Periorbital and Perioral Wrinkles
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: >=35 and <=55 years old, no gender restriction; 2. Fitzpatrick skin phototype II–IV; 3. Periorbital and perioral wrinkles scored 3–6 points on the Fitzpatrick wrinkle grading scale as assessed by blinded investigators; 4. Subjects voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with hypersensitivity to near-infrared light; 2. Subjects with recent excessive sun exposure or anticipated unavoidable sun exposure after treatment; 3. Subjects who have undergone lower eyelid surgery (including blepharoplasty, periorbital lifting, etc.) within 1 year prior to enrollment; 4. Subjects receiving intradermal mesotherapy (e.g., sodium hyaluronate, collagen, autologous fat), botulinum toxin injection, thread lifting or other relevant treatments on periorbital and perioral areas within 6 months prior to enrollment; 5. Subjects planning to receive any facial aesthetic procedures during the trial period; 6. Subjects with bacterial, fungal, viral or other cutaneous infections at target treatment sites; 7. Subjects with malignant tumors or undiagnosed cutaneous lesions in the intended treatment areas; 8. Subjects with open wounds within the intended treatment areas; 9. Subjects with concomitant skin disorders interfering with wrinkle assessment in target areas, including melasma, post-inflammatory hyperpigmentation, acne, perioral dermatitis, granuloma, eczema, verruca plana, lichen planus, etc.; 10. Subjects with abnormal coagulation tests, history of coagulation disorders, or ongoing anticoagulant medication; 11. Subjects implanted with cardiac pacemakers or defibrillators; 12. Subjects with severe systemic diseases involving heart, brain, liver, kidney, lung or hematological system, autoimmune diseases, immunodeficiency diseases, or systemic muscular movement disorders; 13. Subjects with a medical history of photosensitive epilepsy; 14. Subjects with past medical history of squamous cell carcinoma or melanoma; 15. Subjects with keloid diathesis/scar diathesis; 16. Subjects undergoing chemotherapy or radiotherapy; 17. Subjects with psychiatric disorders or unstable emotional status; 18. Pregnant, lactating women and females attempting conception; 19. Other subjects deemed inappropriate for study enrollment by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fitzpatrick wrinkle score; | — |
Secondary
| Measure | Time frame |
|---|---|
| GAIS grading and global aesthetic effect response rate; | — |
Countries
China
Contacts
Department of Dermatology, West China Hospital, Sichuan University.