Nasolabial folds
Conditions
Interventions
experimental group:YiShuMei
Sponsors
Tenth People's Hospital Affiliated to Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Chinese male or female aged 18-65 years; (2) Voluntary signing of informed consent; (3) The bilateral nasolabial sulcus wrinkles were symmetrical, and the severity of wrinkles assessed by WSRs was no less than 3; (4) They have enough language understanding ability and voluntarily complete the whole study according to the relevant research plan.
Exclusion criteria
Exclusion criteria: (1) Allergic history, including local anesthetics (lidocaine, etc.), sodium hyaluronate preparations, and / or gram positive bacterial protein allergy; (2) A history of keloid or hemorrhagic disease is known; (3) The nasolabial sulcus has active inflammation (such as cyst, papule, rash, canceration / precancerous lesion, psoriasis, neurodermatitis, or any other active skin disease, skin rash) or severe scar, which may interfere with the researcher's evaluation; (4) Women who are pregnant or lactating, or who are going to be pregnant during the trial; (5) In the course of the study, major facial operations are planned, such as augmentation rhinoplasty, plastic surgery, repair of congenital defects, etc; (6) Accompanied by severe systemic diseases, such as significant laboratory abnormalities, myocardial infarction, stroke, cancer, connective tissue diseases (scleroderma, systemic lupus erythematosus), systemic infection, uncontrolled diabetes, etc. And those who may need to be treated with immunosuppressive drugs during the trial period (severe and uncontrolled asthma, rheumatoid arthritis, autoimmune diseases, etc.); (7) Those with serious physical, neurological and mental diseases; (8) Excessive facial hair may affect the evaluation of wrinkles; (9) Botulinum toxin type A was injected below zygomatic arch level within 6 months before the screening period; (10) One year before the screening period, non permanent cosmetic filling products (such as collagen, sodium hyaluronate, autologous fat, etc.) were filled in the nasolabial sulcus area; (11) Those who had permanent filling in nasolabial sulcus at any time before the screening period or during the study period (such as silicone, fat, PMMA containing products, such as Artecoll, preformed implants, etc.); (12) In the 8 weeks before the screening period, the patients were treated with Photorejuvenation, non exfoliative lattice laser, medium / deep chemical exfoliation and skin grinding; (13) Two weeks before the screening period, facial anti wrinkle products, topical steroids, skin irritant drugs, or colorants, immunosuppressive drugs or systemic steroids (oral prednisone) were used. However, intranasal / inhaled steroids should not be excluded in the 8 weeks before the screening period; (14) Anticoagulant therapy (e.g. heparin, coumarin derivatives) or antiplatelet therapy (e.g. aspirin, dipyridamole) were used within 2 weeks before the initial injection. Low dose aspirin (325 mg per day) is not excluded to prevent heart disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WSRS; | — |
Countries
China
Contacts
Public ContactYuling Shi
Tenth People's Hospital Affiliated to Tongji University
Outcome results
None listed