Moderate to severe nasolabial fold wrinkles
Conditions
Interventions
Group 2:Positive control
Group 1:modified sodium hyaluronate gel (DermalaxTM DEEP)
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 25~65 years male and female; 2. The severity grading of the wrinkles in the bilateral nasolabial furrows (WSRS) of the subjects was assessed at level 3 or 4 (the severity grading grading of the left and right sides of the subjects could be inconsistent); 3. No facial skin surgery or treatment is planned for 1 year, including face dermabrasion surgery; 4. The researcher believes that the subjects understand the purpose and design of this clinical study and have reasonable expectations on the possibility of improving aesthetic appearance by the correction of nasolabial furrow wrinkles; 5. Subjects have good compliance, are able and willing to follow the study guidance, follow the prescribed medication and treatment restrictions in this program, and complete all study visits as required; 6. Subjects voluntarily sign informed consent before participating in the test.
Exclusion criteria
Exclusion criteria: 1. Previous hypersensitivity to a variety of allergens, hypersensitivity to hyaluronic acid products or streptococcal proteins, or desensitization treatment planned during this study; 2. Facial hair (such as mustache and beard), obvious scars (such as hypertrophic scars of nasolabial follicle), active inflammation, infection, cancerous or precancerous lesions, and/or unhealed wounds on the face, which may affect the evaluation of the efficacy of the photographs; 3. During the first 4 weeks of screening, external drugs were used in the nasolabial groove (such as glucocorticoid and retinoic acid ointment); 4. Screening those who had undergone dental surgery, tooth extraction or dental implant within 3 months before the screening; 5. In the first 6 months of screening, facial botulinum toxin injection, laser skin replacement, skin rejuvenation, intense pulsed light, radiofrequency, grinding, chemical stripping or other ablation or non-ablation operations were performed; 6. Screened patients who had undergone plastic surgery and received sodium hyaluronate gel injection on the face within 12 months before the screening; 7. At any time in the past, fat injection or tissue transplantation was performed on any part of the face, or tissue filling surgery was performed using silica gel, hydroxyapatite calcium, polymethyl methacrylate, poly-l-lactic acid or other permanent, semi-permanent or unknown dermal filler; 8. He had a history of bleeding tendency or are contained in other disease treatment drugs known to prolong clotting time (for example, aspirin and non-steroidal anti-inflammatory drugs (nsaids), clopidogrel, and warfarin, large doses of vitamin C or E, herbal supplements containing garlic, ginkgo or ginseng), within 2 weeks before screening unwilling or unable to stop using these drugs. However, for the menstrual period subjects, the study product injection can be postponed as needed to avoid the menstrual period; 9. Previous history of vitiligo and psoriasis; existing facial skin diseases (such as: dermatitis, eczema, acne, facial skin bacterial virus infection) or scar physique; 10. Plans to undergo other facial treatments or dental procedures, tooth extraction or dental implants at any time during the study period; 11. Any surgery that may result in a significant change in body weight or any medication that may result in a significant change in body weight is planned for the duration of this study (e.g., systemic corticosteroids, weight-loss drugs, bariatric surgery); 12. Those who are allergic to the local anesthetic drugs, such as propivacaine and lidocaine, involved in the study of injection; 13. Infectious diseases, such as syphilis, AIDS and hepatitis b, exist before screening. 14. Any laboratory test indicators prior to screening meet the following criteria: ? alanine amino transaminase (ALT), aspartate aminotransferase (AST) and total bilirubin (DBIL) > 1.5 times the upper limit of normal (ULN) (in reference to the research center laboratory normal range). ? urea nitrogen (BUN), serum creatinine (Cr) > 1.5 times the upper limit of normal (ULN) (in reference to the research center laboratory normal range). ? platelet count (PLT) ? normal lower limit (LLN) (in reference to the research center laboratory normal range). 15. Other general conditions not suitable for participation in the study: ? 3 months prior to screening in any other clinical trials; ? a history of drug ab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| completed 24 weeks after treatment subjects nasolabial furrow wrinkles to correct the efficient (according to the independent assessors WSRS grading assessment points calculated); | — |
Countries
China
Contacts
Public ContactXiaoying Song
Sihuan pharmaceutical holdings group co. LTD
Outcome results
None listed