Periorbital wrinkle Periorbital skin aging Periorbital skin rejuvenation Microneedle radiofrequency
Conditions
Interventions
Virtue radiofrequency (RF) microneedling platform designed for tissue tightening, scar revision, and overall skin rejuvenation. It combines mechanical microneedling with targeted RF energy delivered d
Experimental Device,Active Comparator Device
Virtue Radiofrequency Microneedling,Ultherapy
Sponsors
Laser Engineer Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 years or older 2. In good general health with no serious underlying medical conditions 3. Exhibits a similar degree of skin aging around both eyes 4. No active skin inflammation or infection on the face 5. Able to attend scheduled appointments and comply with all study requirements 6. Willing to participate in the study and provide signed informed consent
Exclusion criteria
Exclusion criteria: 1. Underlying medical conditions that affect inflammatory or wound healing processes, such as psoriasis, vitiligo, diabetes , Systemic Lupus Erythematosus (SLE), chronic kidney disease (stage 4 or higher), etc 2. Underlying medical conditions that cause abnormal skin pigmentation, such as Addison disease, hemochromatosis, etc 3. Immunocompromised states, such as bone marrow failure, or taking more than 15 mg/day of prednisolone, etc 4. History of skin cancer 5. Active skin infection or inflammation in the intended treatment area 6. Wounds or open sores on the face in the intended treatment area 7. Presence of more than 5 inflammatory acne lesions on both sides of the face 8. History of keloid scarring 9. Pregnant or currently breastfeeding 10. History of allergy to local anesthetics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrinkle baseline and at 1,2,3 month after the treatment Anthera 3D machine | — |
Secondary
| Measure | Time frame |
|---|---|
| Static wrinkle baseline and at 1,2,3 month after the treatment Merz aesthetic scales for evaluation of crow feet at rest (MAS),global aesthetic improvement score (GAIS) baseline and at 1,2,3 month after the treatment global aesthetic improvement score (GAIS),Texture baseline and at 1,2,3 month after the treatment Anthera 3D machine,Patient sastisfaction baseline and at 1,2,3 month after the treatment Visual analog scale | — |
Countries
Thailand
Contacts
Public ContactChinathip Theerawattanawit
Division of Dermatology, Department of Medicine Faculty of Medicine, Ramathibodi Hospital
Outcome results
None listed