An interventional study of ELIXIR MD Photobiomodulation (PBM) System and ELIXIR MD Photobiomodulation (PBM) System in Postoperative Facial Ecchymosis and Postoperative Facial Edema, sponsored by Elixir MD Inc. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Elixir MD Inc · Not applicable, Interventional, and Supportive care
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.
Elixir MD Inc is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Device: ELIXIR MD Photobiomodulation (PBM) System
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.
Device: ELIXIR MD Photobiomodulation (PBM) System
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.
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.
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.
Time frame: Postoperative Day 7 (±2 days)
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).
Time frame: 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).
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
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.
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)
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).
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
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.
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
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.
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
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.
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
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.
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)
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).
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)
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).
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)
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).
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)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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