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Active, Not Recruiting

NCT Number: NCT07676643

ELIXIR MDTM Satisfaction 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Plastic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient under 18 years of age
  • Blepharoplasty (the need for protective eyewear makes it impossible to include this surgery)
  • Antecedent of carcinoma, pregnancy, epilepsy, and thyroid conditions
  • Antecedent of photosensitive disease such as Lupus, porphyria, xeroderma pigmentosum
  • 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)

Treatment and study plan

Photobiomodulation

Device

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.

Primary outcomes

  1. Change in FACE-Q and Body Metrics Questionnaire Score

    Time frame: 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

Secondary outcomes

  1. Mid-term Satisfaction Score (FACE-Q or Body Metrics Questionnaire)

    Time frame: Postoperative day 30 (POD30)

    Mid-term patient-reported satisfaction assessed using FACE-Q (facial surgery) or Body Metrics Questionnaire (body surgery) at postoperative day 30

  2. Blinded Edema Score on Standardized Photographs

    Time frame: POD1, 3, 7, 10, and 30

    Blinded evaluation of edema by independent evaluator using standardized, de-identified photographs assessed at POD1, 3, 7, 10, and 30

  3. Percent Bruised Area (Ecchymosis)

    Time frame: POD1, 3, 7, 10, and 30

    Percent of bruised area evaluated from standardized, de-identified photographs by independent blinded evaluator

  4. Days from Surgery to Self-Reported Return to Usual Activities

    Time frame: POD10 and POD30

    Number of days from surgery date to self-reported resumption of usual daily activities, collected at POD10 and POD30

  5. Incidence of Device-Related Adverse Events (AEs), Serious Adverse Events (SAEs), and UADEs

    Time frame: Through postoperative day 30 (POD30)

    Incidence and severity of device-related adverse events, serious adverse events, and unanticipated adverse device effects (UADEs) through postoperative day 30

  6. Visual Analog Scale (VAS) Pain Score

    Time frame: POD1, 2, 3, 5, 7, 10, and 30

    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)

Sponsors and collaborators

Lead sponsor

Elixir MD Inc

Industry

Collaborators

  • Cedars-Sinai Medical Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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