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.
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
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.
- Conditions
- Photobiomodulation
- 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 group | Role | What they receive |
|---|---|---|
| Control- Without intervention | No intervention | The participants have the right side of the abdomen as a control without inversion |
| LLLT- With intervention | Active comparator | The 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.
immunohistochemical evaluation
immunohistochemical evaluation with caspase 3 antibody
Measured: one month
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.
- First posted19 Aug 2021
- Study start8 Aug 2020
- Primary completion10 Mar 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotobiomodulationStudies 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
- 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)
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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Led Photobiomodulation Therapy on the Subcutaneous Fatty Tissue of Obese Individuals- Histological and Immunohistochemical Analysis
- ClinicalTrials.gov ID
- NCT05012514
- Acronym / sponsor ID
- LLLT / LLLT
- Conditions
- Photobiomodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Indústria Brasileira Equipamentos Médicos - IBRAMEDIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 19 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control- Without intervention | No intervention | –The participants have the right side of the abdomen as a control without inversion |
| LLLT- With intervention | Active comparator | Device: LLLT REDThe participants received the LED PBMT treatment with associated red and infrared wavelengths sequentially on the left side of the abdomen |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| LLLT REDParticipants 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. | Device | LLLT- With intervention |
Primary outcome
immunohistochemical evaluation
Time frame: one month
immunohistochemical evaluation with caspase 3 antibody
Histological evaluation
Time frame: one month
Histological evaluation with Masson's trichrome dye
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 19 Aug 2021.
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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 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.