Infraorbital Hollowness, Under eye hollowness Infraorbital Hollowness, Hyaluronic Acid Filler
Conditions
Interventions
Each participants will received single treatment using a cannula technique targeting the SOOF and subdermal plane
Experimental Device
Non Cross Linked Hyaluronic Acid Filler
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Participants aged 30 to 60 years, both male and female. 2. Participants with moderate to severe infraorbital hollows, as assessed by a dermatologist using the Allergan Infraorbital Hollows Scale. 3. Participants of Thai Asian ethnicity.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding participants 2. Participants with underlying conditions including platelet disorders, coagulopathy, anemia, liver disease, malignancy, or immunodeficiency. 3. Participants who smoke heavily or consume excessive alcohol 4. Participants with active dermatitis, wounds, or facial skin infection. 5. Participants with a history of allergy to local anesthetics. 6. Participants taking hormonal therapy, oral contraceptives, or regular NSAIDs. 7. Participants taking anticoagulant or antiplatelet medications (e.g., aspirin). 8. Participants who underwent facial tightening procedures or thread lifting within 6 months. 9. Participants who received dermal filler injections within 6 months. 10. Participants who received platelet-rich plasma (PRP) injections within 6 months. 11. Participants who received botulinum toxin injections within 6 months. 12. Participants who underwent collagen-stimulating laser treatments within 6 months. 13. Participants with a history of keloid or hypertrophic scarring. 14. Participants with psychiatric disorders diagnosed by a psychiatrist. 15. Participants unwilling to allow clinical photography for evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Undereye volume change compared to baseline Immediate, 1, 3, 6, 9 and 12 months 3D imaging device,Infraorbital Hollowness severity Baseline, Immediate, 1, 3, 6, 9 and 12 months Allergan Infraorbital Hollows Scale Descriptors | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin pliability Baseline, 1, 3, 6, 9 and 12 months Cutometer,Skin elasticity Baseline, 1, 3, 6, 9 and 12 months Cutometer,Hydration Baseline, 1, 3, 6, 9 and 12 months Corneometer,individual typology angle Baseline, 1, 3, 6, 9 and 12 months Colorimeter,Skin quality (wrinkles, texture, pore, fine lines, folds, pigmentation, redness) Baseline, 1, 3, 6, 9 and 12 months Antera,Ultrasonographic findings Immediate, 1, 3, 6, 9 and 12 months Ultrasound performed by trained dermatologist,Patients improvement Immediate, 1, 3, 6, 9 and 12 months Patients improvement scale,Physician assessment Immediate, 1, 3, 6, 9 and 12 months Physician improvement scale | — |
Countries
Thailand
Contacts
Public ContactRungsima Wanitphakdeedecha
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed