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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00399828
Other study ID # 02CBED0602
Secondary ID
Status Terminated
Phase Phase 4
First received November 14, 2006
Last updated March 11, 2008
Start date August 2006
Est. completion date November 2006

Study information

Verified date March 2008
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 assess the efficacy of device TRI-ACTIVETM (DEKA M.E.L.A., Itália)in the treatment od cellulite and body contouring.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 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 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália)


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 corporal measures
Secondary Assessment of subject's satisfaction
Secondary Visual assessments of the treated area before and after treatment
Secondary Safety analysis
See also
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Completed NCT05026216 - To Assess the Effectiveness of Multiple Dose, Multiple Concentrations of Qwo, for the Treatment of Mild to Moderate Cellulite. Phase 4
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