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

Primary Purpose

Fat Disorder, Fat Redistribution

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Tecartherapy Intervention
placebo tecartherapy
Sponsored by
Indústria Brasileira Equipamentos Médicos - IBRAMED
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fat Disorder focused on measuring fat disorder, fat redistribution

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • participants must be aged between 30 and 45 years of age.
  • body mass index considered normal or overweight 18.5 to 29.9.
  • sedentary.
  • with fat located above 1.5cm and sagging abdominal skin.
  • which cannot be under other aesthetic treatments for the same purpose.
  • must have preserved local understanding and sensitivity.

Exclusion Criteria:

  • participants who present alteration in sensitivity.
  • who have contraindications for the use of the therapeutic resource used in the research, which are:
  • Electronic device implanted as a cardiac pacemaker;
  • Large metallic implant in the treated area;
  • Pregnant patients;
  • Patients with venous insufficiency of the lower limbs;
  • About neoplastic areas;
  • Osteoporosis;

Sites / Locations

  • Ibramed - Indústria Brasileira de Equipamentos Médicos

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention Tecartherapy

Placebo Tecartherapy

Arm Description

The procedures will be performed with Tecartherapy equipment, with the equipment Nèartek®- IBRAMED- Industria Brasileira de Equipamentos Eletromédicos. The treatment will be carried out once a week, totaling 10 sessions, by two dermato-functional physiotherapists. During the sessions, all volunteers will be positioned in dorsal decubitus and the applicator positioned in the abdominal region, the therapy will be dynamic and simultaneously the professional must assess the local temperature. The parameters used will be: Area of 300cm², 1MHz, Capacitive Mode: 60mm Disc: Default 100W Time of 10 minutes, keeping temperature at 42°C Resistive Mode: 60mm Disc: Default 110W Time of 10 minutes, keeping temperature at 42ºC. The total treatment time is 20 minutes.

the therapy took place with the equipment turned off

Outcomes

Primary Outcome Measures

Immunohistochemical procedures
Immunohistochemical reactions were performed on 3μm-thick sections, arranged on silanized slides. The antibodies used were: polyclonal anti-Caspase3 , monoclonal anti-Cleaved Caspase 3 ; monoclonal anti-CD68, monoclonal anti-hormone-sensitive lipase - HSL - and Adipophilin. After preparing the slides, they were analyzed with a DMR microscope (Leica), and photographs were taken at 400x magnification. To quantify the analyses, the ImageJ® software (NIH, Bethesda, USA) was used. All reactions were performed following the manufacturers' protocol and all were standardized by the pathological analysis laboratory of the Hospital de Clínicas da Unicamp. The quantification of immunostaining was performed considering the number of positive cells and intensity, with final scores ranging from

Secondary Outcome Measures

Full Information

First Posted
August 12, 2021
Last Updated
August 18, 2021
Sponsor
Indústria Brasileira Equipamentos Médicos - IBRAMED
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1. Study Identification

Unique Protocol Identification Number
NCT05020054
Brief Title
Effect of Tecartherapy in the Treatment of Localized Fat and Sagging Abdominal Skin - Clinical and Experimental Study
Acronym
Tecarterapy
Official Title
Effect of Tecartherapy in the Treatment of Localized Fat and Sagging Abdominal Skin - Clinical and Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 8, 2019 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indústria Brasileira Equipamentos Médicos - IBRAMED

