Temporary improvement for dry skin and dull complexion in adults
Conditions
Interventions
Experimental group:The experimental group received treatment with the experimental medical device (sodium hyaluronate composite solution for injection) three times (with
Untreated control group:No intervention
Sponsors
West China Hospital of Stomatology, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range of 18-65 years old (including 18 and 65 years old), gender is not limited; 2. Skin Fitzpatrick classification is II-IV type; 3. According to the researcher's judgment, the comprehensive facial skin condition score of the subjects should be at least one score = 2 points; 1.Inclusion criteria 4 Those who have a temporary need to improve facial dryness and dullness; 5. Participants who agree not to use other cosmetic treatments related to the study during the research period; 6. Voluntarily sign an informed consent form, understand and accept the duration of the study, and be able and willing to comply with all requirements, including treatment, follow-up, and other research procedures as planned.
Exclusion criteria
Exclusion criteria: 1.Known to be allergic to hyaluronic acid products or any ingredients in this product, allergic to any local anesthetic drugs (excluding standard lidocaine or other amide anesthetics), or in the acute phase of hypersensitivity reactions; 2. Facial skin infections (viral, fungal, bacterial); 2 Clinical trial plan for injection of sodium hyaluronate composite solution 3 Patients with facial skin granulomas; 4. Individuals with a history of scar hyperplasia or keloids in the past; 5. Individuals with active autoimmune diseases or a history of such diseases (such as systemic lupus erythematosus, rheumatoid arthritis, scleroderma, dermatomyositis, etc.); 6. Patients with active or progressive skin diseases or those with homologous reactions in the treatment area (such as acute eczema, flat warts, lichen planus, psoriasis vulgaris, acne, contact dermatitis, atopic dermatitis, herpes simplex, shingles, vitiligo, etc.); 7. Individuals with abnormal coagulation mechanisms during the screening period (activated partial thromboplastin time (APTT)>1.5 times the upper limit of normal (ULN)), or those who have received any thrombolytic, anticoagulant, or antiplatelet drugs (such as warfarin, aspirin, heparin, etc.) within 2 weeks prior to enrollment; 8. Patients with liver and kidney dysfunction (ALT/AST = 2.5 times ULN, Cr = 1.5 times ULN); 9. Patients with malignant tumors or skin masses of unknown nature in the treatment area; 10. Those who have received chemotherapy, radiation therapy, immunosuppressants, immunomodulatory therapy (such as monoclonal antibodies), or systemic corticosteroids (excluding inhaled corticosteroids) within 6 months prior to enrollment; 11. Known to be continuously using or expected to continue using photosensitive drugs for treatment during the study period; 12. Those who have undergone facial surgery within 6 months prior to enrollment; 13. There are unknown injectable substances in the treatment area; 14. Prior to the screening period or during the study period, the following surgical treatments that may affect this trial are planned: (1) Facial silicone, autologous fat transplantation, facial lifting surgery, non absorbable implant thread (such as polypropylene thread), and permanent dermal fillers (such as polymethyl methacrylate) are planned before the screening period or during the study period; 2.(2) Plan to receive absorbable facial implant thread (such as polycaprolactone thread, poly-p-dioxanone thread, etc.) and semi permanent dermal filler (such as hydroxyapatite, polycaprolactone, etc.) treatment within 24 months before enrollment or during the study period; 3.(3) 12 months prior to enrollment or during the study period, plan to receive temporary fillers such as facial cross-linked hyaluronic acid or collagen injection therapy; 4.(4) Plan to receive facial non crosslinked hyaluronic acid injection therapy within 6 months before enrollment or during the study period; 5.(5) Plan to receive facial botulinum toxin injection, radiofrequency therapy, ultrasound therapy, skin grinding surgery and other treatments within 6 months before enrollment or during the study period; 3. Clinical trial plan for injection of sodium hyaluronate composite solution. 4 (6) Patients who plan to receive facial laser or chemical skin rejuvenation treatment within 3 months before enrollment or during the study period; 15. Tattoos, scars, deformities, unhealed wounds, or precancerous lesions on the face that may affe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. GAIS scoring therapy is efficient (blind evaluation researchers' evaluation), 2. Improvement rate of comprehensive skin state (blind evaluation researchers' evaluation); | — |
Countries
China
Contacts
Public Contactwang hang
West China Hospital of Stomatology, Sichuan University
Outcome results
None listed