Patients with facial laxity monopolar radiofrequency, lower face, skin tightening
Conditions
Interventions
Each participant will undergo one session of monopolar radiofrequency treatment on the upper face according to the following protocol.
Cheek: Energy level 2.5 to 10, 50 to 100 J/shot, 100 shots/each
Experimental Device
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
35 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age 35 - 60 years old both male and female 2. BMI less than 30 kg/m2 3. Patients with mild to moderate facial laxity, classified according to the grading scale as shown.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding 2. Participants with an implanted cardiac pacemaker. 3. Participants with a history of laser treatment, radiofrequency treatment, thread lifting, or other facial tightening procedures within 6 months prior to study enrollment. 4. Participants with a history of chemical peeling of the facial area within 6 months prior to study enrollment. 5. Participants with a history of botulinum toxin injection to the face within 6 months prior to study enrollment. 6. Participants with a history of facial filler injection or platelet-rich plasma (PRP) injection to the face within 6 months prior to study enrollment. 7. Participants who have used isotretinoin or topical retinoids within 6 months prior to study enrollment. 8. Participants with other dermatologic diseases, a history of radiotherapy, or active skin infection in the treatment area. 9. Participants with a history of platelet disorders, coagulation disorders, anemia, liver disease, malignancy, autoimmune disease, diabetes mellitus, or any condition deemed by the investigator to pose a potential safety risk, such as epilepsy. 10. Participants who smoke or have a history of heavy alcohol 11. Participants with a history of hypertrophic scarring or keloid formation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lifting effect Baseline, 4,8,12,24,36,46 weeks follow up Quantificare,Texture Baseline, 4,8,12,24,36,46 weeks follow up Antera,Pigmentation Baseline, 4,8,12,24,36,46 weeks follow up Antera,Erythema Baseline, 4,8,12,24,36,46 weeks follow up Antera,Wrinkle Baseline, 4,8,12,24,36,46 weeks follow up Antera,Fine lines Baseline, 4,8,12,24,36,46 weeks follow up Antera,Folds Baseline, 4,8,12,24,36,46 weeks follow up Antera,Mean Pore Area Baseline, 4,8,12,24,36,46 weeks follow up Antera,Baseline, 4,8,12,24,36,46 weeks follow up Baseline, 4,8,12,24,36,46 weeks follow up Antera,Volume Depression Baseline, 4,8,12,24,36,46 weeks follow up Antera,Skin elasticity Baseline, 4,8,12,24,36,46 weeks follow up Cutometer,Melanin index Baseline, 4,8,12,24,36,46 weeks follow up Mexameter,Erythema index Baseline, 4,8,12,24,36,46 weeks follow up Mexameter,Hydration Baseline, 4,8,12,24,36,46 weeks follow up corneometer,ITA Baseline, 4,8,12,24,36,46 weeks follow up colorimeter,Sebum level Baseline, 4,8,12,24,36,46 weeks follow up Sebumeter | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Improvement scale Baseline, 4,8,12,24,36,46 weeks follow up percent improvement,Physician Improvement scale Baseline, 4,8,12,24,36,46 weeks follow up percent improvement,Safety Baseline, 4,8,12,24,36,46 weeks follow up Adverse event,Pain score Treatment visit Visual analog scale | — |
Countries
Thailand
Contacts
Public ContactRungsima Wanitphakdeedecha
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed