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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
Sponsor:
Information provided by (Responsible Party):
Renata Michelini Guidi, Indústria Brasileira Equipamentos Médicos - IBRAMED

Brief Summary:

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

Detailed Description:
After signing the informed consent, the participants will be evaluated by two physiotherapists where the data collected will be from personal data, anthropometric and complementary diagnostic tests such as: ultrasound diagnosis in order to evaluate the thickness of the adipose tissue and Cutomiter analysis of the Viscoelasticity of the skin. Afterwards they will be divided and started the treatment with another physiotherapist who will perform the following protocol of the study: exfoliation of the skin, application of the motorized mechanical massage with the device Dermotonus Slim with 550mg of vacuum, continuous mode, for 20 minutes subdivided into region Abdominal and posterior thigh, after the end will be applied the creams for lipolytic purposes. The protocol will be performed twice a week for 1 hour each, totaling 10 sessions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Anthropometric evaluation [ Time Frame: Ten minutes ]
    BMI (kg / height m2)

  2. Anthropometric evaluation [ Time Frame: Ten Minutes ]
    Perimeter in the region to be treated in centimeters.

  3. Evaluation of the degree of cellulite [ Time Frame: Ten minutes ]
    Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.

  4. Assessment of adipose tissue thickness [ Time Frame: Twenty minutes ]
    Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)

  5. Assessment of skin elasticity [ Time Frame: Twenty minutes ]
    Evaluation of skin elasticity (Cutometer® MPA580)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female gender, over 18 years of age;
  • With a body mass index up to 29.9 considered overweight;
  • Carriers of GI lipodystrophy;
  • Non smokers;
  • That they agree to participate and sign the term of free and informed commitment - TCLE

Exclusion Criteria:

  • Male gender;
  • Performed esthetic treatment in the gluteal region and thighs in the last month;
  • Patients with skin lesions, such as dermatitis and dermatoses;
  • Patients with capillary fragility;
  • Patients with acute deep vein thrombosis (DVT);
  • On or near cancerous lesions;
  • Patients with cardiac pacemaker or other implanted electronic device.

Information from the National Library of Medicine

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


Contacts
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Contact: Renata M Guidi 38179633 re_guidi@yahoo.com.br
Contact: Débora Modena 019991319016 de_modena@yahoo.com.br

Locations
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Brazil
Ibramed - Indústria Brasileira de Equipamentos Médicos Recruiting
Amparo, São Paulo, Brazil, 13901-080
Contact: Débora Modena, MsC    19991319016    de_modena@yahoo.com.br   
Contact: Caroline Silva    01938179633    de_modena@yahoo.com.br   
Sponsors and Collaborators
Indústria Brasileira Equipamentos Médicos - IBRAMED
Investigators
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Principal Investigator: Débora modena University of Campinas, Brazil

Publications of Results:
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Responsible Party: Renata Michelini Guidi, Principal Investigator, Indústria Brasileira Equipamentos Médicos - IBRAMED
ClinicalTrials.gov Identifier: NCT03199781     History of Changes
Other Study ID Numbers: Ibramed
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Renata Michelini Guidi, Indústria Brasileira Equipamentos Médicos - IBRAMED:
cellulits of leg
Motorized power massage
massage
Additional relevant MeSH terms:
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Cellulitis
Lipodystrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes