facial rejuvenation
Conditions
Interventions
Experimental group:Full-face injection of Sodium Hyaluronate Complex Solution produced by Zhu Yan Legend (Xiamen) Biotechnology Co., Ltd.
control group:Full-face injection of Sodium Hyaluronate Complex Solution produced by Bloomage Biotech Co., Ltd.
Sponsors
Department of Dermatology, Beijing Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years inclusive (both inclusive); 2. Individuals seeking temporary improvement in facial skin dryness, dull complexion, and skin elasticity; 3. Skin Fitzpatrick type II–IV; 4. Participants agreeing not to undergo other cosmetic treatments related to the study during the trial period; 5. Voluntary participation in this trial and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Within the 12 months preceding the screening date, having received injections in the facial region of hydroxyapatite calcium (CaHA), poly-L-lactic acid (PLLA), polycaprolactone (PCL), collagen fillers, cross-linked sodium hyaluronate gel, botulinum toxin, or autologous fat; or within the preceding 3 months, received mesotherapy (e.g., hydrating injections, microneedling), non-crosslinked hyaluronic acid treatments, or plans to undergo such treatments during study participation; 2. Within the preceding 3 months of the screening date, received photorejuvenation or chemical peels in the facial area, or plans to undergo such treatments during study participation; 3. Undergone facial skin treatments within 6 months prior to the screening date (e.g., non-invasive energy or radiofrequency therapies (e.g., Ultherapy, Thermage, etc.), lipolysis treatments (e.g., deoxycholic acid injections, cryolipolysis, etc.)), or plans to undergo such treatments during study participation; 4. Individuals who have undergone permanent (e.g., polyacrylamide gel (PAAG), hydroxyethyl methacrylate, etc.) and/or semi-permanent dermal filler treatments (e.g., polymethyl methacrylate (PMMA), etc.) in the facial area, or who plan to undergo such treatments during the study period; 5. Individuals who have undergone facial cosmetic surgery (e.g., facelift, thread lift) within the 12 months preceding the screening date, or who plan to undergo such procedures during study participation; 6. Individuals with permanent implants (e.g., silicone, polytetrafluoroethylene), grafts, or unidentified injectables in the facial injection area that may interfere with efficacy assessment; 7. Individuals with acute or progressive dermatological conditions at the injection site (e.g., recurrent herpes simplex, active acne, acute eczema, contact dermatitis, acute atopic dermatitis, inflammatory conditions such as psoriasis, vitiligo, etc.); 8. Presence of cutaneous granulomas; 9. Malignant tumours or skin masses of unknown nature on the face; 10. Facial nerve palsy or history thereof; 11. History or documented evidence of autoimmune or rheumatic diseases (e.g., scleroderma, lupus erythematosus, rheumatoid arthritis); 12. Presence of keloids, hypertrophic scars, or keloid-prone skin (e.g., history of keloid formation); 13. Known bleeding disorders, or receipt or planned receipt within 14 days prior to screening date of anticoagulants, antiplatelet agents, thrombolytics (e.g., phenprocoumon, warfarin, heparin, clopidogrel), non-steroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen, diclofenac), or other medications known to prolong clotting time; 14. Individuals with renal impairment (serum creatinine or blood urea nitrogen exceeding 1.5 times the upper limit of normal); or hepatic dysfunction (AST or ALT exceeding 2.5 times the upper limit of normal); 15. Uncontrolled diabetes (fasting or pre-meal blood glucose exceeding 8 mmol/L, or postprandial blood glucose exceeding 12 mmol/L); 16. History of severe or multiple allergies, hypersensitivity to any component of the investigational product, or use of immunosuppressive agents; 17. Currently undergoing chemotherapy/radiotherapy; 18. Psychological disorders or psychiatric conditions; 19. Individuals requiring prolonged outdoor work or sun exposure post-surgery; 20. Women who are pregnant, breastfeeding, or planning pregnancy during the trial period; 21. Individuals undergoing systemic hormone therapy; 22. Participants who have taken p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Aesthetic Improvement Scale (GAIS) Improvement Rate;Improvement Rate on the Comprehensive Scale for Transient Alleviation of Skin Dryness and Dullness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Global Aesthetic Improvement Scale (GAIS) Improvement Rate;Improvement rates of subject self-assessed GAIS scores before the 2nd injection, before the 3rd injection, and at weeks 4, 8, and 12 after the last injection;Change from baseline in skin moisture content;Improvement rates in skin dryness;Improvement rates in skin dullness;Change from baseline in skin elasticity;Subject Satisfaction Scores;VAS Scores for Pain Intensity Assessed; | — |
Countries
China
Contacts
Public ContactWei Xu
Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed