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

Cellulite Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399854
• Other study ID #: 02CBED0501
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2006
• Last updated: November 14, 2006
• Start date: March 2006
• Est. completion date: July 2006

Study information

• Verified date: November 2006
• 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 perform a clinical assessment of the efficacy of the device DHERMIA® (Industra Mecânica Fina Ltda)in the treatment of cellulite and body contouring

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 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 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.

Study Design

Allocation: 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:
• Dhermia® – Industra Mecânica Fina Ltda

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 of the corporal measures
Secondary	Assessment of subject’s satisfaction
Secondary	Visual assessments of the treated area before and after treatment
Secondary	Safety analysis