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
The search for efficient aesthetic treatments has been growing in a large part of the female public, among them the most common are body remodeling with a reduction in localized fat and improvement in the appearance of the skin when the individual has some degree of skin flaccidity. Such unsightly conditions are characterized by intrinsic and extrinsic changes in the individual, with localized fat being associated with a disturbance between consumption, expenditure and supply of related nutrients, poor diet, sedentary lifestyle where triglycerides will be stored in excess in pre-dominant areas, and skin flaccidity characterized by the reduction of fibroblasts, compromising the activity of collagen and elastin proteins responsible for support and elasticity, which may be related to external factors such as pregnancy, weight loss, among others. For the treatment of these aesthetic affections, different treatment options emerged, both invasive and non-invasive. Among the treatment options commonly used in dermatofunctional physiotherapy that can contribute to body remodeling and improvement in the appearance of the skin are ultrasound, carboxytherapy, shockwave therapy and radiofrequency, among others. Within the radiofrequency range is Tecartherapy, High Frequency Capacitive and Resistive Electrical Transfer Therapy which, however, is already known scientifically with good clinical and scientific results in orthopedic physiotherapy for the rehabilitation of muscle injuries. However, some researchers have proposed that the physiological effects of Tecartherapy may favor the treatment of various unsightly conditions, especially wrinkles and skin sagging, as well as the treatment of cellulite and localized fat. According to authors, the heat generated by Tecartherapy acts on the fat cell and the extracellular matrix, in order to produce reversible and irreversible damage to the cells. This situation can lead to changes in the stability of the phospholipid membrane, which are usually followed by cell breakdown and lysis, lipolysis. In the skin, Tecartherapy can favor the stimulation of the dermis by radiofrequency and induce an immediate retraction of collagen fibers and promote the activation of fibroblasts by a mild thermally mediated lesion that induces the synthesis of new collagen fibers (neocollagenesis) and elastic fibers ( neoelastogenesis). Thus, given the possible physiological effects of Tecartherapy and the scarcity of studies on the effectiveness of the technology in the treatment of localized fat and skin sagging, this study is justified with the objective of investigating the effects of the technology, determining its clinical and histological results in these unsightly conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fat Disorder, Fat Redistribution
Keywords
fat disorder, fat redistribution

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
tecarterapia intervention and placebo
Masking
Participant
Masking Description
the participant did not know that the therapy was placebo
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Tecartherapy
Arm Type
Active Comparator
Arm Description
The procedures will be performed with Tecartherapy equipment, with the equipment Nèartek®- IBRAMED- Industria Brasileira de Equipamentos Eletromédicos. The treatment will be carried out once a week, totaling 10 sessions, by two dermato-functional physiotherapists. During the sessions, all volunteers will be positioned in dorsal decubitus and the applicator positioned in the abdominal region, the therapy will be dynamic and simultaneously the professional must assess the local temperature. The parameters used will be: Area of 300cm², 1MHz, Capacitive Mode: 60mm Disc: Default 100W Time of 10 minutes, keeping temperature at 42°C Resistive Mode: 60mm Disc: Default 110W Time of 10 minutes, keeping temperature at 42ºC. The total treatment time is 20 minutes.
Arm Title
Placebo Tecartherapy
Arm Type
Placebo Comparator
Arm Description
the therapy took place with the equipment turned off
Intervention Type
Device
Intervention Name(s)
Tecartherapy Intervention
Other Intervention Name(s)
Intervention
Intervention Description
therapeutic therapy with effective application, connected equipment
Intervention Type
Device
Intervention Name(s)
placebo tecartherapy
Intervention Description
tecartherapy with equipment turned off
Primary Outcome Measure Information:
Title
Immunohistochemical procedures
Description
Immunohistochemical reactions were performed on 3μm-thick sections, arranged on silanized slides. The antibodies used were: polyclonal anti-Caspase3 , monoclonal anti-Cleaved Caspase 3 ; monoclonal anti-CD68, monoclonal anti-hormone-sensitive lipase - HSL - and Adipophilin. After preparing the slides, they were analyzed with a DMR microscope (Leica), and photographs were taken at 400x magnification. To quantify the analyses, the ImageJ® software (NIH, Bethesda, USA) was used. All reactions were performed following the manufacturers' protocol and all were standardized by the pathological analysis laboratory of the Hospital de Clínicas da Unicamp. The quantification of immunostaining was performed considering the number of positive cells and intensity, with final scores ranging from
Time Frame
one month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: participants must be aged between 30 and 45 years of age. body mass index considered normal or overweight 18.5 to 29.9. sedentary. with fat located above 1.5cm and sagging abdominal skin. which cannot be under other aesthetic treatments for the same purpose. must have preserved local understanding and sensitivity. Exclusion Criteria: participants who present alteration in sensitivity. who have contraindications for the use of the therapeutic resource used in the research, which are: Electronic device implanted as a cardiac pacemaker; Large metallic implant in the treated area; Pregnant patients; Patients with venous insufficiency of the lower limbs; About neoplastic areas; Osteoporosis;
Facility Information:
Facility Name
Ibramed - Indústria Brasileira de Equipamentos Médicos
City
Amparo
State/Province
São Paulo
ZIP/Postal Code
13901-080
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Contact the responsible researcher, we can provide the participant data

Learn more about this trial

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

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