RhinoplastyNCT07033039
Effects of Red and Infrared Photobiomodulation in Rhinoplasty at a Single Centre
A study testing Photobiomodulation, Simulation of Photobiomodulation and Standard treatment protocol in people with Rhinoplasty and Edema, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
This single-centre, randomized, double-blind, sham-controlled clinical trial evaluates whether preoperative photobiomodulation (PBM) with red and infrared light can reduce early postoperative periorbital edema in patients undergoing primary open rhinoplasty with osteotomies. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinoplasty, Edema
- What is being tested?
- Photobiomodulation, Simulation of Photobiomodulation and Standard treatment protocol
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jan 2026to 30 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- individuals 18-60 years of age;
- ASA I or II; no comorbidities (no pre-existing diseases);
- indication for rhinoplasty;
- regardless of gender identity.
Who cannot join
- use of anticoagulant,
- anti-inflammatory, or corticosteroid medications;
- indication for closed rhinoplasty;
- procedures not performed using the Piezo device (Schuster SW Surgery II);
- intraoperative complications (e.g., haemorrhage or technical difficulties);
- prior nasal filler with hyaluronic acid;
- use of vitamin A derivatives (oral isotretinoin or topical retinoic acid) within 30 days before surgery;
- or known allergy to any mandatory intra- or postoperative medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Paulista de Otorrinolaringologia
São Paulo, São Paulo, 02404001
Cinthya Duran, 5511981628831, cinthya.gd@hotmail.com
About this study
Official title: Effects of Photobiomodulation With Red and Infrared Low-level Laser Diodes in Individuals Undergoing Rhinoplasty at a Single Centre: Protocol for a Randomized, Double-blind, Controlled Clinical Trial
This single-centre, randomized, double-blind, sham-controlled clinical trial evaluates whether preoperative photobiomodulation (PBM) with red and infrared light can reduce early postoperative periorbital edema in patients undergoing primary open rhinoplasty with osteotomies. Sixty participants will be randomly assigned to receive active PBM or sham PBM one hour before surgery. The primary outcome is periorbital edema on postoperative day 3 measured using a validated ordinal clinical scale with standardized photographic documentation. Secondary outcomes include ecchymosis, postoperative pain, analgesic consumption, nasal tip skin thickness, and patient-reported functional and aesthetic outcomes. Participants will be followed for up to 12 months after surgery.
Read the detailed description
This is a single-centre, randomized, double-blind, sham-controlled clinical trial designed to investigate the effectiveness of preoperative photobiomodulation (PBM) using red (660 nm) and infrared (808 nm) light-emitting diodes in patients undergoing primary open rhinoplasty with piezo-assisted osteotomies. The study hypothesis is that prophylactic PBM applied one hour before surgery can modulate the early inflammatory response and reduce the intensity of postoperative periorbital edema.
Participants will be randomly allocated in a 1:1 ratio to active PBM or sham PBM. Allocation concealment will be ensured using a computer-generated randomization sequence and sealed assignment procedures. Both participants and outcome assessors will be blinded to group allocation. The intervention will be delivered preoperatively by trained personnel following a standardized operating protocol, with predefined anatomical application points and device parameter verification before each session. The sham procedure will follow identical steps, with the device inactive, in order to preserve masking.
All participants will undergo standardized surgical technique and perioperative care according to institutional protocols. Concomitant medications and perioperative management will be recorded to allow assessment of potential confounding effects.
The primary endpoint is assessed early in the postoperative period using a validated ordinal clinical scale applied by a calibrated blinded assessor, with standardized photographic documentation obtained under controlled conditions. Digital image analysis will be used as a complementary objective method to support clinical grading. Additional postoperative clinical and patient-reported measures are collected longitudinally to characterize recovery trajectory and treatment response.
Follow-up visits are scheduled at predefined postoperative time points extending to 12 months. Outcome assessors are trained and calibrated prior to study initiation to ensure inter-rater consistency. Data collection follows standardized case report forms and predefined operational definitions.
Statistical analysis will follow a modified intention-to-treat approach including all randomized participants with at least one postoperative assessment. The primary comparison between groups will use nonparametric methods appropriate for ordinal outcomes. Secondary analyses will be conducted according to data distribution and measurement scale. A two-sided significance level of 0.05 will be adopted. No interim analyses are planned.
Safety monitoring will be conducted throughout the study period, and any adverse events will be documented and reported in accordance with ethical and regulatory requirements.
