Infraorbital hollows
Conditions
Interventions
Treatment Group:The experimental group will receive treatment on Day 0. A touch-up injection may be administered 1 month after the initial injection. Subjects will return to the research center for ef
Control group:The control group will not receive treatment on Day 0. Efficacy and safety assessments will be conducted 3 months after randomization. After completing the follow-up, subjects may receiv
Sponsors
Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years (inclusive), male or female. 2. Subjects who intend to treat moderate to severe infraorbital hollows. 3. The blinded investigator assesses that the subject has bilateral moderate or severe infraorbital hollows (Grade 2-3) according to the AIHS assessment (both sides must meet the criteria but are not required to have the same score). 4. Voluntarily sign the informed consent form, understand and accept the study duration, and are able and willing to comply with all requirements, including scheduled treatments, follow-ups, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Known history of severe allergic reactions or anaphylaxis; or allergy to any component of the test product. 2. Currently or previously suffering from uncontrolled retinal diseases (e.g., retinal detachment) or any other diseases that may lead to vision loss (e.g., uncontrolled diabetes), diseases causing increased intraocular pressure (e.g., glaucoma), facial spasm, or exophthalmos (e.g., caused by hyperthyroidism). 3. Presence of active or recurrent infection in either eye. 4. Participation or current participation in a drug clinical trial within 3 months, or participation or current participation in another medical device clinical trial within 1 month. 5. Abnormal coagulation (APTT >1.5 times the upper limit of normal) during the screening period deemed clinically significant by the investigator, or use of any thrombolytic, anticoagulant, or antiplatelet drugs (e.g., warfarin, aspirin, clopidogrel) within 2 weeks prior to enrollment. 6. Severe dysfunction of major organs (brain, heart, lungs, liver, kidneys, etc.) as judged by the investigator, such as severe cardiovascular/cerebrovascular diseases (hospitalization for myocardial infarction or cardiac surgery within 3 months, history of congestive heart failure or myocardial infarction, severe unstable arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysm, stroke, etc.), severe pulmonary diseases (moderate to severe pneumonia, respiratory failure, etc.), uncontrolled diabetes, or epilepsy. 7. Active autoimmune disease (e.g., inflammatory bowel disease) or history thereof, active connective tissue disease (e.g., rheumatoid arthritis, scleroderma, systemic lupus erythematosus) or history thereof, or subjects receiving immunomodulatory therapy. 8. Having received chemotherapy, immunomodulatory therapy (e.g., immunosuppressants, monoclonal antibodies, etc.), or systemic corticosteroid therapy (excluding inhaled corticosteroids) within 3 months prior to enrollment. 9. Women who are pregnant or breastfeeding, planning to become pregnant during the trial, or women of childbearing potential not using medically effective contraceptive methods. 10. Male subjects planning for pregnancy or unwilling to use appropriate contraception. 11. Presence of tattoos, deformities, scars, unhealed wounds, active skin diseases or infections/inflammation (e.g., eczema, acne, dermatitis, psoriasis, herpes, etc.), cancerous or precancerous lesions, etc., in the area to be treated that may affect efficacy evaluation or increase treatment risk. 12. Subjects with excessive pigmentation in the infraorbital region (excluding dark circles not caused by hyperpigmentation). 13. Previous treatment in the infraorbital or periorbital area with permanent fillers (e.g., polymethyl methacrylate, silicone, etc.) or semi-permanent fillers (e.g., calcium hydroxylapatite, poly-L-lactic acid, polycaprolactone, etc.), autologous fat, etc., within 24 months prior to screening, or planning to receive such treatments during the clinical trial. 14. Previous use of cross-linked sodium hyaluronate or collagen injections or other temporary fillers in the infraorbital area within 12 months, or non-cross-linked sodium hyaluronate or collagen injections in the infraorbital area within 3 months prior to enrollment. 15. Having undergone or planning to undergo cosmetic procedures in the infraorbital injection area or periorbital region within the preceding 6 months or during the study period that may affect the judgment o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The response rate for improvement of infraorbital hollows at 3 months after the last injection.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blinded Investigator's Infraorbital Hollowing Scale Score;Volume Change in the Infraorbital Hollow Areas (Sum of Both Sides) Compared to Baseline as Analyzed by 3D Imaging System;Injecting Investigator's Infraorbital Hollowing Scale Score;Injecting Investigator’s Global Aesthetic Improvement Scale (GAIS) Score;Subject’s Global Aesthetic Improvement Scale (GAIS) Score;Subject Satisfaction;Numerical Rating Scale (NRS) Score; | — |
Countries
China
Contacts
Public ContactJufang Zhang
Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine
Outcome results
None listed