Fat DisorderTecarterapyNCT05020054
Effect of Tecartherapy in the Treatment of Localized Fat and Sagging Abdominal Skin - Clinical and Experimental Study
A study testing Tecartherapy Intervention in people with Fat Disorder and Fat Redistribution, run by Indústria Brasileira Equipamentos Médicos - IBRAMED at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fat Disorder, Fat Redistribution
- What is being tested?
- Tecartherapy Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Feb 2019to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ibramed - Indústria Brasileira de Equipamentos Médicos
Amparo, São Paulo, 13901-080
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Fat Disorder, Fat Redistribution
- Being tested
- Tecartherapy Intervention, placebo tecartherapy
- Keywords
- fat disorder, fat redistribution
- Medical subject headings
- Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecartherapy InterventionDevice
Also called Intervention
therapeutic therapy with effective application, connected equipment
placebo tecartherapyDevice
tecartherapy with equipment turned off
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Tecartherapy Intervention |
| Placebo Tecartherapy | Placebo comparator | the therapy took place with the equipment turned off Receives: Device: placebo tecartherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start8 Feb 2019
- Primary completion10 Feb 2020
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fat DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- tecarterapia intervention and placebo
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indústria Brasileira Equipamentos Médicos - IBRAMED
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020054
- Sponsor's protocol ID
- Tecarterapy
- Acronym
- Tecarterapy
- Status last verified
- Aug 2021
- First submitted
- 12 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Contact the responsible researcher, we can provide the participant data
Publications
de Almeida S, Santiago IB, Santi Martignago CC, Nishioka MA, Brassolatti P, Franco Dorigatti JH, Chieregato F, Araruna Alves AC, Queiroga Farias SL, Meyer PF, Ricardo de Souza J. Effect of Tecar Therapy in the Treatment of Skin Flaccidity and Localized Abdominal Fat-Clinical and Controlled Study. Dermatol Res Pract. 2026 Feb 23;2026:5531539. doi: 10.1155/drp/5531539. eCollection 2026.
PubMed 41737345
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tecartherapy in the Treatment of Localized Fat and Sagging Abdominal Skin - Clinical and Experimental Study
- ClinicalTrials.gov ID
- NCT05020054
- Acronym / sponsor ID
- Tecarterapy / Tecarterapy
- Conditions
- Fat Disorder, Fat Redistribution
- Keywords
- fat disorder, fat redistribution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Indústria Brasileira Equipamentos Médicos - IBRAMEDIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- tecarterapia intervention and placebo
| Arm | Type | Receives |
|---|---|---|
| Intervention Tecartherapy | Active comparator | Device: Tecartherapy InterventionThe 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. |
| Placebo Tecartherapy | Placebo comparator | Device: placebo tecartherapythe therapy took place with the equipment turned off |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tecartherapy InterventionAlso: Interventiontherapeutic therapy with effective application, connected equipment | Device | Intervention Tecartherapy |
| placebo tecartherapytecartherapy with equipment turned off | Device | Placebo Tecartherapy |
Primary outcome
Immunohistochemical procedures
Time frame: one month
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 41737345de Almeida S, Santiago IB, Santi Martignago CC, Nishioka MA, Brassolatti P, Franco Dorigatti JH, Chieregato F, Araruna Alves AC, Queiroga Farias SL, Meyer PF, Ricardo de Souza J. Effect of Tecar Therapy in the Treatment of Skin Flaccidity and Localized Abdominal Fat-Clinical and Controlled Study. Dermatol Res Pract. 2026 Feb 23;2026:5531539. doi: 10.1155/drp/5531539. eCollection 2026.
- Individual participant dataSharing planned: No. Contact the responsible researcher, we can provide the participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tecartherapy Intervention in people with Fat Disorder and Fat Redistribution, run by Indústria Brasileira Equipamentos Médicos - IBRAMED at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunohistochemical procedures (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05020054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.