- Conditions
- Rhinoplasty, Edema
- Being tested
- Photobiomodulation, Simulation of Photobiomodulation, Standard treatment protocol
- Keywords
- Photobiomodulation, Low-Level Laser Therapy, Postoperative, Inflammation
- Medical subject headings
- Edema, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
The photobiomodulation device used in this study will be the ECCO Reability (Ecco Fibras, Campinas, SP, Brazil), which is approved for clinical use by the Brazilian Health Regulatory Agency (ANVISA) under registration number 80323310001. The equipment is also certified by INMETRO, ensuring adherence to nationally established safety and performance standards.
Simulation of PhotobiomodulationOther
In the sham group, the photobiomodulation procedure will be simulated with the device turned off. To preserve blinding, the equipment will be positioned as in the active treatment and its operational sound will be reproduced during the simulation, ensuring that the intervention remains indistinguishable from the actual PBM application.
Standard treatment protocolProcedure or surgery
All participants will undergo primary open rhinoplasty performed using piezo-assisted osteotomies, following standardized surgical protocols. Subperiosteal dissection will be carried out along the lateral nasal walls, with supraperiosteal dissection in the medial region of the bony nasal dorsum. The configuration of osteotomies will be selected according to individual anatomical and surgical requirements. All procedures will be performed by experienced otolaryngologists.
All participants will also receive standardized perioperative medical care, identical in both groups. No medication will be administered preoperatively. Intraoperatively, dexamethasone 4 mg and tranexamic acid 1 g will be administered intravenously. Postoperative in-hospital care will include hydrocortisone 200 mg IV, tranexamic acid 250 mg IV, dipyrone 1 g IV, and cefazolin 1 g IV every 8 hours, with ketorolac 10 mg sublingual as needed. After discharge, patients will receive cefuroxime axetil 500 mg orally every 12
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation Group | Experimental | Participants will receive active photobiomodulation (PBM) one hour before rhinoplasty, in addition to standard surgical and perioperative care. Receives: Device: Photobiomodulation; Procedure: Standard treatment protocol |
| Simulation of Photobiomodulation Group | Sham comparator | Participants will receive a sham photobiomodulation procedure one hour before rhinoplasty, in addition to standard surgical and perioperative care. Receives: Other: Simulation of Photobiomodulation; Procedure: Standard treatment protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periorbital Edema on postoperative day 3
Periorbital edema on postoperative day 3 will be assessed using the Hoffmann Clinical Ordinal Scale for Periorbital Edema (score range 0 to 4), based on the extent of eyelid involvement. In this scale, higher scores indicate more severe edema and therefore a worse outcome. Assessments will be performed by a blinded and calibrated evaluator. Standardized photographic documentation will be obtained and analyzed using ImageJ software as a complementary objective measurement.
Measured: Postoperative day 3
Secondary outcomes (6)
Periorbital Edema Time Course
Periorbital edema assessed using the Hoffmann clinical scale (0-4), based on eyelid involvement, evaluated by a blinded and calibrated assessor, with standardized photographic documentation and complementary ImageJ analysis.
Measured: 7, 30, 60, and 90 days; 6 and 12 months postoperatively
Periorbital Ecchymosis
Periorbital ecchymosis assessed using the Hoffmann clinical ordinal scale (0-4), based on the extent and intensity of periorbital discoloration, evaluated by a trained assessor blinded to group allocation.
Measured: 3, 7, 30, 60, and 90 days; 6 and 12 months postoperatively
Nasal Tip Skin Thickness
Skin thickness will be assessed through physical examination of the nasal tip using a standardized protocol. The evaluations will be conducted by a trained clinician during scheduled follow-up visits.
Measured: Preoperative baseline; 3, 7, 30, 60, and 90 days; 6 and 12 months postoperatively
Postoperative Pain (VAS)
Postoperative pain will be assessed using the Visual Analog Scale (VAS), a validated tool commonly used in rhinoplasty research. A 10 cm horizontal ruler will be used, with endpoints labeled "0" (no pain) and "10" (worst imaginable pain),. All participants will use the same standardized ruler.
Measured: 3 and 7 days postoperatively
Patient-Reported Functional and Aesthetic Outcomes (SCHNOS)
Functional and aesthetic outcomes assessed using the Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS), validated for Brazilian Portuguese.
Measured: Preoperative baseline; 30 and 90 days; 6 and 12 months postoperatively
Analgesic Consumption
Total amount of analgesic medication ingested by each participant, recorded as an indirect indicator of postoperative pain control and functional recovery.
