Effectiveness and safety of hands-free bipolar radiofrequency device in submental fat reductio
Phase 1
Completed
- Conditions
- Effectiveness and safety of hands-free bipolar radiofrequency device in in patients with submittal fat Grade 2-4Bipolar radiofrequency, Submental fat, Skin aging
- Registration Number
- TCTR20230124002
- Lead Sponsor
- Institute of dermatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1. Both male and female subjects
2. BMI < 30
3. Patient with sagging and wrinkle skin on submental area4. submental fat Grade 2-4 by Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
Exclusion Criteria
1. Pregnancy women
2. Patient with photosensitivity
3. Patient with history of keloid and skin infection on submental fat area
4. Using cardiac PACE maker or antiplatelet
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method submental fat volume depletion at the last 4th treatment and 4 week , 8 week after final session 3D camera VECTRA and compared by computer program
- Secondary Outcome Measures
Name Time Method Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) at baseline and each post treatment and 4 week , 8 week after final session 3D camera VECTRA and compared by computer program,Global aesthetic improvement scale (GAIS) at the last 4th treatment and 4 week , 8 week after final session by 3 blinded investigator ,Patient satisfaction score (PSS) at each post treatment and and 4 week , 8 week after final session evaluated by patient