study.

Study Design

Total Participants: 45
Study Start date:
March 01, 2006
Estimated Completion Date:
July 31, 2006

Study 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.