Measured: 3, 7, 30, 60, and 90 days; 6 and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start30 Jan 2026
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2030 (estimated)
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 RhinoplastyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled, single centre, double-blind clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cinthya Cosme Gutierrez Duran, University of Nove de Julho
- Investigators
- Cinthya CG Duran, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033039
- Sponsor's protocol ID
- 7.503.097
- Status last verified
- Mar 2026
- First submitted
- 13 Jun 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analysed during the current study are available from the corresponding author upon reasonable request.
Publications
Azevedo MA, Dolci ELL, Maciel MLFL, Coelho MS, Kitamura RH, Quedas A, Bussadori SK, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Duran CCG. Effects of photobiomodulation with red and infrared low-level laser diodes in individuals undergoing rhinoplasty at a single centre in Sao Paulo, Brazil: protocol for a randomised, double-blind, controlled clinical trial. BMJ Open. 2026 Apr 27;16(4):e112848. doi: 10.1136/bmjopen-2025-112848.
PubMed 42044952
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation With Red and Infrared Low-level Laser Diodes in Individuals Undergoing Rhinoplasty at a Single Centre: Protocol for a Randomized, Double-blind, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07033039
- Acronym / sponsor ID
- 7.503.097
- Conditions
- Rhinoplasty, Edema
- Keywords
- Photobiomodulation, Low-Level Laser Therapy, Postoperative, Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 24 Jun 2025 (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.
This single-centre, randomized, double-blind, sham-controlled clinical trial evaluates whether preoperative photobiomodulation (PBM) with red and infrared light can reduce early postoperative periorbital edema in patients undergoing primary open rhinoplasty with osteotomies. Sixty participants will be randomly assigned to receive active PBM or sham PBM one hour before surgery. The primary outcome is periorbital edema on postoperative day 3 measured using a validated ordinal clinical scale with standardized photographic documentation. Secondary outcomes include ecchymosis, postoperative pain, analgesic consumption, nasal tip skin thickness, and patient-reported functional and aesthetic outcomes. Participants will be followed for up to 12 months after surgery.
Detailed description
This is a single-centre, randomized, double-blind, sham-controlled clinical trial designed to investigate the effectiveness of preoperative photobiomodulation (PBM) using red (660 nm) and infrared (808 nm) light-emitting diodes in patients undergoing primary open rhinoplasty with piezo-assisted osteotomies. The study hypothesis is that prophylactic PBM applied one hour before surgery can modulate the early inflammatory response and reduce the intensity of postoperative periorbital edema.
Participants will be randomly allocated in a 1:1 ratio to active PBM or sham PBM. Allocation concealment will be ensured using a computer-generated randomization sequence and sealed assignment procedures. Both participants and outcome assessors will be blinded to group allocation. The intervention will be delivered preoperatively by trained personnel following a standardized operating protocol, with predefined anatomical application points and device parameter verification before each session. The sham procedure will follow identical steps, with the device inactive, in order to preserve masking.
All participants will undergo standardized surgical technique and perioperative care according to institutional protocols. Concomitant medications and perioperative management will be recorded to allow assessment of potential confounding effects.
The primary endpoint is assessed early in the postoperative period using a validated ordinal clinical scale applied by a calibrated blinded assessor, with standardized photographic documentation obtained under controlled conditions. Digital image analysis will be used as a complementary objective method to support clinical grading. Additional postoperative clinical and patient-reported measures are collected longitudinally to characterize recovery trajectory and treatment response.
Follow-up visits are scheduled at predefined postoperative time points extending to 12 months. Outcome assessors are trained and calibrated prior to study initiation to ensure inter-rater consistency. Data collection follows standardized case report forms and predefined operational definitions.
Statistical analysis will follow a modified intention-to-treat approach including all randomized participants with at least one postoperative assessment. The primary comparison between groups will use nonparametric methods appropriate for ordinal outcomes. Secondary analyses will be conducted according to data distribution and measurement scale. A two-sided significance level of 0.05 will be adopted. No interim analyses are planned.
Safety monitoring will be conducted throughout the study period, and any adverse events will be documented and reported in accordance with ethical and regulatory requirements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, controlled, single centre, double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation Group | Experimental | Device: Photobiomodulation, Procedure: Standard treatment protocolParticipants will receive active photobiomodulation (PBM) one hour before rhinoplasty, in addition to standard surgical and perioperative care. |
| Simulation of Photobiomodulation Group | Sham comparator | Other: Simulation of Photobiomodulation, Procedure: Standard treatment protocolParticipants will receive a sham photobiomodulation procedure one hour before rhinoplasty, in addition to standard surgical and perioperative care. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- individuals 18-60 years of age;
- ASA I or II; no comorbidities (no pre-existing diseases);
- indication for rhinoplasty;
- regardless of gender identity.
