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

This study has been completed.
Sponsor:
Information provided by:
Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:
NCT00399854
First received: November 14, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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


Condition Intervention Phase
Cellulite
Body Contouring
Device: Dhermia® – Industra Mecânica Fina Ltda
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study for Evaluation of the Efficacy of Mechanical Massage by Endermologie (Dhermia® – Industra Mecânica Fina Ltda) in Treatment of Cellulite and Body Contouring

Further study details as provided by Brazilan Center for Studies in Dermatology:

Primary Outcome Measures:
  • Assessment of effectiveness of treatment based on current classification of cellulite and evaluation of the corporal measures

Secondary Outcome Measures:
  • Assessment of subject’s satisfaction
  • Visual assessments of the treated area before and after treatment
  • Safety analysis

Estimated Enrollment: 45
Study Start Date: March 2006
Estimated Study Completion Date: July 2006
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.

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399854

Sponsors and Collaborators
Brazilan Center for Studies in Dermatology
Investigators
Study Director: Doris Hexsel, MD Brazilan Center for Studies in Dermatology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00399854     History of Changes
Other Study ID Numbers: 02CBED0501
Study First Received: November 14, 2006
Last Updated: November 14, 2006
Health Authority: Brazil: National Committee of Ethics in Research

ClinicalTrials.gov processed this record on August 21, 2014