Perioperative Photobiomodulation in Facial Plastic Surgery (CLEAR PBM)

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).

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.

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.

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.

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.

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).

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).

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.

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).

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.

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.

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.

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.

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).

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).

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).