Postoperative Facial EcchymosisCLEAR PBMNCT07846631
Perioperative Photobiomodulation in Facial Plastic Surgery
A study testing ELIXIR MD Photobiomodulation (PBM) System in people with Postoperative Facial Ecchymosis and Postoperative Facial Edema, run by Elixir MD Inc at 1 site in United States.
Trial summary
This study is testing whether a new light therapy schedule can reduce bruising after facial plastic surgery, compared with the light therapy schedule currently used in the investigator's practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Facial Ecchymosis, Postoperative Facial Edema
- What is being tested?
- ELIXIR MD Photobiomodulation (PBM) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2026to 20 Jul 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Scheduled for elective facial plastic surgery at the study site: rhinoplasty, facelift and/or neck lift, blepharoplasty, brow lift, or a combination of these procedures.
- Able and willing to attend the perioperative visits and standardized photography required by the protocol.
- Able to read, understand, and provide written informed consent in English.
Who cannot join
- Known photosensitivity disorder, or current use of a photosensitizing medication (for example, systemic isotretinoin, tetracyclines, amiodarone, methoxsalen, or systemic photodynamic agents), though this may be up to treating physician discretion.
- Active facial infection or dermatitis at a treatment site.
- History of keloid formation, or an uncontrolled pigmentary disorder (for example, active melasma or post-inflammatory hyperpigmentation under treatment).
- Pregnancy or breastfeeding.
- Therapeutic anticoagulation (for example, warfarin or a direct oral anticoagulant) or high-dose aspirin or nonsteroidal anti-inflammatory drug (NSAID) use that has not been discontinued preoperatively per the site's standard perioperative protocol.
- Inability to provide independent informed consent, or reliance on a legally authorized representative. Adults who lack decisional capacity are not enrolled.
- Concurrent enrollment in another interventional clinical study affecting facial healing or inflammation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dallas Plastic Surgery Institute
Dallas, Texas, 75231
Rod J Rohrich, MD, FACS, 214-821-9114, rod.rohrich@dpsi.org
About this study
Official title: Perioperative Photobiomodulation With the ELIXIR MD System in Facial Plastic Surgery: A Randomized Controlled Trial
This study is testing whether a new light therapy schedule can reduce bruising after facial plastic surgery, compared with the light therapy schedule currently used in the investigator's practice.
Participants having elective facial plastic surgery (such as rhinoplasty, facelift and/or neck lift, blepharoplasty, or brow lift) at the study site may take part. All participants receive photobiomodulation (PBM), a non-contact light therapy already used in the practice as part of routine perioperative care. The study device, the ELIXIR MD system, delivers blue, yellow, red, and near-infrared light and is legally marketed in the United States under a U.S. Food and Drug Administration (FDA) 510(k) clearance, though its use in this study to evaluate reduction of postoperative bruising and swelling is not among its currently cleared uses.
Read more
Participants are randomly assigned (1:1) to one of two light therapy schedules: the schedule currently used in the practice, or a new multi-wavelength schedule being studied. Researchers do not know in advance which schedule reduces bruising more; that is the main question this study is designed to answer. The study is not placebo-controlled, because photobiomodulation is already part of routine care at the site; there is no untreated comparison group.
The main measurement is how visible facial bruising is about 7 days after surgery, based on standardized photographs graded by an assessor who does not know which treatment the participant received. The study also looks at facial swelling, pain, patient-reported recovery, and safety (including skin reactions and wound healing).
This is a small pilot study of about 40 participants at a single study site. It is designed to give an early estimate of whether the new schedule helps and to inform a future, larger study. It is not designed or statistically powered to prove that either schedule works.
