Facial aging
Conditions
Interventions
Experimental group:1. Autologous red blood cell-derived extracellular vesicle (RBC-EV) injections for facial rhytides.
2. Treatment schedule: one course consists of three intradermal sessions spaced
50 000 × g, 60 min at 4 °C), washed once, and finally re-suspended in 2 mL sterile 0.9 % saline for immediate use.
4. Injection procedure
(1) Thirty eligible subjects are enrolled. Baseline VIS
Sponsors
The Second Affiliated Hospital of Hainan Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male or female cosmetic subjects aged >=18 years with Fitzpatrick skin types III or IV. 2. Aged 18–60 years at the time of informed consent. 3. Personally motivated to improve their facial wrinkles. 4. Glogau photoaging grade II . 5. Never received any non-absorbable filler injections or facial implants. 6. No laser resurfacing within the past year. 7. Will not undergo laser resurfacing or any other local filler or facial implant procedures during the study period.
Exclusion criteria
Exclusion criteria: 1. Any prior injection of non-absorbable fillers or facial implants at any time. 2. Laser resurfacing performed within the past 12 months. 3. Individuals who are uncertain about the study treatment or who have overt psychiatric or psychological disorders. 4. History of infection within 1 month before screening that required hospitalization and/or antibiotic therapy, or current use of systemic corticosteroids, immunosuppressants, or cytotoxic agents. 5. Diagnosis of hyper- or hypothyroidism within 1 year before screening and still on medication; or previous thyroid disease with TSH >1.2×ULN or =5 units (1 unit = 360 mL beer, 45 mL spirits, or 120 mL wine). 8. Severe or unstable cardiovascular, respiratory, hepatic, renal, hematologic, endocrine, central-nervous-system, immune-deficiency, or malignant disease. 9. Use of antirheumatic drugs, including methotrexate or other antimetabolites. 10. History within the past 5 years of platelet disorders, bone-marrow aplasia, anemia, or malignancy. 11. Pregnant or breastfeeding women, or women planning pregnancy within 1 year. 12. Active dermatitis or skin infection at intended injection sites. 13. Known contraindications or hypersensitivity to any component of the study treatment. 14. Subjects whom the investigator deems unsuitable for the trial. 15. Any other condition that would preclude safe injection therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Facial wrinkles;Skin smoothness;Adverse Event (AE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Global aesthetic improvement (GAIS); | — |
Countries
China
Contacts
Public ContactXie Hongju
The Second Affiliated Hospital of Hainan Medical University
Outcome results
None listed