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

Fat Disorder Clinical Trial

— Tecarterapy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05020054
• Other study ID #: Tecarterapy
• Status: Completed
• Phase: N/A
• Start date: February 8, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: August 2021
• Source: Indústria Brasileira Equipamentos Médicos - IBRAMED
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 1, 2021
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Fat Disorder
• Lipid Metabolism Disorders

Intervention

Device:
• Tecartherapy Intervention
therapeutic therapy with effective application, connected equipment
• placebo tecartherapy
tecartherapy with equipment turned off

Locations

Country	Name	City	State
Brazil	Ibramed - Indústria Brasileira de Equipamentos Médicos	Amparo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Indústria Brasileira Equipamentos Médicos - IBRAMED

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one month