- Being tested
- ELIXIR MD Photobiomodulation (PBM) System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELIXIR MD Photobiomodulation (PBM) SystemDevice
Non-contact, continuous-wave light-emitting diode (LED) photobiomodulation (PBM) device delivering blue (417 nanometers [nm]), yellow (590 nm), red (633 nm), and near-infrared (835 nm) light; U.S. Food and Drug Administration (FDA) 510(k) K241293, product code GEX. Delivered at a working distance of 80-120 millimeters (mm) in 20-minute (1,200 second) sessions. In this study, delivered per the Arm A schedule: blue 417 nm preoperatively; yellow 590 nm at each postoperative session through postoperative day (POD) 7; red + yellow at POD 10 (Cohort 1); a reduced schedule applies to Cohort 2. This is the regimen currently used in the investigator's practice, unchanged by study participation.
ELIXIR MD Photobiomodulation (PBM) SystemDevice
Non-contact, continuous-wave light-emitting diode (LED) photobiomodulation (PBM) device delivering blue (417 nanometers [nm]), yellow (590 nm), red (633 nm), and near-infrared (835 nm) light; U.S. Food and Drug Administration (FDA) 510(k) K241293, product code GEX. Delivered at a working distance of 80-120 millimeters (mm) in 20-minute (1,200 second) sessions. In this study, delivered per the Arm B schedule: blue 417 nm preoperatively (identical to Arm A); near-infrared + yellow from the immediate postoperative session through postoperative day (POD) 2; near-infrared + red at POD 7 and POD 10. This is the sponsor's proposed regimen; its benefit and risk profile are less well characterized than Arm A's.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Current-Practice Photobiomodulation (PBM) Regimen | Active comparator | Perioperative photobiomodulation (PBM) via the ELIXIR MD system, using the regimen currently used in the investigator's practice. Blue 417 nanometers (nm) at 50 milliwatts per square centimeter (mW/cm2) preoperatively; yellow 590 nm (19.1 mW/cm2) at each postoperative session through postoperative day (POD) 7; red 633 nm + yellow 590 nm (64.1 mW/cm2 combined) at POD 10 (Cohort 1 schedule). Cohort 2 (isolated rhinoplasty/blepharoplasty) receives a reduced schedule per the protocol. Each session is 20 minutes, non-contact, at a working distance of 80-120 millimeters (mm). Receives: Device: ELIXIR MD Photobiomodulation (PBM) System |
| Arm B: Investigational Multi-Wavelength Photobiomodulation (PBM) Regimen | Experimental | Perioperative photobiomodulation (PBM) via the ELIXIR MD system, using the sponsor's proposed multi-wavelength regimen. Blue 417 nanometers (nm) at 50 milliwatts per square centimeter (mW/cm2) preoperatively (identical to Arm A); near-infrared 835 nm + yellow 590 nm (29.1 mW/cm2 combined) from the immediate postoperative session through postoperative day (POD) 2; near-infrared 835 nm + red 633 nm (55 mW/cm2 combined) at POD 7 and POD 10. Each session is 20 minutes, non-contact, at a working distance of 80-120 millimeters (mm). This regimen's benefit and risk profile are less well characterized than Arm A's. Receives: Device: ELIXIR MD Photobiomodulation (PBM) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Facial Bruising (Bruise Visibility Scale)
Graded from standardized photographs (frontal and bilateral oblique views) using the Bruise Visibility Scale (BVS; Scafide et al., 2021), a 1-5 visual analogue scale developed and validated for in-person assessment of accidental bruises on the arms and legs. In this study the BVS is applied to standardized postoperative facial photographs, a context (face rather than limb, photograph rather than in-person, surgical rather than blunt-trauma etiology) in which it has not been formally validated; no claim of validation for this application is made. Grading is performed by a blinded assessor after all Postoperative Day 7 visits are complete.
Measured: Postoperative Day 7 (±2 days)
Secondary outcomes (11)
Postoperative Facial Swelling (Investigator-Adapted Ordinal Scale)
Graded from the same Postoperative Day 7 photographs using a five-point, anchored, investigator-adapted ordinal scale: 0 = no swelling to 4 = severe (marked edema substantially altering facial appearance).
