Skin Condition
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged between 18 and 65 years who are willing to receive Sodium Hyaluronate Solution for Injection treatment to improve skin condition; 2.Subjects with facial skin presenting one of the following conditions: dull skin tone, dryness, slightly reduced elasticity, or fine wrinkles; 3. Skin Fitzpatrick type II-IV; 4.Subjects who voluntarily agree to abstain from any other facial aesthetic treatments except the trial treatment during the study period, and refrain from using any other medical treatments not approved by the researchers; 5. Subjects are willing to take part in the test and sign Informed Consent Form;6. Subjects who are willing to adhere to their original skincare habits and the study guidelines, and complete all required follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Facial presence of obvious acne scars, active inflammation, infection, cancerous or precancerous lesions, or unhealed wounds; 2. Previous facial treatment with permanent (e.g., silicone, Artecoll®) or semi-permanent (e.g., fat, hydroxyapatite, polylactic acid) dermal fillers; 3. Treatment with short-acting dermal fillers (e.g., collagen, cross-linked sodium hyaluronate gel, platelet-rich plasma (PRP)) within 1 year prior to the study injection; 4. Previous facial surgery or other facial improvement surgeries before signing the informed consent form; 5. Previous various facial treatments in the target area within 6 months prior to the study injection, such as botulinum toxin injection, laser resurfacing, dermabrasion, chemical peeling; or non-invasive skin rejuvenation methods such as moderate to deep resurfacing, ultrasound, radiofrequency, or laser therapy; 6. Currently receiving immunosuppressive therapy; 7. Presence of other active skin diseases in the local area within the past 6 months, such as infection, local wounds, psoriasis, and herpes simplex; 8. Scar constitution (keloid or hypertrophic scar tendency); 9. Subjects with sunburned faces within the past month or those requiring long-term outdoor work; 10. History of severe diseases of major organs (e.g., cardiovascular system, liver, lungs, nervous system, kidneys) or history of immune dysfunction (e.g., autoimmune diseases, immunocompromised status); 11. History of bleeding tendency or current use of medications known to prolong coagulation time (e.g., aspirin, non-steroidal anti-inflammatory drugs, clopidogrel, warfarin) as part of other disease treatment regimens, and unwillingness or inability to discontinue these medications within 2 weeks before screening; 12. Pregnant or lactating women, or subjects planning to become pregnant during the trial period; 13. Plans to undergo any surgery or take any medications that may cause significant weight changes during the study period (e.g., systemic corticosteroids, weight-loss drugs, bariatric surgery); 14. Participation in any other clinical trials within 1 month before signing the informed consent form; 15. History of severe allergic reactions, allergy history to hyaluronic acid products, or severe allergic reactions to multiple substances,or evidence of severe atopy; 16. Subjects without full capacity for civil conduct; 17. Subjects deemed unsuitable for participation by the investigator, such as those at significant risk from trial participation, those who may confound study results, those with unrealistic expectations, or those with obvious psychological disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall cosmetic effect improvement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigators' assessment of the Global Aesthetic Improvement Scale;Subjects' assessment of the Global Aesthetic Improvement Scale;Investigators' assessment of the dull skin tone;Subjects' assessment of the dull skin tone;Subjects' satisfaction;Improvement in skin physiological indicators; | — |
Countries
China
Contacts
Department of Dermatology, Beijing Friendship Hospital, Capital Medical University