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PhotobiomodulationLLLTNCT05012514

Effects of Led Photobiomodulation Therapy

A study testing LLLT RED in people with Photobiomodulation, run by Indústria Brasileira Equipamentos Médicos - IBRAMED at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Photobiomodulation therapy (PBMT) has become an adjuvant therapeutic possibility in body remodeling procedures. Although this modality emerged in 1960, there are still few studies that demonstrate the real mechanism of action and possible interaction with subcutaneous fatty tissue. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Photobiomodulation
What is being tested?
LLLT RED
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteBrazil
Study dates
8 Aug 2020to 1 Aug 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 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • As inclusion criteria, women participating in the group of pre-surgical preparation for bariatric surgery at the Hospital de Clínicas da Unicamp [Unicamp Clinics Hospital], presenting obesity degrees II and III, who had weight loss of at least 10% of the initial weight with indication for bariatric surgery.

Who cannot join

  • As exclusion criteria, women presenting diabetes mellitus, with skin lesions such as dermatitis and dermatosis, with a history of deep venous thrombosis, smokers, or who had electronic implanted devices such as cardiac pacemakers were ineligible.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Ibramed - Indústria Brasileira de Equipamentos Médicos

    Amparo, São Paulo, 13901-080

Other trials in Brazil

About this study

Official title: Effects of Led Photobiomodulation Therapy on the Subcutaneous Fatty Tissue of Obese Individuals- Histological and Immunohistochemical Analysis

Background: Photobiomodulation therapy (PBMT) has become an adjuvant therapeutic possibility in body remodeling procedures. Although this modality emerged in 1960, there are still few studies that demonstrate the real mechanism of action and possible interaction with subcutaneous fatty tissue. Given this scenario, this study was proposed with the aim of evaluating the effects of PBMT to Light Emitting Diode (LED) associating the red (630 nm) and infrared (850 nm) wavelengths in the subcutaneous fatty tissue. Methods: This is a non-randomized controlled study of comparative intervention that evaluated a sample of subcutaneous fatty tissue from women with grade II obesity. The participants received the LED PBMT treatment with associated red and infrared wavelengths sequentially on the left side of the abdomen and the right side was considered as control, with the collection of biological material performed at the time of bariatric surgery. For histological and immunohistochemical evaluation, Caspase 3, Cleaved Caspase 3, CD68+, HSL and adipophilin markers were used.

Read the detailed description

Localized adiposity or localized obesity is the hyperplasia or hypertrophy of adipocytes in specific areas such as the abdomen and flanks, its development is associated with the risk of metabolic diseases and psychosocial changes related to low self-esteem, since aesthetic appearance is considered an imposed standard of beauty nowadays.

The proportion of obese individuals has increased at alarming levels around the world and to combat it, several therapeutic approaches are needed, such as personalized diets and physical activity plans, in order to balance consumption and energy expenditure, but despite these controls, several adjuvant features such as non-invasive modalities are also being proposed to reduce subcutaneous fatty tissue.

Among these modalities are the technologies of shock waves, cryolipolysis, focused ultrasound, radiofrequency and the use of light sources with photobiomodulation therapy. The latter, in turn, has shown relevant results in the possible reduction of subcutaneous fatty tissue.

The use of a light source as a therapeutic form is already millenary and nowadays it is widely used as a modality to promote wound healing, reduce pain and possible damage and inflammation of tissues with the characteristic of not presenting photothermal or photoacoustic effects, thus termed as photobiomodulation therapy (PBMT). It can be used by using non-ionizing light sources such as Low Intensity Laser Therapy (LLLT) or Light Emitting Diode Therapy (LED).

The landmark of the use of PBMT in the possible reduction of subcutaneous fatty tissue emerged with the double-blind randomized placebo-controlled study by Jackson et al. in 2012. A total of 689 individuals participated in the study, subdivided into a placebo group and an LLLT group, all of whom were evaluated during the treatment, in order to verify the possible reduction in the circumference of the waist, hips and thighs. Participants received a total of six LLLT treatments over 2 weeks with baseline and post-procedure circumferential measurements recorded. The results showed a significant reduction (p<0.0001) in circumference at the waist, hips and thighs one week after treatment with LLLT.

Following the same line of research Jankowski et al., and Elnaggar, also carried out photobiomodulation studies to reduce fatty tissue and show partially significant results. The justification for the result was the smaller sample of participants compared to the study by Jackson et al., , however these studies were not able to elucidate which form of therapeutic action on fatty tissue to promote its reduction.

The mechanisms by which PBMT can affect fatty tissue are still controversial, and it is hypothesized that PBMT could induce micropores in the adipocyte membrane, which allow the release of intracellular lipids and place them outside the interstitial space or an alternative hypothesis is that PBMT stimulates mitochondria in adipocytes, which, in turn, increases adenosine triphosphate (ATP) synthesis with subsequent activation of cyclic adenosine monophosphate (cAMP), promoting lipolysis, and the third hypothesis is that it depends on of the dose applied in PBMT, this can even stimulate adipocyte cell apoptosis, that is, there is still no clear physiological basis for its mechanism.

Another important PBMT fact for the reduction of fatty tissue observed in articles already published is the difference in the wavelengths used, and in some articles the photobiomodulation was carried out with the red wavelength 630nm and in others the infrared 808 or 850nm. It is believed that each of them must reach different depths of the fatty tissue and thus favor its reduction, however, there is no standardization of the protocol.

Given this scenario, this study aimed to verify the real mechanism of action of PBMT when used in association of the wavelengths, red (630nm) and infrared (850nm) in the subcutaneous fatty tissue, through a clinical study with histological and immunohistochemistry analysis with markers of lipolysis and apoptosis in the subcutaneous fatty tissue of obese individuals.

Being tested
LLLT RED

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LLLT REDDevice

    Participants received seven sessions of PBMT LED twice a week, the last session being about twenty minutes before the surgical procedure of bariatric surgery. The therapy was performed on the left side of the abdominal region following the linea alba of all research participants and the right side was considered as control, for application they will receive eye protection, using goggles for safety, the abdomen of the participants will be cleaned by using a neutral cleansing soap. A cluster applicator was used using the parameters described in table 1.

    For therapy, the equipment Antares® was used, IBRAMED- Indústria Brasileira de Equipamentos Eletromédicos EIRELI [EIRELI Brazilian Industry of Electromedical Equipment], approved by Anvisa Nº 10360310037. Figure 1.

Study groups in NCT05012514
Study groupRoleWhat they receive
Control- Without interventionNo interventionThe participants have the right side of the abdomen as a control without inversion
LLLT- With interventionActive comparatorThe participants received the LED PBMT treatment with associated red and infrared wavelengths sequentially on the left side of the abdomen
Receives: Device: LLLT RED

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. immunohistochemical evaluation

    immunohistochemical evaluation with caspase 3 antibody

    Measured: one month

  2. Histological evaluation

    Histological evaluation with Masson's trichrome dye

    Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2021
  2. Study start8 Aug 2020
  3. Primary completion10 Mar 2021
  4. Study completion1 Aug 2021

Resources

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
Non-randomised
Intervention model
Single group
Model description
Participants received seven sessions of PBMT LED twice a week, the last session being about twenty minutes before the surgical procedure of bariatric surgery. The therapy was performed on the left side of the abdominal region following the linea alba of all research participants and the right side was considered as control, for application they will receive eye protection, using goggles for safety, the abdomen of the participants will be cleaned by using a neutral cleansing soap.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05012514
Sponsor's protocol ID
LLLT
Acronym
LLLT
Status last verified
Aug 2021
First submitted
3 Aug 2021
Last updated
19 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing LLLT RED in people with Photobiomodulation, 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 1 inclusion and 1 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 19 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. 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 evaluation (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 Aug 2021.

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