The study to evaluate the efficacy and safety of Bipolar Radiofrequency-Assisted Lipolysis combined with Adjustable-depth fractional microneedle bipolar radiofrequency for periorbital Rejuvenatio
- Conditions
- Healthy PatientBipolar Radiofrequency-Assisted Lipolysis,Adjustable-depth fractional microneedle bipolar radiofrequency,periorbital Rejuvenation
- Registration Number
- TCTR20230417001
- Lead Sponsor
- ASTRACO MEDICAL NETWORKS LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 38
1. Aged 30-65 years
2. Both male and Female
3.Tear trough with mild to moderate skin laxity at eye
1. Subjects who are pregnant or lactation
2. Subjects who had history of low platelet, coagulopathy, anemia, liver disease, cancer, immunocompromised host or epilepsy
3. Subjects who has dermatits, wound or infection at treatment area
4. Subjects who allergy to anesthesia cream
5. Subjects who taken oral or injection contraceptive pills or coagulopathy drug
6. Subjects who had history of botulinum toxin treatment within 12 months before arrived the project
7. Subjects who had history of laser at treatment area within 6 months before arrived the project 8. Subjects who had history of keloid or hypertrophic scar
9. Subjects who had history of psychitic disease
10. Subjects who had metalic equipment in the body
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Volume change Baseline, 1 month,3 months, 6 months Vectra
- Secondary Outcome Measures
Name Time Method Skin Texture and Wrinkle Baseline, 1 month,3 months, 6 months Antera,Skin elasticity Baseline, 1 month,3 months, 6 months Cutometer,Doctor Evaluation Baseline, 1 month,3 months, 6 months Quatile Scale,Patient Evaluation Baseline, 1 month,3 months, 6 months Quatile scale,Pain Score Baseline Visual Analog Scale,safety Baseline, 1 month,3 months, 6 months Adverse Effect