Measured: Postoperative Day 7 (±2 days)
Postoperative Pain Intensity (Numeric Rating Scale)
Participant-rated facial pain or discomfort on a 0-10 numeric rating scale (NRS), collected as Item 1 of the ELIXIR MD Brief Recovery Instrument, where 0 = no pain at all and 10 = worst pain imaginable; higher scores indicate worse pain. Reported by arm as the score at each assessment visit. Postoperative Days 1, 2, and 10 are assessed in Cohort 1 (facelift, neck lift, brow lift, and combined procedures) only; Postoperative Day 10 data are supportive and exploratory. Unit of measure: score on a scale (0-10).
Measured: Baseline (preoperative), Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only)
Number of Participants With Analgesic Use at Each Visit
Analgesic use (yes/no) recorded on the case report form (CRF) at each assessment visit. Reported by arm as the number of participants with analgesic use at each visit. Postoperative Days 1, 2, and 10 are assessed in Cohort 1 (facelift, neck lift, brow lift, and combined procedures) only; Postoperative Day 10 data are supportive and exploratory. Unit of measure: participants.
Measured: Baseline (preoperative), Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only)
Change From Baseline in Patient-Reported Swelling Score (ELIXIR MD Brief Recovery Instrument, Item 2)
Self-perceived facial swelling rated by the participant on Item 2 of the ELIXIR MD Brief Recovery Instrument, a five-item, study-specific, investigator-designed questionnaire completed by the participant in clinic. The instrument has not undergone formal psychometric validation; items are analyzed individually and no composite score is computed. Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe; higher scores indicate more swelling. Reported by arm as change from baseline at each postoperative visit. Postoperative Days 1, 2, and 10 are assessed in Cohort 1 (facelift, neck lift, brow lift, and combined procedures) only; Postoperative Day 10 data are supportive and exploratory. Unit of measure: score on a scale (0-3).
Measured: Baseline (preoperative) to Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only)
Number of Participants With Adverse Events
Number of participants in each arm with one or more adverse events (AEs), assessed clinically by the Principal Investigator. No hypothesis test of safety is prespecified; the study is not powered for safety comparison. Unit of measure: participants.
Measured: From consent through final study visit (Postoperative Day 7, or Postoperative Day 10 for Cohort 1 if attended)
Number of Participants With Treatment-Area Erythema
Number of participants in each arm with erythema (skin redness) at a treatment site, assessed clinically by the Principal Investigator. No hypothesis test is prespecified. Unit of measure: participants.
Measured: From consent through final study visit (Postoperative Day 7, or Postoperative Day 10 for Cohort 1 if attended)
Number of Participants With Treatment-Area Pigmentary Change
Number of participants in each arm with new pigmentary change (hyperpigmentation or hypopigmentation) at a treatment site, assessed clinically by the Principal Investigator. No hypothesis test is prespecified. Unit of measure: participants.
Measured: From consent through final study visit (Postoperative Day 7, or Postoperative Day 10 for Cohort 1 if attended)
Number of Participants With Wound Complications
Number of participants in each arm with one or more wound complications, assessed clinically by the Principal Investigator. No hypothesis test is prespecified. Unit of measure: participants.
Measured: From consent through final study visit (Postoperative Day 7, or Postoperative Day 10 for Cohort 1 if attended)
Change From Baseline in Patient-Reported Bruising Score (ELIXIR MD Brief Recovery Instrument, Item 3)
Self-perceived facial bruising rated by the participant on Item 3 of the ELIXIR MD Brief Recovery Instrument, a five-item, study-specific, investigator-designed questionnaire completed by the participant in clinic. The instrument has not undergone formal psychometric validation; items are analyzed individually and no composite score is computed. Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe; higher scores indicate more bruising. Reported by arm as change from baseline at each postoperative visit. Postoperative Days 1, 2, and 10 are assessed in Cohort 1 (facelift, neck lift, brow lift, and combined procedures) only; Postoperative Day 10 data are supportive and exploratory. Unit of measure: score on a scale (0-3).
