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

NCT05020054 | Completed DMC

• 1 other identifier: Tecarterapy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fat Disorder; Fat Redistribution

Keywords

fat disorder; fat redistribution

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention Tecartherapy

ACTIVE COMPARATOR

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.

Device: Tecartherapy Intervention

Placebo Tecartherapy

PLACEBO COMPARATOR

the therapy took place with the equipment turned off

Device: placebo tecartherapy

Interventions

Tecartherapy Intervention DEVICE

therapeutic therapy with effective application, connected equipment

Also known as: Intervention

Intervention Tecartherapy

placebo tecartherapy DEVICE

tecartherapy with equipment turned off

Placebo Tecartherapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Indústria Brasileira Equipamentos Médicos - IBRAMED: lead

Study Sites (1)

Ibramed - Indústria Brasileira de Equipamentos Médicos

Amparo, São Paulo, 13901-080, Brazil

Location

MeSH Terms

Conditions

Lipid Metabolism Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the participant did not know that the therapy was placebo
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: tecarterapia intervention and placebo

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 25, 2021
• Study Start: February 8, 2019
• Primary Completion: February 10, 2020
• Study Completion: July 1, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)