Patients with mid to moderate facial laxity facial laxity facial contour Polycaprolactone (PCL) filler neocollagenesis
Conditions
Interventions
Patients will be treated with 2.4 mL of PCL filler administered at 10 predetermined injection points on the face. Follow-up visits will be scheduled at 1, 3, 6, 9, and 12 months after treatment.
Experimental Drug
PCL filler
Sponsors
Rungsima Wanitphakdeedecha
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 30-60 2. moderate-severe photoaging 3. mild-moderate facial laxity
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women 2. patients with history of platelet disorders, coagulation abnormalities, anemia, liver disease, cancer, or autoimmune disorders. 3. Patients who smoke or have a history of excessive alcohol consumption (defined as a smoking history of more than 20 pack-years and alcohol consumption exceeding 15 standard drinks per week for men or 8 standard drinks per week for women). 4. Patients with facial dermatitis, wounds, or skin infections at the treatment site. 5. Patients with a history of allergy to local anesthetic agents. 6. Patients who currently taking medications that affect blood coagulation, such as aspirin or anticoagulants. 7. Individuals who have undergone laser treatment, radiofrequency treatment, thread lifting, or other facial tightening procedures within 6 months prior to study enrollment. 8. Individuals who have undergone facial chemical peeling within 6 months prior to study enrollment. 9. Individuals who have received botulinum toxin injections to the face within 6 months prior to study enrollment. 10. Patients who have received dermal filler injections or platelet-rich plasma (PRP) injections to the face within 6 months prior to study enrollment. 11. Patients with a history of hypertrophic scar or keloid formation. 12. Patients with psychiatric disorders previously diagnosed by a psychiatrist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average Wrinkle and Texture baseline, 1, 3, 6, 9, 12 months after treatment Antera,Physician improvement scale baseline, 1, 3, 6, 9, 12 months after treatment Quantile scale,volume change baseline, 1, 3, 6, 9, 12 months after treatment Quantificare LifeViz | — |
Secondary
| Measure | Time frame |
|---|---|
| skin firmness baseline, 1, 3, 6, 9, 12 months after treatment Cutometer,Melanin pigment, erythema baseline, 1, 3, 6, 9, 12 months after treatment Mexameter,skin hydration baseline, 1, 3, 6, 9, 12 months after treatment Corneometer,skin brightness baseline, 1, 3, 6, 9, 12 months after treatment Colorimeter,sebum level baseline, 1, 3, 6, 9, 12 months after treatment Sebumeter,Physician improvement scale baseline, 1, 3, 6, 9, 12 months after treatment Quantile scale,Pain score immediate after treatment Visual analog scale | — |
Countries
Thailand
Contacts
Public ContactRungsima Wanitphakdeedecha
Affiliation : Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed