skin condition
Conditions
Interventions
Control Group:none
Sponsors
Beijing Friendship Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age = 18 years and = 65 years, gender not limited; 2) Skin Fitzpatrick type II-IV; 3) Facial skin with one of the following conditions: dull skin tone, dryness, slightly reduced elasticity, fine wrinkles, and a temporary need for improvement; 4) Agree not to use other cosmetic treatments related to the study during the research period; 5) Voluntarily sign an informed consent form, understand and accept the duration of the study, able and willing to comply with all requirements, including following the treatment plan, maintaining daily skincare habits, participating in follow-up visits, and other research procedures.
Exclusion criteria
Exclusion criteria: 1) Allergic to hyaluronic acid products, or any local anesthetics (such as lidocaine or other amide-type local anesthetics), or with a known history of hypersensitivity reactions; 2) Presence of local skin infections (including viral, bacterial, fungal) or severe systemic infections; 3) Presence of skin granulomas, keloid-prone individuals; 4) Patients with immune system diseases (such as systemic lupus erythematosus, rheumatoid arthritis, scleroderma, dermatomyositis, etc.); 5) Active or progressive skin diseases in the treatment area, or skin diseases with similar reactions, such as acute eczema, flat warts, flat lichen, psoriasis vulgaris, acne, contact dermatitis, atopic dermatitis, herpes simplex, herpes zoster, vitiligo, etc., and presence of tattoos, scars, deformities, unhealed wounds on the face; 6) Abnormal coagulation mechanism during the screening period (activated partial thromboplastin time (APTT) >1.5 times the upper limit of normal (ULN)), or having received any thrombolytic, anticoagulant, or antiplatelet drugs (such as warfarin, aspirin, etc.) within 2 weeks before enrollment; 7) Presence of malignant tumors or skin nodules of unknown nature in the treatment area; 8) Received any permanent or semi-permanent fillers (such as hydroxyapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene, polycaprolactone, etc.), autologous fat, facial lifting procedures (including thread embedding) on the face within 1 year before enrollment; 9) Patients judged by the investigator to have severe organ dysfunction (such as brain, heart, lung, liver, kidney, etc.) or malignant tumors, such as severe cardiovascular diseases (hospitalization for myocardial infarction or heart surgery, history of congestive heart failure or myocardial infarction within 3 months, severe unstable arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysm, stroke, etc.), severe lung diseases (moderate to severe pneumonia, respiratory failure, etc.), uncontrolled diabetes, epilepsy, liver function (alanine aminotransferase (ALT), aspartate aminotransferase (AST)) >2 times ULN, renal function (creatinine (Cr)) >1.5 times ULN; 10) Received or currently receiving chemotherapy/radiotherapy/immunosuppressive therapy within 6 months before enrollment; 11) Patients with mental disorders or emotional instability; 12) Pregnant or lactating women, or planning to become pregnant during the study period; 13) Long-term outdoor work or potential exposure to strong sunlight after surgery, known continuous use or expected continuous use of photosensitive drugs during the study period; 14) Presence of unknown injectables in the treatment area; 15) Unrealistically high expectations for treatment outcomes; 16) Participation in similar treatments, including radiofrequency, photonic, botulinum toxin injections, within 6 months before enrollment; 17) Participation in or currently participating in drug or medical device clinical trials within the past month; 18) Deemed unsuitable for participation in the clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall improvement rate 28 days after the last injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall improvement rate 28 days after the first injection, 28 days after the second injection, and 7 and 14 days after the last injection;Improvement in skin physiological indicators;Aesthetic Skin Roughness Scale score;Aesthetic Fine Line Scale score;Blind assessment by researchers of the overall cosmetic effect through photographs;Subjects' assessment of the overall cosmetic effect; Subjects' satisfaction assessment; | — |
Countries
China
Contacts
Public ContactXu Wei
Department of Dermatology, Beijing Friendship Hospital, Capital Medical University
Outcome results
None listed