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

This study has been terminated.
Sponsor:
Information provided by:
Brazilan Center for Studies in Dermatology
ClinicalTrials.gov Identifier:
NCT00399828
First received: November 14, 2006
Last updated: March 11, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Cellulite
Body Contouring
Device: TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-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 and Safety Of Tri-ActiveTM (Deka M.E.L.A., Itália) In Treatment Of Cellulite

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 corporal measures

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

Estimated Enrollment: 20
Study Start Date: August 2006
Estimated Study Completion Date: November 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399828

Sponsors and Collaborators
Brazilan Center for Studies in Dermatology
Investigators
Study Director: Doris Hexsel Brazilian Center fpr Dermatological Studies
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00399828     History of Changes
Other Study ID Numbers: 02CBED0602
Study First Received: November 14, 2006
Last Updated: March 11, 2008
Health Authority: Brazil: National Committee of Ethics in Research

ClinicalTrials.gov processed this record on April 22, 2014