facial laxity laxity
Conditions
Interventions
Each participants will be treated with dual-frequency 2 and 6.78 MHz noninvasive monopolar radiofrequency
Then instructed to follow-up at the time points of 1,2,3 and 6 months after treatment
Experimental Device
dual frequency 2 and 6.78 MHz noninvasive monopolar radiofrequency
Sponsors
Faculty of Medicine Siriraj hospital
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age between 40 to 60 years 2. BMI less than 30 3. Ethnically Thai of Asian descent 4. Presenting with mild to moderate facial skin laxity and willing to undergo treatment using a dual frequency monopolar radiofrequency device
Exclusion criteria
Exclusion criteria: 1. Pregnant women or currently breastfeeding, or within 3 months postpartum. 2. Individuals with implanted cardiac pacemakers. 3. History of treatment involving laser, radiofrequency, thread lifting, or other facial/neck skin-tightening procedures within the past 6 months. 4. History of chemical peels on the face or neck within the past 6 months. 5. History of botulinum toxin injection in the face or neck within the past 6 months. 6. History of dermal filler injections or platelet-rich plasma (PRP) injections on the face or neck within the past 6 months. 7. Use of oral isotretinoin or topical retinoids within the past 6 months. 8. Presence of other dermatologic conditions, previous radiation therapy, or active skin infection in the treatment area. 9. History of medical conditions such as: Platelet disorders, Coagulopathies, Anemia, Liver disease, Cancer, Autoimmune disorders, Diabetes mellitus or any condition deemed unsafe for participation by the investigators (e.g., epilepsy) 10. Current smoker or history of heavy alcohol consumption, defined as: 11. Smoking history of at least 30 pack-years 12. Alcohol intake of more than 2 standard drinks per day or more than 5 days per week 1 standard drink = 10 g alcohol 13. History of hypertrophic scars or keloids. 14. Failure to provide written informed consent to participate in the study. 15. Refusal to allow photography for treatment evaluation purposes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volumetric changes Baseline, 1,2,3 and 6 months after treatment Measured by 3D camera LifeViz digital imaging system (QuantifiCare S.A., Valbonne, France),Cutometry (skin firmness/pliability and skin elasticity) 1,2,3 and 6 months after treatment Cutometer,wrinkles 1,2,3 and 6 months after treatment Antera 3D,Physician improvement scale 1,2,3 and 6 months after treatment Quartile scale,Safety 1,2,3 and 6 months after treatment Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| texture 1,2,3 and 6 months after treatment Antera 3D,pores 1,2,3 and 6 months after treatment Antera 3D,melanin and erythema index 1,2,3 and 6 months after treatment Mexameter,ITA 1,2,3 and 6 months after treatment Colorimeter,skin hydration 1,2,3 and 6 months after treatment Corneometer,Sebum level 1,2,3 and 6 months after treatment sebumeter,Participants improvement scale 1,2,3 and 6 months after treatment Quartile scale,Pain score Treatment visit Visual analog scale | — |
Countries
Thailand
Contacts
Public ContactWoraphong Manuskiatti
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed