ELIXIR MDTM Satisfaction Clinical Trial

NCT07676643 · tracked via the Priya Life Science USA tracker

Sponsor

Elixir MD Inc

Phase

Not applicable

Started

2025-12-09

Last updated

2026-06-30

Condition(s) studied

Postoperative ComplicationsPlastic Surgery

Investigational drug(s) / intervention(s)

Photobiomodulation

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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)

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Cedars-Sinai Medical Center	Los Angeles	California

More Elixir MD Inc trials in the USA

Patient Satisfaction and Recovery Outcomes Associated With Perioperative ELIXIR MD Use Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07676643 on ClinicalTrials.gov ↗ ← All trials in the USA