Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy

June 24, 2017 updated by: Renata Michelini Guidi, Indústria Brasileira Equipamentos Médicos - IBRAMED

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Amparo, São Paulo, Brazil, 13901-080
        • Recruiting
        • Ibramed - Indústria Brasileira de Equipamentos Médicos
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric evaluation
Time Frame: Ten minutes
BMI (kg / height m2)
Ten minutes
Anthropometric evaluation
Time Frame: Ten Minutes
Perimeter in the region to be treated in centimeters.
Ten Minutes
Evaluation of the degree of cellulite
Time Frame: Ten minutes
Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.
Ten minutes
Assessment of adipose tissue thickness
Time Frame: Twenty minutes
Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)
Twenty minutes
Assessment of skin elasticity
Time Frame: Twenty minutes
Evaluation of skin elasticity (Cutometer® MPA580)
Twenty minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indústria Brasileira Equipamentos Médicos - IBRAMED

Investigators

  • Principal Investigator: Débora modena, University of Campinas, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2017

Primary Completion (Anticipated)

August 20, 2017

Study Completion (Anticipated)

September 15, 2017

Study Registration Dates

First Submitted

May 19, 2017

First Submitted That Met QC Criteria

June 24, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 24, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ibramed

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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