Measured: Baseline (preoperative) to Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only)
Change From Baseline in Patient-Reported Overall Recovery Score (ELIXIR MD Brief Recovery Instrument, Item 4)
Overall recovery rated by the participant on Item 4 of the ELIXIR MD Brief Recovery Instrument, a five-item, study-specific, investigator-designed questionnaire completed by the participant in clinic. The instrument has not undergone formal psychometric validation; items are analyzed individually and no composite score is computed. Scale: 1 = very poor, 2 = poor, 3 = fair, 4 = good, 5 = very good; higher scores indicate better perceived recovery. Reported by arm as change from baseline at each postoperative visit. Postoperative Days 1, 2, and 10 are assessed in Cohort 1 (facelift, neck lift, brow lift, and combined procedures) only; Postoperative Day 10 data are supportive and exploratory. Unit of measure: score on a scale (1-5).
Measured: Baseline (preoperative) to Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only)
Change From Baseline in Patient-Reported Return to Normal Activities Score (ELIXIR MD Brief Recovery Instrument, Item 5)
Return to normal daily activities rated by the participant on Item 5 of the ELIXIR MD Brief Recovery Instrument, a five-item, study-specific, investigator-designed questionnaire completed by the participant in clinic. The instrument has not undergone formal psychometric validation; items are analyzed individually and no composite score is computed. Scale: 0 = not at all, 1 = partially, 2 = mostly, 3 = fully; higher scores indicate greater return to normal activities. Reported by arm as change from baseline at each postoperative visit. Postoperative Days 1, 2, and 10 are assessed in Cohort 1 (facelift, neck lift, brow lift, and combined procedures) only; Postoperative Day 10 data are supportive and exploratory. Unit of measure: score on a scale (0-3).
Measured: Baseline (preoperative) to Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start12 Oct 2026 (estimated)
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Facial EcchymosisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elixir MD Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rod J Rohrich, MD, FACS, Principal investigator, Dallas Plastic Surgery Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846631
- Sponsor's protocol ID
- CLEAR-001
- Other IDs
- 17261-*MASTER
- Acronym
- CLEAR PBM
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Photobiomodulation With the ELIXIR MD System in Facial Plastic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07846631
- Acronym / sponsor ID
- CLEAR PBM / CLEAR-001
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Elixir MD IncIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 29 Sep 2026 (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 study is testing whether a new light therapy schedule can reduce bruising after facial plastic surgery, compared with the light therapy schedule currently used in the investigator's practice.
Participants having elective facial plastic surgery (such as rhinoplasty, facelift and/or neck lift, blepharoplasty, or brow lift) at the study site may take part. All participants receive photobiomodulation (PBM), a non-contact light therapy already used in the practice as part of routine perioperative care. The study device, the ELIXIR MD system, delivers blue, yellow, red, and near-infrared light and is legally marketed in the United States under a U.S. Food and Drug Administration (FDA) 510(k) clearance, though its use in this study to evaluate reduction of postoperative bruising and swelling is not among its currently cleared uses.
Participants are randomly assigned (1:1) to one of two light therapy schedules: the schedule currently used in the practice, or a new multi-wavelength schedule being studied. Researchers do not know in advance which schedule reduces bruising more; that is the main question this study is designed to answer. The study is not placebo-controlled, because photobiomodulation is already part of routine care at the site; there is no untreated comparison group.
The main measurement is how visible facial bruising is about 7 days after surgery, based on standardized photographs graded by an assessor who does not know which treatment the participant received. The study also looks at facial swelling, pain, patient-reported recovery, and safety (including skin reactions and wound healing).
