Facial smoothness
Conditions
Interventions
Intervention group:The injection will be performed using equipment on the cheek area. The injection will be carried out by the injection researcher using the experimental equipment on the research par
Control group:Participants in the control group did not receive treatment and were followed up at 1, 3, and 6 months after randomization.
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18 - 65 years old (based on the date of signing the informed consent form, inclusive of the boundary value), gender not restricted; 2. Fitzpatrick skin type II - IV; 3. According to the assessment by the blinded researchers, the Allergan Skin Roughness Scale (ASRS) rating for the roughness of both cheeks is level 2 or 3, and there is a need for improvement in cheek roughness; 4. The research participants voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those with a history of severe allergies or anaphylactic shock, or whose medical history indicates that allergies may lead to a reaction to the treatment; 2. Those who are known to be allergic to sodium hyaluronate or any component of this product, or any local anesthetic drugs (such as lidocaine or other amide-type anesthetic drugs); 3. Those with tattoos, scars, deformities, unhealed wounds, active skin diseases or skin inflammations (such as herpes, acne, eczema, dermatitis, psoriasis, shingles, etc.), abscesses, cancerous or precancerous lesions, etc. in the injection and evaluation areas that may affect the evaluation of therapeutic effect or increase the risk of treatment; 4. Those who have received or plan to receive any permanent filler (such as polymethyl methacrylate, silicone, expanded polytetrafluoroethylene, etc.) or autologous fat or facial lifting sutures or unknown injection substances in the injection and evaluation areas during the trial; 5. Those who have received or plan to receive any treatment such as calcium hydroxyapatite (CaHA), polybutylene succinate (PCL), or those who have received or plan to receive internal poly-L-lactic acid (PLLA), cross-linked hyaluronic acid treatment, etc. in the injection and evaluation areas within 24 months before the screening; 6. Those who have received or plan to receive collagen treatment, non-cross-linked sodium hyaluronate injection filling treatment, or any anti-wrinkle treatment (such as botulinum toxin injection, intense pulsed light, radiofrequency, dermabrasion, laser, chemical peeling, etc.) in the injection and evaluation areas within 6 months before the screening; 7. Those who have received chemotherapy, immunosuppressants, immunomodulatory therapy (such as monoclonal antibodies, etc.) or systemic corticosteroids (except inhaled corticosteroids) within 3 months before the screening; 8. Those who have received surgery in the injection and evaluation areas and whose efficacy evaluation is affected by the surgery; 9. Those with active autoimmune diseases or medical history (such as systemic lupus erythematosus, rheumatoid arthritis, scleroderma, dermatomyositis, etc.), active sepsis; 10. Those who are prone to form keloids, hypertrophic scars or any abnormal healing conditions; 11. Those with a history of bleeding disorders (such as porphyria, factor deficiency, coagulation disorders or thrombocytopenia), clinical significance of abnormal coagulation function tests during the screening (such as APTT > 1.5 times the upper limit of the normal value), or those who have received anticoagulant, antiplatelet or thrombolytic treatment (such as warfarin, heparin, aspirin, etc.) within 2 weeks before the screening; 12. Those whose important organs (such as brain, heart, lungs, liver, kidneys, etc.) have severe dysfunction, such as severe cardiovascular and cerebrovascular diseases (hospitalization due to myocardial infarction or heart surgery within 3 months, congestive heart failure or history of myocardial infarction, severe unstable arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysm, stroke, etc.), severe pulmonary diseases (moderate to severe pneumonia, respiratory failure, etc.), epilepsy, liver function tests showing ALT and/or AST > 2 times the upper limit of the normal value, kidney function tests showing Cr > 1.5 times the upper limit of the normal value, research participants who have had uncontrolled diabetes, etc.; 13. Those who plan to underg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The blind reviewers' ratings of the ASRS scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| The blind reviewers' scoring of the AFLS scale;The on-site evaluation researchers' scoring of the ASRS scale;The on-site evaluation researchers' scoring of the AFLS scale;The scores given by the research participants to the GAIS scale;Evaluation of skin moisture content changes;Post-visual Analogue Scale (VAS) pain score;Satisfaction evaluation; | — |
Countries
China
Contacts
Public ContactZhao Hongyi
Beijing Hospital
Outcome results
None listed