Periorbital skin aging, tear trough deformity, and under-eye volume loss related to facial aging Skin Aging Face Eye (subheading: anatomy, skin under eyes) Injections, Subcutaneous Biocompatible Materials Polyesters Dermal Fillers Esthetics Rejuvenation Patient Satisfaction Adverse Effects Prospective Studies Adult
Conditions
Interventions
PDLLA injection: 1 vial mixed with 9 mL sterile water and 1 mL lidocaine (without adrenaline), total 10 mL. Administered using a 25G blunt cannula with linear retrograde fanning technique into the sub
Experimental Drug
Sponsors
Dhurakij Pundit University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Thai nationality 2. Male or female participants 3. Aged between 20 to 50 years 4. Seeking aesthetic rejuvenation in the tear trough area 5. In good general physical and mental health 6. Willing to participate in the entire research project and comply with the required assessments and questionnaires 7. Voluntarily consents to participate in the research study, including data collection and disclosure processes, until completion of the study
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Currently pregnant or breastfeeding 2. Open wounds, active infections, or scars in the area designated for PDLLA injection 3. History of keloid formation 4. Presence of underlying diseases such as bleeding disorders or genetic collagen synthesis disorders 5. History of lower eyelid surgery 6. Received hyaluronic acid filler, collagen biostimulator, botulinum toxin, or mesotherapy in the under-eye area within 6 months prior to enrollment 7. Received laser or radiofrequency-based treatments that stimulate collagen in the under-eye area within 6 months prior to enrollment, including monopolar radiofrequency and microneedle RF 8. History of allergy to topical or injectable anesthetics 9. Known allergy to components of the treatment substance, including polydl-lactic acid (PDLLA) 10. Use of medications, vitamins, or supplements that affect blood coagulation within 2 weeks prior to the procedure, such as vitamin C, vitamin E, fish oil, antiplatelets, or anticoagulants 11. Concurrent participation in another clinical research study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tear tough volume restoration Day 0 (Baseline), Day 1, Day 2, Day 3, Week 1, Week 2, Month 1, Month 3 Wilcoxon Signed-Rank Test,roughness Day 0 (Baseline), Day 1, Day 2, Day 3, Week 1, Week 2, Month 1, Month 3 Wilcoxon Signed-Rank Test,Pigmentation Day 0 (Baseline), Day 1, Day 2, Day 3, Week 1, Week 2, Month 1, Month 3 Wilcoxon Signed-Rank Test,Wrinkles Day 0 (Baseline), Day 1, Day 2, Day 3, Week 1, Week 2, Month 1, Month 3 Wilcoxon Signed-Rank Test | — |
Secondary
| Measure | Time frame |
|---|---|
| GAIS (Global Aesthetic Improvement Scale) scores Day 0 (Baseline), Day 1, Day 2, Day 3, Week 1, Week 2, Month 1, Month 3 Wilcoxon Signed-Rank Test | — |
Countries
Thailand
Contacts
Public ContactNutcha Sanongkunworakul
Dhurakij Pundit University
Outcome results
None listed