Female subjects exhibiting signs of senile facial skin deterioration Female subjects exhibiting signs of fine lines deep wrinkles (rhytides) Female subjects exhibiting signs of reduced skin elasticity Female subjects exhibiting signs of skin dyspigmentation Female subjects exhibiting signs of uneven skin texture. Skin Wrinkling , aging, skin, dyspigmentation
Conditions
Interventions
Autologous adipose-derived stem cells 10M Cells in 5 ml
Dose : 10M Cells in 5 ml
Frequency : 3 injections every 4 weeks.
Duration of intervention
1. Screening and Baseline Phase (Weeks 0-2) : Informe
Experimental Biological/Vaccine
Skinozel
Sponsors
Medeze Group PCL
Eligibility
Sex/Gender
Female
Age
35 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Thai female aged 35 to 50 years , 2.Patients exhibiting signs of senile facial skin deterioration, such as fine lines, deep wrinkles (rhytides), reduced skin elasticity, skin dyspigmentation, or uneven skin texture.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women. 2.Individuals with a history of allergy to local anesthetics, penicillin, cephalosporins, non-steroidal anti-inflammatory drugs (NSAIDs), or Betadine (povidone-iodine). 3.Individuals with underlying medical conditions, including autoimmune diseases, malignancy (cancer), or severe infectious diseases such as HIV/AIDS, viral hepatitis, syphilis, HTLV-1/2, CMV, or pulmonary tuberculosis. 4.Individuals currently or previously using anticoagulants, immunosuppressants, biologics, targeted therapies, or chemotherapy. 5.Individuals currently or previously using anticoagulants, immunosuppressants, biologics, targeted therapies, or chemotherapy. 6.Presence of an abdominal hernia. 7. History of major surgery within the preceding 6 months. 8.History of cerebral infarction (stroke) or myocardial infarction (heart attack) within the preceding 6 months. 9.Subjects with uncontrolled diabetes mellitus. 10.who have received facial aesthetic procedures such as botulinum toxin injection, fillers, focused ultrasound, radiofrequency (RF) treatments, or a surgical facelift within 6 months prior to or during the study period. 11. Individuals with a history of keloid formation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Facial skin rejuvenation Every 4 weeks after the first injection for 26 weeks. GAIS Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Facial skin rejuvenation Every 4 weeks after the first injection for 26 weeks. Objective skin analysis/ Visia system and Antera 3 D System | — |
Countries
Thailand
Contacts
Public ContactDr.Pimsiri Anansiriphan
Vachira Phuket Hospital
Outcome results
None listed