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