Patients with facial skin laxity. facial skin laxity, Micro Focused Ultrasound, Radio Frequency, microneedling
Conditions
Interventions
Patients will undergo a facial lifting and tightening procedure using the energy based device with Micro Focused Ultrasound (MFU) and Radio Frquency (RF). Then they were instructed to follow up at 1,
Active Comparator Device,Active Comparator Device
Micro Focused Ultrasound (MFU) and Radio Frquency (RF),Micro Focused Ultrasound (MFU), Radio Frquency (RF) and microneedling RF
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 40 and 60 years, both male and female. 2. Body Mass Index (BMI) less than 30 3. Thai nationals of Asian ethnicity. 4. Evaluated by a dermatologist and determined to have at least a moderate degree of photoaging according to the Glogau Classification of Photoaging. 5. Presence of mild to moderate facial skin laxity.
Exclusion criteria
Exclusion criteria: 1. Volunteers who are pregnant or breastfeeding. 2. Volunteers with an implanted cardiac pacemaker. 3. Volunteers with a history of receiving laser treatment botulinum toxin injections radiofrequency therapy ultrasound therapy thread lifting dermal filler injections collagen biostimulator injections platelet rich plasma injections chemical peeling or other facial tightening procedures within 6 months prior to enrollment in the study. 4. Volunteers who have used topical retinoids within 3 months prior to enrollment in the study. 5. Volunteers with active dermatitis open wounds a history of hypertrophic scarring skin cancer in the treatment area or active skin infection in the treatment area. 6. Volunteers with a history of platelet disorders coagulation disorders autoimmune diseases immunodeficiency HIV or AIDS or other conditions deemed by the investigators to pose potential safety risks for study participation such as epilepsy. 7. Volunteers with a history of bleeding disorders or those currently taking medications that affect blood coagulation such as aspirin or anticoagulants. 8. Volunteers with a history of allergy to topical anesthetic agents. 9. Volunteers with a history of psychiatric disorders. 10. Volunteers who smoke or have a history of heavy alcohol consumption defined as smoking history of 30 pack years or more or alcohol intake more than 2 standard drinks per day or more than 5 days per week where one standard drink equals 10 grams of alcohol equivalent to one can of beer with alcohol content 5 to 7 percent three caps of spirits with alcohol content 40 to 43 percent or one glass of wine with alcohol content 11 to 13 percent. 11. Volunteers with a history of hypertrophic scars or keloids. 12. Volunteers who have not provided written informed consent to participate in the study. 13. Volunteers who do not permit photography for treatment outcome assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physician improvement scale Baseline, 1 month after treatment, 3 months after treatment, 6 months after treatment Quartile scale,Wrinkle improvement Baseline, 1 month after treatment, 3 months after treatment, 6 months after treatment Antera 3D,Lifting improvement Baseline, 1 month after treatment, 3 months after treatment, 6 months after treatment Quantificare,Volume analysis Baseline, 1 month after treatment, 3 months after treatment, 6 months after treatment Vectra,Skin elasticity Baseline, 1 month after treatment, 3 months after treatment, 6 months after treatment Cutometer | — |
Secondary
| Measure | Time frame |
|---|---|
| Texture and pore improvement Baseline, 1 month after treatment, 3 months after treatment, 6 months after treatment Antera 3D,Pain score Baseline, 1 month after treatment, 3 months after treatment, 6 months after treatment Visual analog scale,Safety Baseline, 1 month after treatment, 3 months after treatment, 6 months after treatment Adverse event | — |
Countries
Thailand
Contacts
Public ContactYanin Nokdhes
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed