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The study to evaluate the efficacy and safety of Bipolar Radiofrequency-Assisted Lipolysis combined with Adjustable-depth fractional microneedle bipolar radiofrequency for periorbital Rejuvenation

The study to evaluate the efficacy and safety of Bipolar Radiofrequency-Assisted Lipolysis combined with Adjustable-depth fractional microneedle bipolar radiofrequency for periorbital Rejuvenation

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230417001
Enrollment
38
Registered
2023-04-17
Start date
2023-03-30
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Patient Bipolar Radiofrequency-Assisted Lipolysis,Adjustable-depth fractional microneedle bipolar radiofrequency,periorbital Rejuvenation

Interventions

Patients were treated with Accutite and Morpheus8 for 1 session then they were instructed to follow up at 1 month, 3 months, 6 months after the last treatments.
Experimental Device
Accutite and morpheus8

Sponsors

ASTRACO MEDICAL NETWORKS LTD.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 30-65 years 2. Both male and Female 3.Tear trough with mild to moderate skin laxity at eye

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Volume change Baseline, 1 month,3 months, 6 months Vectra

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactThanya Techapichetvanich

Faculty of Medicine Siriraj Hospital, Mahidol University

thanya.tec@gmail.com66837122248

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026