The study to evaluate the efficacy and safety of Adjustable-depth fractional microneedle bipolar radiofrequency in Treatment of Wrinkle and Neck Contouring
Phase 4
Recruiting
- Conditions
- Healthy PatientAdjustable-depth fractional microneedle bipolar radiofrequency,Wrinkle and Neck Contouring
- Registration Number
- TCTR20230403002
- Lead Sponsor
- ASTRACO MEDICAL NETWORKS LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
1. Aged 25-55 years
2. Both male and Female
3.mild to moderate skin laxity
Exclusion Criteria
1. Subjects who are pregnant 2. Subjects who had history of low platelet, coagulopathy or taking medicine of antocoagulant drug like warfarin 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 6. Subjects who had history of melasma treatment within 6 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
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,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, 1 month,3 months, 6 months Visual Analog Scale,safety Baseline, 1 month,3 months, 6 months Adverse Effect