The study to evaluate the efficacy and safety of Bipolar Radiofrequency-Assisted Lipolysis for Facial Contouring
Phase 4
Recruiting
- Conditions
- Healthy patientBipolar Radiofrequency-Assisted Lipolysis, Facial Contouring
- Registration Number
- TCTR20230516008
- Lead Sponsor
- ASTRACO MEDICAL NETWORKS LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
1. Aged 25-60 years
2. Both men and women
3. mild to moderate wrinkle
4. BMI 18-29.9
Exclusion Criteria
1. Pregnancy or lactation
2. Subject with underlying disease of coagulopathy, platelet dysfunction, cancer, immunocompromised host, epilepsy or psychiatric disease
3. Subject with cardiac pacemaker or metal equipment in body
4. current smoking or heavy alcoholism
5. Dermatitis or infection at face
6. History of anesthesia drug allergy
7. History of taking coagulopathy drug
8. History of isotretinoin or energy based deviced in 6 month before joining the research
9. History of botulinum toxin injection, filler in 12 month before joining the research
10. History of keloid
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Volume change Baseline, 1 month,3 months, 6 months,12 months Vectra
- Secondary Outcome Measures
Name Time Method BMI Baseline, 1 month,3 months, 6 months,12 months body weight,Doctor Evaluation Baseline, 1 month,3 months, 6 months,12 months Quatile Scale,Patient Evaluation Baseline, 1 month,3 months, 6 months,12 months Quatile scale,Pain Score Baseline, 1 month,3 months, 6 months,12 months Visual Analog Scale,safety Baseline, 1 month,3 months, 6 months,12 months Adverse Effect