ELIXIR MDTM Satisfaction Clinical Trial

Efficacy and Safety of the Photobiomodulation Device ELIXIR in Postoperative Plastic Surgery: A Randomized Clinical Trial

This study aims to assess patient satisfaction from the use of the ELIXIR MD™ photobiomodulation (PBM) device in the perioperative period of facial and body reconstructive surgery at Cedars-Sinai Medical Center. The ELIXIR MD™ device is FDA-cleared (510(k), product code GEX) and delivers low-level, multi-wavelength light energy to targeted tissues to promote cellular repair, reduce inflammation, and enhance patient recovery. Participants undergoing elective facial or body plastic surgery will be randomized 1:1 to receive either active ELIXIR MD™ PBM treatment or sham (placebo) treatment. A total of 8 treatment sessions are scheduled: one preoperative session and sessions on POD 0, 1, 2, 3, 5, 7, and 10, each lasting 20 minutes. A final follow-up visit occurs at POD 30. Patient-reported outcomes (FACE-Q and Body Metrics Questionnaire), blinded edema and ecchymosis assessments via standardized photography, pain scores (VAS), and time to return to usual activities will be evaluated. The study enrolls 148 participants (74 per arm) with equal representation of facial and body surgery patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Complications; Plastic Surgery
• Intervention / Treatment: Device: Photobiomodulation

• Study Type: Interventional
• Enrollment (Estimated): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged > 18 years old
4. In good general health as evidenced by medical history
5. Patients presenting to the plastic surgery department at Cedars Sinai for facial or body plastic surgery
6. Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

1. Patient under 18 years of age
2. Blepharoplasty (the need for protective eyewear makes it impossible to include this surgery)
3. Antecedent of carcinoma, pregnancy, epilepsy, and thyroid conditions
4. Antecedent of photosensitive disease such as Lupus, porphyria, xeroderma pigmentosum
5. Patient taking medications that cause photosensitivity, including: Chlorpromazine (unless not taken within last 8 days), Griseofulvin (unless not taken within last 5 days), Isotretinoin (unless not taken within last 6 months), Tetracyclines (unless not taken within last 5 days), Methotrexate (unless not taken within last 3 days), Amiodarone (at physician's discretion), Hydroquinone (unless not taken within last 2 weeks)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active ELIXIR MD PBM; Participants receive active ELIXIR MD photobiomodulation (PBM) treatment using the ELIXIR MD device. Sessions include Detox protocol pre-op, Cellular Repair protocol POD 0-7, and NeoXcell or Roxium protocol at POD 10. Each session is 20 minutes.	Device: Photobiomodulation; The ELIXIR MD™ photobiomodulation (PBM) device is an FDA-cleared (510(k), GEX classification) medical-grade light therapy system. It delivers low-level, multi-wavelength light energy (blue 417nm, yellow 590-599nm, red 633nm) to targeted tissues. Three protocols are used: Detox (417nm blue light, pre-op), Cellular Repair (599nm yellow light, POD 0-7), and NeoXcell (633+590nm, POD 10 for light skin types Fitzpatrick I-III) or Roxium (417+590nm, POD 10 for darker skin types Fitzpatrick IV-V). Each session is 20 minutes. Manufactured by Yassen Wellness LLC, regulation 21 CFR 878.4810.
Sham Comparator: Sham/Placebo Control; Participants undergo identical sessions with the ELIXIR MD device with light output disabled. Operational cues (fan, sound, indicator) are mimicked. All participants wear protective eyewear and cannot determine if the device is activated.	Device: Photobiomodulation; The ELIXIR MD™ photobiomodulation (PBM) device is an FDA-cleared (510(k), GEX classification) medical-grade light therapy system. It delivers low-level, multi-wavelength light energy (blue 417nm, yellow 590-599nm, red 633nm) to targeted tissues. Three protocols are used: Detox (417nm blue light, pre-op), Cellular Repair (599nm yellow light, POD 0-7), and NeoXcell (633+590nm, POD 10 for light skin types Fitzpatrick I-III) or Roxium (417+590nm, POD 10 for darker skin types Fitzpatrick IV-V). Each session is 20 minutes. Manufactured by Yassen Wellness LLC, regulation 21 CFR 878.4810.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FACE-Q and Body Metrics Questionnaire Score	Patient-reported satisfaction assessed using FACE-Q (facial surgery) or Body Metrics Questionnaire (body surgery) scores, measured before and after each session	From baseline (POD0) to postoperative day 10 (POD10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mid-term Satisfaction Score (FACE-Q or Body Metrics Questionnaire)	Mid-term patient-reported satisfaction assessed using FACE-Q (facial surgery) or Body Metrics Questionnaire (body surgery) at postoperative day 30	Postoperative day 30 (POD30)
Blinded Edema Score on Standardized Photographs	Blinded evaluation of edema by independent evaluator using standardized, de-identified photographs assessed at POD1, 3, 7, 10, and 30	POD1, 3, 7, 10, and 30
Percent Bruised Area (Ecchymosis)	Percent of bruised area evaluated from standardized, de-identified photographs by independent blinded evaluator	POD1, 3, 7, 10, and 30
Days from Surgery to Self-Reported Return to Usual Activities	Number of days from surgery date to self-reported resumption of usual daily activities, collected at POD10 and POD30	POD10 and POD30
Incidence of Device-Related Adverse Events (AEs), Serious Adverse Events (SAEs), and UADEs	Incidence and severity of device-related adverse events, serious adverse events, and unanticipated adverse device effects (UADEs) through postoperative day 30	Through postoperative day 30 (POD30)
Visual Analog Scale (VAS) Pain Score	Patient-rated pain on a 0-10 Visual Analog Scale (VAS) after each session and at 1 month (0 = no pain, 10 = worst pain imaginable)	POD1, 2, 3, 5, 7, 10, and 30

Collaborators and Investigators

• Sponsor: Elixir MD Inc
• Collaborators: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: STUDY00004528

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes