Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy
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|ClinicalTrials.gov Identifier: NCT03199781|
Recruitment Status : Unknown
Verified June 2017 by Renata Michelini Guidi, Indústria Brasileira Equipamentos Médicos - IBRAMED.
Recruitment status was: Recruiting
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
PURPOSE: To evaluate the efficacy of motorized mechanical massage associated with cosmetics in improving body contour and appearance of gynoid lipodystrophy.
SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be performed in 30 women with localized fat and gynoid lipodystrophy. Patients will be submitted data collection and assessments and before and after treatment.
HYPOTHESES: It is expected that the patients will present improvement in the body contour and in the picture of the gynoid lipodystrophy after the association of the therapies.
STATISTICAL ANALYSIS: A descriptive analysis will be done before and after vibration-oscillatory therapy, with frequency tables for categorical and descriptive variables (mean, standard deviation, median, minimum and maximum values) for continuous or numerical variables. In order to compare the main variables between the groups and the collection times, the analysis of variance (ANOVA) for repeated measurements will be used. Tukey's test will be used to compare groups. The level of significance adopted for the statistical tests will be 5% or p <0.05.
|Condition or disease||Intervention/treatment||Phase|
|Cellulitis of Leg||Device: Motorized mechanical massage with the Dermothonus Slim® Ibramed with cosmetics||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy|
|Actual Study Start Date :||May 30, 2017|
|Estimated Primary Completion Date :||August 20, 2017|
|Estimated Study Completion Date :||September 15, 2017|
Experimental: Intervention of mechanical massage with cosmetics
Patients will be treated with motorized mechanical massage and associated with cosmetics with lipolytic active principle, being performed twice a week totaling 10 sessions by a dermato-functional physiotherapist.
Device: Motorized mechanical massage with the Dermothonus Slim® Ibramed with cosmetics
Patients will be treated with motorized mechanical massage with the Dermothonus Slim® electromedical equipment (Ibramed- Brazilian Industry of Electrical Equipment) associated with cosmetics with lipolytic active principle, being performed twice a week totaling 10 sessions by a dermato-functional physiotherapist.
- Anthropometric evaluation [ Time Frame: Ten minutes ]BMI (kg / height m2)
- Anthropometric evaluation [ Time Frame: Ten Minutes ]Perimeter in the region to be treated in centimeters.
- Evaluation of the degree of cellulite [ Time Frame: Ten minutes ]Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.
- Assessment of adipose tissue thickness [ Time Frame: Twenty minutes ]Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)
- Assessment of skin elasticity [ Time Frame: Twenty minutes ]Evaluation of skin elasticity (Cutometer® MPA580)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199781
|Contact: Renata M Guidifirstname.lastname@example.org|
|Contact: Débora Modenaemail@example.com|
|Ibramed - Indústria Brasileira de Equipamentos Médicos||Recruiting|
|Amparo, São Paulo, Brazil, 13901-080|
|Contact: Débora Modena, MsC 19991319016 firstname.lastname@example.org|
|Contact: Caroline Silva 01938179633 email@example.com|
|Principal Investigator:||Débora modena||University of Campinas, Brazil|