laxity laxity
Conditions
Interventions
Each participant will receive four treatment sessions, performed once weekly, using synchronized RF and HIFES delivered through adhesive pads applied to the periorbital region. Each session will last
Experimental Device
synchronized radiofrequency (RF) and high-intensity focused electric stimulation (HIFES)
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Participants aged 40 to 60 years, male or female. 2. Participants with visible under-eye skin laxity. 3. Participants of Thai or Asian ethnicity. 4. Participants who voluntarily consent to participate in the study and agree to standardized photography as part of the treatment and assessment process.
Exclusion criteria
Exclusion criteria: 1. Participants with a cardiac pacemaker. 2. Participants wearing orthodontic braces. 3. Participants with metal implants or prosthetic devices within the body. 4. Pregnant or breastfeeding participants. 5. Participants with a history of hematologic disorders, coagulation abnormalities, anemia, liver disease, cancer, or autoimmune disorders. 6. Participants who smoke or have a history of heavy alcohol consumption. 7. Participants with dermatitis, wounds, or active skin infections on the face. 8. Participants taking anticoagulants or other blood-thinning medications (e.g., aspirin). 9. Participants who have undergone facial tightening treatments (e.g., energy-based lifting devices or thread lifting) within 6 months prior to enrollment. 10. Participants who have received dermal filler injections on the face within 6 months prior to enrollment. 11. Participants who have received platelet-rich plasma (PRP) injections on the face within 6 months prior to enrollment. 12. Participants who have received botulinum toxin injections on the face within 6 months prior to enrollment. 13. Participants who have undergone collagen-stimulating laser treatments on the face, such as picosecond laser, Er:YAG laser, Fractora, or E-matrix laser, within 6 months prior to enrollment. 14. Participants with a history of hypertrophic scars or keloids. 15. Participants with a psychiatric disorder diagnosed by a psychiatrist. 16. Participants who do not permit photography for treatment evaluation. 17. Participants with ocular muscle disorders or pre-existing eye diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| under eye volume change compared to baseline before the third treatment, and at 1, 3, and 6 months following the final (fourth) treatment. Quantificare LifeViz | — |
Secondary
| Measure | Time frame |
|---|---|
| wrinkles baseline, before the third treatment, and at 1, 3, and 6 months following the final (fourth) treatment. Antera3D,Texture baseline, before the third treatment, and at 1, 3, and 6 months following the final (fourth) treatment. Antera3D,skin firmness/elasticity baseline, before the third treatment, and at 1, 3, and 6 months following the final (fourth) treatment. Cutometer,Melanin index baseline, before the third treatment, and at 1, 3, and 6 months following the final (fourth) treatment. Mexameter,Erythema index baseline, before the third treatment, and at 1, 3, and 6 months following the final (fourth) treatment. Mexameter,Physician assessment before the third treatment, and at 1, 3, and 6 months following the final (fourth) treatment. Quartile scale,Patients improvement scale before the third treatment, and at 1, 3, and 6 months following the final (fourth) treatment. Quartile scale,Safety baseline, before the third treatment, and at 1, 3, and 6 months following the final (fourth) treatment. Adverse events,Pain score During each treatment Visual analog scale | — |
Countries
Thailand
Contacts
Public ContactWoraphong Manuskiatti
Department of Dermatology, Faculty of medicine Siriraj hospital, Mahidol university
Outcome results
None listed