laxity, enlarged pore laxity, enlarged pore
Conditions
Interventions
Each participants was treated with 2 sessions using 6.78 MHz Monopolar Radiofrequency with one-month interval
- 1st session: tip 4 cm2, energy level 2.5-3, 3-4 passes, overlapping 15-30%, total 300 sh
Experimental Device
A 6.78 MHz Monopolar Radiofrequency
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. Presence of visibly enlarged pores on both cheeks and the nose, as observed with the naked eye. The principal investigator must confirm the presence of clinically significant enlarged pores. 3. Mild to moderate facial skin laxity, corresponding to grade 1 to 2.5 on the Skin Laxity Grading Scale (as shown in the reference table). 4. Thai of Asian descent. 5. Willing to voluntarily participate in the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant participants, those who are within 1 year postpartum, or currently breastfeeding. 2. Participants who have not signed written informed consent to voluntarily participate in the study. 3. Participants who have undergone thread lifting, energy-based facial lifting procedures, or facial surgery within 12 months prior to study participation. 4. Participants with a history of dermal filler injection, botulinum toxin injection, or collagen-stimulating agent injection within 6 months prior to study participation. 5. Participants with a history of Cushing syndrome or Ehlers Danlos syndrome. 6. Participants who are currently taking oral isotretinoin. 7. Participants who have cancer, are undergoing cancer treatment, or have a history of skin cancer in the treatment area. 8. Participants with serious underlying diseases, or those with cardiac pacemakers or metal implants in the facial area. 9. Participants with a history of immunodeficiency, including those with HIV infection or AIDS. 10. Participants with a history of hypertrophic scars or skin rashes in the treatment area. 11. Participants with open wounds or active skin infections in the treatment area. 12. Participants with a history of herpes simplex infection or active herpes lesions. 13. Participants with a history of psychiatric disorders. 14. Participants with any medical or physical condition that, in the opinion of the investigators, may pose a safety risk during participation in the study. 15. Participants who do not consent to photography for treatment evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pores Baseline, 1 month after 1st treatment1, 3 and 6 months after 2nd treatment Antera3D,Volumetric changes Baseline, 1 month after 1st treatment1, 3 and 6 months after 2nd treatment Quantificare | — |
Secondary
| Measure | Time frame |
|---|---|
| Physician improvement scale 1 month after 1st treatment1, 3 and 6 months after 2nd treatment Quartile scale,Patient improvement scale 1 month after 1st treatment1, 3 and 6 months after 2nd treatment Quartile scale,Safety Baseline, 1 month after 1st treatment1, 3 and 6 months after 2nd treatment Adverse event | — |
Countries
Thailand
Contacts
Public ContactRungsima Wanitphakdeedecha
Department of Dermatology, Faculty of medicine Siriraj hospital, Mahidol university
Outcome results
None listed