This is a small pilot study of about 40 participants at a single study site. It is designed to give an early estimate of whether the new schedule helps and to inform a future, larger study. It is not designed or statistically powered to prove that either schedule works.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Current-Practice Photobiomodulation (PBM) Regimen | Active comparator | Device: ELIXIR MD Photobiomodulation (PBM) SystemPerioperative photobiomodulation (PBM) via the ELIXIR MD system, using the regimen currently used in the investigator's practice. Blue 417 nanometers (nm) at 50 milliwatts per square centimeter (mW/cm2) preoperatively; yellow 590 nm (19.1 mW/cm2) at each postoperative session through postoperative day (POD) 7; red 633 nm + yellow 590 nm (64.1 mW/cm2 combined) at POD 10 (Cohort 1 schedule). Cohort 2 (isolated rhinoplasty/blepharoplasty) receives a reduced schedule per the protocol. Each session is 20 minutes, non-contact, at a working distance of 80-120 millimeters (mm). |
| Arm B: Investigational Multi-Wavelength Photobiomodulation (PBM) Regimen | Experimental | Device: ELIXIR MD Photobiomodulation (PBM) SystemPerioperative photobiomodulation (PBM) via the ELIXIR MD system, using the sponsor's proposed multi-wavelength regimen. Blue 417 nanometers (nm) at 50 milliwatts per square centimeter (mW/cm2) preoperatively (identical to Arm A); near-infrared 835 nm + yellow 590 nm (29.1 mW/cm2 combined) from the immediate postoperative session through postoperative day (POD) 2; near-infrared 835 nm + red 633 nm (55 mW/cm2 combined) at POD 7 and POD 10. Each session is 20 minutes, non-contact, at a working distance of 80-120 millimeters (mm). This regimen's benefit and risk profile are less well characterized than Arm A's. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Scheduled for elective facial plastic surgery at the study site: rhinoplasty, facelift and/or neck lift, blepharoplasty, brow lift, or a combination of these procedures.
- Able and willing to attend the perioperative visits and standardized photography required by the protocol.
- Able to read, understand, and provide written informed consent in English.
Key exclusion criteria (7 listed)
- Known photosensitivity disorder, or current use of a photosensitizing medication (for example, systemic isotretinoin, tetracyclines, amiodarone, methoxsalen, or systemic photodynamic agents), though this may be up to treating physician discretion.
- Active facial infection or dermatitis at a treatment site.
- History of keloid formation, or an uncontrolled pigmentary disorder (for example, active melasma or post-inflammatory hyperpigmentation under treatment).
- Pregnancy or breastfeeding.
- Therapeutic anticoagulation (for example, warfarin or a direct oral anticoagulant) or high-dose aspirin or nonsteroidal anti-inflammatory drug (NSAID) use that has not been discontinued preoperatively per the site's standard perioperative protocol.
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 |
|---|---|---|
| ELIXIR MD Photobiomodulation (PBM) SystemNon-contact, continuous-wave light-emitting diode (LED) photobiomodulation (PBM) device delivering blue (417 nanometers [nm]), yellow (590 nm), red (633 nm), and near-infrared (835 nm) light; U.S. Food and Drug Administration (FDA) 510(k) K241293, product code GEX. Delivered at a working distance of 80-120 millimeters (mm) in 20-minute (1,200 second) sessions. In this study, delivered per the Arm A schedule: blue 417 nm preoperatively; yellow 590 nm at each postoperative session through postoperative day (POD) 7; red + yellow at POD 10 (Cohort 1); a reduced schedule applies to Cohort 2. This is the regimen currently used in the investigator's practice, unchanged by study participation. | Device | Arm A: Current-Practice Photobiomodulation (PBM) Regimen |
| ELIXIR MD Photobiomodulation (PBM) SystemNon-contact, continuous-wave light-emitting diode (LED) photobiomodulation (PBM) device delivering blue (417 nanometers [nm]), yellow (590 nm), red (633 nm), and near-infrared (835 nm) light; U.S. Food and Drug Administration (FDA) 510(k) K241293, product code GEX. Delivered at a working distance of 80-120 millimeters (mm) in 20-minute (1,200 second) sessions. In this study, delivered per the Arm B schedule: blue 417 nm preoperatively (identical to Arm A); near-infrared + yellow from the immediate postoperative session through postoperative day (POD) 2; near-infrared + red at POD 7 and POD 10. This is the sponsor's proposed regimen; its benefit and risk profile are less well characterized than Arm A's. | Device | Arm B: Investigational Multi-Wavelength Photobiomodulation (PBM) Regimen |
Primary outcome
Postoperative Facial Bruising (Bruise Visibility Scale)
Time frame: Postoperative Day 7 (±2 days)
Graded from standardized photographs (frontal and bilateral oblique views) using the Bruise Visibility Scale (BVS; Scafide et al., 2021), a 1-5 visual analogue scale developed and validated for in-person assessment of accidental bruises on the arms and legs. In this study the BVS is applied to standardized postoperative facial photographs, a context (face rather than limb, photograph rather than in-person, surgical rather than blunt-trauma etiology) in which it has not been formally validated; no claim of validation for this application is made. Grading is performed by a blinded assessor after all Postoperative Day 7 visits are complete.
11 secondary outcomes
Postoperative Facial Swelling (Investigator-Adapted Ordinal Scale)
Time frame: Postoperative Day 7 (±2 days)
Postoperative Pain Intensity (Numeric Rating Scale)
Time frame: Baseline (preoperative), Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only)
Number of Participants With Analgesic Use at Each Visit
Time frame: Baseline (preoperative), Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only)
Change From Baseline in Patient-Reported Swelling Score (ELIXIR MD Brief Recovery Instrument, Item 2)
Time frame: Baseline (preoperative) to Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only)
Number of Participants With Adverse Events
Time frame: From consent through final study visit (Postoperative Day 7, or Postoperative Day 10 for Cohort 1 if attended)
Number of Participants With Treatment-Area Erythema
Time frame: From consent through final study visit (Postoperative Day 7, or Postoperative Day 10 for Cohort 1 if attended)
Number of Participants With Treatment-Area Pigmentary Change
Time frame: From consent through final study visit (Postoperative Day 7, or Postoperative Day 10 for Cohort 1 if attended)
Number of Participants With Wound Complications
Time frame: From consent through final study visit (Postoperative Day 7, or Postoperative Day 10 for Cohort 1 if attended)
Change From Baseline in Patient-Reported Bruising Score (ELIXIR MD Brief Recovery Instrument, Item 3)
Time frame: Baseline (preoperative) to Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only)
Change From Baseline in Patient-Reported Overall Recovery Score (ELIXIR MD Brief Recovery Instrument, Item 4)
Time frame: Baseline (preoperative) to Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only)
Change From Baseline in Patient-Reported Return to Normal Activities Score (ELIXIR MD Brief Recovery Instrument, Item 5)
Time frame: Baseline (preoperative) to Postoperative Day 1, Postoperative Day 2, Postoperative Day 7 (±2 days), and Postoperative Day 10 (Days 1, 2, and 10 in Cohort 1 only)
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 29 Sep 2026.
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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.
Rod J Rohrich, MD, FACS principal investigator
Dallas Plastic Surgery Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELIXIR MD Photobiomodulation (PBM) System in people with Postoperative Facial Ecchymosis and Postoperative Facial Edema, run by Elixir MD Inc at 1 site in United States.
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 7 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: opening soon, as of the sponsor's last update on 29 Sep 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 United States. 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?
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 Rod J Rohrich, MD, FACS (214-821-9114, rod.rohrich@dpsi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Facial Bruising (Bruise Visibility Scale) (time frame: Postoperative Day 7 (±2 days)). 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 29 Sep 2026.