Autologous Facial Fat Grafting Study
The goal of this study is to specifically examine changes in facial skin appearance after facial fat grafting with autologous fat tissue that has either been washed with sterile saline before injecting, or left unwashed. This will be testing two variations of a standard of care surgical procedure, in two cohorts of subjects. One group will receive washed fat, and one group will receive unwashed fat, to both sides of the face. There are no experimental devices, drugs, or biological agents being used in this study. All fat tissue is autologous from the subjects treated. Significance: This study will provide evidence that may directly impact clinical practice for a common procedure in plastic surgery. Regardless of whether the null hypotheses is accepted or rejected, the data will be of direct clinical use and impact practice in the operating room.
Conditions:
🦠 Facial Skin Texture 🦠 Facial Skin Pigmentation
🗓️ Study Start (Actual) 17 October 2022
🗓️ Primary Completion (Estimated) July 2025
✅ Study Completion (Estimated) January 2026
👥 Enrollment (Estimated) 26
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Ability to perform informed consent
    • 2. Healthy female adults, from 35 to 70 years of age
    • 3. Fitzpatrick Skin Type Scale scores \< 3.
    • 4. FWAS-greater than moderate, equal to or greater than 4
    • 5. Noticeable Physical signs of facial aging and sun damage including skin wrinkles, loss of elasticity and pigmentary changes, with greater than mild (≥4 on a 0 to 9 scale) signs of the following, per investigator discretion
    • 1. Facial wrinkles (periorbital//periorbital//cheek)
    • 2. Dyschromia (hyperpigmentation//uneven skin tone)
    • 3. Rough skin texture (visual skin roughness//pore sizes)
    • 6. Willingness to undergo the proposed treatment and comply with study procedures.
    • 7. Negative pregnancy urine dip test (as indicated-unless s/p hysterectomy or past menopause documentation can be sourced to research chart.)
    • 8. Willingness to avoid the use of laser, IPL, Botox (6 months), injectable fillers or other surgical cosmetic procedures on the face for 6 months ducts
    • 9. Ability to produce sufficient fat tissue from donor site during harvest (up to a maximum of 1 liter)

    Exclusion Criteria:

    • 1. Age \< 35 or \> 70 years of age
    • 2. Any medical condition that would preclude safe administration of anesthesia and safe conduct of the adipose harvest procedure (such as an uncontrolled bleeding disorder or severe pulmonary disease), per investigator discretion.
    • 3. Active infection on the face (e.g., acne, HSV (herpes simplex), etc.,) per investigator discretion.
    • 4. Female in pregnancy (positive pregnancy-test performed before inclusion) or lactation or without effective contraception)
    • 5. Received laser, IPL, botox (6 months), injectable fillers or other surgical cosmetic procedures on the face within 12 months of study consent and screening date. -prohibited for 6 months
    • 6. Acutane use within past 12 months
    • 7. Individuals with any contraindications of autologous lipografting, such as cutaneous rashes or infection in the area of intended fat harvest, lack of available donor fat, or other factors that, in the determination of the investigator, would be considered a contraindication.
    • 8. Individuals diagnosed with known allergies to skin care products, topical antibiotics, adhesives, bandages, lidocaine, epinephrine, or other agents that might be used in the study
    • 9. Individuals with any disease state or inappropriate physical skin condition (e.g., active/history of psoriasis, active eczema, excessive hair, scars, tattoos, etc. on face) that might impair evaluations or increase the health risk to the subject by participation in the opinion of the Investigator
    • 10. Individuals with a history of immunosuppression/immune deficiency disorders/ known or suspected defect of healing (including HIV infection or AIDS)
    • 11. Individuals with an uncontrolled disease such as hypertension, hyperthyroidism, or hypothyroidism, which may impact safety. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, which in the opinion of the Investigator, may create safety concerns or interfere with the study.
    • 12. Individuals currently taking substances known to affect bleeding time, which in the opinion of the Investigator, may create safety concerns or interfere with the study (e.g., aspirin, Heparin, Warfarin, Plavix, supplements, etc.).
    • 13. Individuals currently and chronically taking substances known to impair the immune system at doses anticipate to have a systemic effect on wound healing (e.g., corticosteroids, immunosuppressant, etc. or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) within 30 days of the study start and in the discretion of the PI would impact the results of the study. Steroid treatments that would not be expected to impact study results could include steroid inhaler, nasal spray, eyedrops, topical creams used in areas outside of the face, or transient oral dose of steroids to treat acute conditions (eg pulsed oral dose for respiratory airway constriction or skin rash)
    • 14. Individuals with a history of documented keloid scar formation, prominent skin lesions or scars that would render data collection and aesthetic evaluation impossible. The investigator will make that determination based on examining other scars and reviewing any history of treatment for keloid lesions.
    • 15. Individuals with a diagnosis of diabetes
    • 16. Subject participating in another interventional clinical trial assessing treatments that may interfere with the accuracy of data collection for this study within 1 month of Visit 1
    • 17. The inability to obtain sufficient fat from the donor site during the harvest to allow the autologous fat tissue processing prior to facial injection.
Ages Eligible for Study: 35 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 March 2022
  • First Submitted that Met QC Criteria 28 July 2022
  • First Posted 1 August 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 December 2023
  • Last Update Posted 11 December 2023
  • Last Verified December 2023