Key exclusion criteria (8 listed)
- use of anticoagulant,
- anti-inflammatory, or corticosteroid medications;
- indication for closed rhinoplasty;
- procedures not performed using the Piezo device (Schuster SW Surgery II);
- intraoperative complications (e.g., haemorrhage or technical difficulties);
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 |
|---|---|---|
| PhotobiomodulationThe photobiomodulation device used in this study will be the ECCO Reability (Ecco Fibras, Campinas, SP, Brazil), which is approved for clinical use by the Brazilian Health Regulatory Agency (ANVISA) under registration number 80323310001. The equipment is also certified by INMETRO, ensuring adherence to nationally established safety and performance standards. | Device | Photobiomodulation Group |
| Simulation of PhotobiomodulationIn the sham group, the photobiomodulation procedure will be simulated with the device turned off. To preserve blinding, the equipment will be positioned as in the active treatment and its operational sound will be reproduced during the simulation, ensuring that the intervention remains indistinguishable from the actual PBM application. | Other | Simulation of Photobiomodulation Group |
| Standard treatment protocolAll participants will undergo primary open rhinoplasty performed using piezo-assisted osteotomies, following standardized surgical protocols. Subperiosteal dissection will be carried out along the lateral nasal walls, with supraperiosteal dissection in the medial region of the bony nasal dorsum. The configuration of osteotomies will be selected according to individual anatomical and surgical requirements. All procedures will be performed by experienced otolaryngologists. All participants will also receive standardized perioperative medical care, identical in both groups. No medication will be administered preoperatively. Intraoperatively, dexamethasone 4 mg and tranexamic acid 1 g will be administered intravenously. Postoperative in-hospital care will include hydrocortisone 200 mg IV, tranexamic acid 250 mg IV, dipyrone 1 g IV, and cefazolin 1 g IV every 8 hours, with ketorolac 10 mg sublingual as needed. After discharge, patients will receive cefuroxime axetil 500 mg orally every 12 | Procedure or surgery | Photobiomodulation Group, Simulation of Photobiomodulation Group |
Primary outcome
Periorbital Edema on postoperative day 3
Time frame: Postoperative day 3
Periorbital edema on postoperative day 3 will be assessed using the Hoffmann Clinical Ordinal Scale for Periorbital Edema (score range 0 to 4), based on the extent of eyelid involvement. In this scale, higher scores indicate more severe edema and therefore a worse outcome. Assessments will be performed by a blinded and calibrated evaluator. Standardized photographic documentation will be obtained and analyzed using ImageJ software as a complementary objective measurement.
6 secondary outcomes
Periorbital Edema Time Course
Time frame: 7, 30, 60, and 90 days; 6 and 12 months postoperatively
Periorbital Ecchymosis
Time frame: 3, 7, 30, 60, and 90 days; 6 and 12 months postoperatively
Nasal Tip Skin Thickness
Time frame: Preoperative baseline; 3, 7, 30, 60, and 90 days; 6 and 12 months postoperatively
Postoperative Pain (VAS)
Time frame: 3 and 7 days postoperatively
Patient-Reported Functional and Aesthetic Outcomes (SCHNOS)
Time frame: Preoperative baseline; 30 and 90 days; 6 and 12 months postoperatively
Analgesic Consumption
Time frame: 3, 7, 30, 60, and 90 days; 6 and 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Derived from this study: PubMed 42044952Azevedo MA, Dolci ELL, Maciel MLFL, Coelho MS, Kitamura RH, Quedas A, Bussadori SK, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Duran CCG. Effects of photobiomodulation with red and infrared low-level laser diodes in individuals undergoing rhinoplasty at a single centre in Sao Paulo, Brazil: protocol for a randomised, double-blind, controlled clinical trial. BMJ Open. 2026 Apr 27;16(4):e112848. doi: 10.1136/bmjopen-2025-112848.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analysed during the current study are available from the corresponding author upon reasonable request.
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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.
Cinthya CG Duran, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation, Simulation of Photobiomodulation and Standard treatment protocol in people with Rhinoplasty and Edema, run by University of Nove de Julho 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 4 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: looking for participants now, as of the sponsor's last update on 24 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cinthya CG Duran, PhD (5511981628831, cinthya.cgduran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periorbital Edema on postoperative day 3 (time frame: Postoperative day 3). 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 NCT07033039, 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 24 Mar 2026.