Patients with facial skin laxity. facial skin laxity, Calcium Hydroxylapatite, CaHA, Hyaluronic acid, HA, lifting
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged between 25 and 60 years, both male and female. 2. Patients must be evaluated by a dermatologist or dermatologic surgeon using the Glogau Classification of Photoaging, with a score of moderate or higher. 3. Thai nationality and Asian ethnicity. 4. Patients who voluntarily consent to participate in the study and agree to receive dermal filler injections, with the dosage and treatment areas determined by the study protocol.
Exclusion criteria
Exclusion criteria: 1. Patients who are pregnant, lactating, and breastfeeding 2. Patients with a history of medical conditions such as abnormal platelet counts, blood clotting disorders, anemia, liver disease, cancer, or autoimmune disorders. 3. Patients who smoke or heavy alcohol consumption (14 drinks/week). 4. Patients with other skin diseases, or having infection at the area of face 5. Patients with history of local anasthesia allergy 6. Patients with a history of taking hormones or oral contraceptives, or those who regularly take NSAIDs (nonsteroidal anti-inflammatory drugs). 7. Patients with a history of taking medications that affect blood clotting, such as aspirin and anticoagulants. 8. Patients who have undergone facial lifting procedures, such as non-surgical lifting tools or thread lifting, within the 6 months. 9. Patients who have received dermal filler injections in the facial area within the 6 months. 10. Patients who have received platelet-rich plasma (PRP) injections in the facial area within the 6 months. 11. Patients who have received botulinum toxin injections in the facial area within the 6 months. 12. Patients who have undergone collagen-stimulating laser treatments in the facial area, such as Picosecond laser, Erbium: YAG laser, Fractora, or Laser E matrix, within the 6 months. 13. Patients with hypertrophic scar or keloid 14. Patients diagnosed with any mental health disorder by a psychiatrist. 15. Patients who do not consent to having photographs taken for the purpose of evaluating the treatment outcomes. 16. Patients with a known allergy to calcium hydroxylapatite.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volume analysis Baseline, 1, 3, 6, 9 and 12 months after complete the treatment. Quantificare and Vectra H2,Average Wrinkle and Texture improvement Baseline, 1, 3, 6, 9 and 12 months after complete the treatment. Antera 3D,wrinkle severity rating scale (WSRS) Baseline, 1, 3, 6, 9 and 12 months after complete the treatment. wrinkle severity rating scale (WSRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin elasticity Baseline, 1, 3, 6, 9 and 12 months after complete the treatment. Cutometer,Skin hydration Baseline, 1, 3, 6, 9 and 12 months after complete the treatment. corneometer,Melanin and erythema index Baseline, 1, 3, 6, 9 and 12 months after complete the treatment. mexameter,ITA index Baseline, 1, 3, 6, 9 and 12 months after complete the treatment. colorimeter,Sebum Baseline, 1, 3, 6, 9 and 12 months after complete the treatment. sebum meter,Physician improvement scale Baseline, 1, 3, 6, 9 and 12 months after complete the treatment. Quartile scale,Patient improvement scale Baseline, 1, 3, 6, 9 and 12 months after complete the treatment. Quartile scale,Pain score Immediate Visual analog scale ,Safety Immediate, 1, 3, 6, 9 and 12 months after complete the treatment. Adverse event | — |
Countries
Thailand
Contacts
Faculty of Medicine Siriraj Hospital, Mahidol University