Evaluation Of The Efficacy and Safety Of Tri-ActiveTM In Treatment Of Cellulite
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.
Device: TRI-ACTIVE LASERDERMOLOGYTM (DEKA M.E.L.A., Itália)
|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|
- Assessment of effectiveness of treatment based on current classification of cellulite and evaluation corporal measures
- Assessment of subject's satisfaction
- Visual assessments of the treated area before and after treatment
- Safety analysis
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||November 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399828
|Study Director:||Doris Hexsel||Brazilian Center fpr Dermatological Studies|