Middle face filling
Conditions
Interventions
Group A:SVF-Gel transplantation
Group B:Hyaluronan filling
Sponsors
Tongji Hospital Affiliated to Tongji University
Eligibility
Sex/Gender
Female
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese women aged 25-65; 2. After evaluation by the doctor, the patient was suitable for middle facial volume expansion surgery; 3. Willing to undergo facial autologous fat injection, including liposuction to obtain adipose tissue, with sufficient adipose tissue stock at the tissue supply site assessed by the doctor, or willing to undergo hyaluronic acid skin filler injection; 4. With the following indications: A. infraorbital pigment spot density (>= 3 degrees, Asian Type) B. Infraorbital wrinkles (>= 3 Skin Aging Atlas, Asian Type) C. Skin pore size (>= 2 Skin Aging Atlas, Asian Type) 5. Be informed and understand the purpose and procedures of the study; 6. Willing and able to comply with the requirements and schedule of the study; 7. Willing to sign the informed consent; 8. Willing to sign a photo authorization form.
Exclusion criteria
Exclusion criteria: 1. Received lasers, intense pulsed light, botulinum toxin, skin filler injections, and other surgical cosmetic operations within one year before participating in the study. 2. Received chemical peeling, microcrystalline dermabrasion, water dermabrasion and other anti-aging facial treatments within 4 weeks before participating in the study. 3. Have received facial hot wax depilation or used other facial depilation treatments within 2 weeks before participating in the study. 4. Received facial laser hair depilation treatments within 4 weeks before participating in the study. 5. Used anti-wrinkle, whitening products or any other products / drugs known to affect skin aging or color difference within 4 weeks before participating in the study. 6. The prescription strength skin lightening product was used within 4 months before participating in the study. 7. Used ret-a, retin-amicro, Renova, avita, avage, tazorac, soriatane, or differein within 3 months prior to study participation. 8. Accutane was used within 12 months before participating in the study. 9. Having or suspected of having skin rehabilitation defects. 10. Diagnosed allergy to skin care products, local antibiotics, adhesives, bandages, lidocaine, adrenaline, or latex. 11. Having any disease state or inappropriate physical skin condition (e.g., history of psoriasis, rosacea, nevus, chloasma, eczema, excessive hair, scars, tattoos, etc.), which may weaken the assessment or increase the prevalence. The health risks to the subjects through the opinions of the participating researchers. 12. Sunburn or tanning on the face. 13. During the study period, the patient was unwilling to avoid daily sunlight exposure and use sunbeds and sunburn products. 14. History of immunosuppressive / immunodeficiency diseases (including HIV infection or AIDS) or currently using immunosuppressive drugs (e.g., azathioprine, belimumab, cyclophosphamide, enbrel, yicun, humira, mycophenolate mofetil, methotrexate, prednisone, remicade, stellara). 15. Have other uncontrolled conditions such as active hepatitis, diabetes, hypertension, hyperthyroidism or hypothyroidism. Even individuals with controlled multiple health conditions such as diet, medications, etc., may have been excluded from participation. 16. Currently, taking substances that affect the timing of bleeding (e.g., aspirin, heparin, warfarin, plavix, etc.). 17. Currently, taking a substance known to damage the immune system (e.g., corticosteroids, immunosuppressive agents, etc.) within 30 days before the start of the study. 18. Other procedures are planned during the study. 19. Unable to be contacted by telephone in case of emergency. 20. Participated in or is currently participating in another clinical study involving the facial region within 30 days prior to study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of clinical skin rejuvenation indicators (infraorbital areas); | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of clinical skin rejuvenation indicators (other areas of the face);Imaging analysis of the Antera infraorbital region;Vectra three-dimensional image analysis;Subject Satisfaction Scale (SSA);Global Aesthetic Improvement Scale (GAIS); | — |
Countries
China
Contacts
Public ContactHaiyan Cui
Shanghai Tongji Hospital
Outcome results
None listed