laxity, wrinkle laxity, wrinkle, hyaluronic acid
Conditions
Interventions
Each participant will receive a single treatment with a hybrid complex of high- and low-molecular-weight hyaluronic acid via injection. Prior to the procedure, participants will apply a topical anesth
Experimental Device
Hybrid complex of high and low molecular weight hyaluronic acid injection
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged between 30 and 60 years. 2. Participants who voluntarily agree to participate in the study. 3. Participants who wish to improve facial and neck skin concerns, specifically hyperpigmentation and wrinkles. 4. Participants who have undergone facial and neck skin evaluation by a specialist in dermatologic surgery using the Glogau classification of photoaging.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding participants. 2. Participants with a history of platelet disorders, coagulation abnormalities, anemia, liver disease, cancer, or autoimmune disorders. 3. Participants who smoke or have a history of heavy alcohol consumption. 4. Participants with dermatitis, wounds, or skin infections on the face. 5. Participants with a history of allergy to local anesthetics. 6. Participants with a history of hormone therapy or contraceptive use (injectable or oral), or regular use of NSAIDs. 7. Participants with a history of taking medications that affect blood clotting, such as aspirin or anticoagulants. 8. Participants who have undergone facial lifting procedures (energy-based devices or thread lifting) within 12 months prior to study enrollment. 9. Participants who have received facial dermal filler injections within 24 months prior to study enrollment. 10. Participants who have received platelet-rich plasma (PRP) injections to the face within 12 months prior to study enrollment. 11. Participants who have received botulinum toxin injections to the face within 6 months prior to study enrollment. 12. Participants who have undergone collagen-stimulating laser treatments on the face (e.g., Picosecond laser, Erbium: YAG laser, Fractora, Laser E-matrix) within 12 months prior to study enrollment. 13. Participants with a history of hypertrophic scars or keloids. 14. Participants with diagnosed psychiatric disorders as evaluated by a psychiatrist. 15. Participants who do not consent to photography for treatment outcome evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrinkles Baseline, 1, 3, 6, 9, and 12 months after treatment. Antera3D,Skin Texture Baseline, 1, 3, 6, 9, and 12 months after treatment Antera3D | — |
Secondary
| Measure | Time frame |
|---|---|
| Volume change compared to baseline 1, 3, 6, 9, and 12 months Quantificare,Skin Elasticity Baseline, 1, 3, 6, 9, and 12 months after treatment Cutometer,Melanin and Erythema Index Baseline, 1, 3, 6, 9, and 12 months after treatment Mexameter,Skin Hydration Baseline, 1, 3, 6, 9, and 12 months after treatment Corneometer,Individual typology angle (ITA) Baseline, 1, 3, 6, 9, and 12 months after treatment Colorimeter,Sebum Baseline, 1, 3, 6, 9, and 12 months after treatment Sebumeter,Participant Self-Assessment 1, 3, 6, 9, and 12 months Quartile Scale,Physician assessment 1, 3, 6, 9, and 12 months Quartile scale,Safety Immediate, 1, 3, 6, 9, and 12 months after treatment Adverse event | — |
Countries
Thailand
Contacts
Public ContactRungsima Wanitphakdeedecha
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed