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Effect of Tecartherapy in the Treatment of Localized Fat and Sagging Abdominal Skin - Clinical and Experimental Study

NCT05020054 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-08-25

No results posted yet for this study

Summary

The excess of localized fat causes changes in the body contour and consequently changes in the properties of the skin and in the connective tissue, providing sagging skin.

Tecartherapy known as High Frequency Capacitive and Resistive Electrical Transfer Therapy (Tecartherapy) emerged to contribute to the treatment of these aesthetic affections, it is a non-invasive electrothermal therapy that acts on cell biostimulation through tissue heating and can help to reduce fat localized and improve the aspect of flaccidity, through the stimulation of neocollagenesis and neoelastogenesis.

This is the aim of this research is to evaluate the effects of Tecartherapy on localized fat and abdominal skin flaccidity with clinical and histological results.

The sample will have 61 participants, who will be evaluated pre and post treatment through evaluation protocols, photographs and questionnaires. The research will have two treatment groups. Being Group 1: Tecartherapy and Group 2: placebo (equipment turned off). 10 Tecartherapy sessions will be held once a week in the abdominal region and flanks. The parameters used will be: for an area of 300cm², 1MHz, Capacitive Mode: 60mm Disk, Default 100W, Time of 10 minutes, keeping temperature up to 42ºC, Resistive Mode: 60mm Disk: Default 110W, Time of 10 minutes, keeping temperature up to 42ºC, with a total treatment time of 20 minutes for the 300cm² area.

After treatment, a biopsy of the subcutaneous tissue and skin will be performed in a volunteer, the tissue will be collected during the surgical procedure of abdominoplasty for histological analysis. The reassessment will be carried out three times, being 30, 60 and 90 days after the initial session, with the repetition of all mentioned exams and photos for analysis of the results, of all participants.

Conditions

  • Fat Disorder
  • Fat Redistribution

Interventions

DEVICE

Tecartherapy Intervention

therapeutic therapy with effective application, connected equipment

DEVICE

placebo tecartherapy

tecartherapy with equipment turned off

Sponsors & Collaborators

  • Indústria Brasileira Equipamentos Médicos - IBRAMED

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-08
Primary Completion
2020-02-10
Completion
2021-07-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05020054 on ClinicalTrials.gov