Nasolabial groove wrinkle
Conditions
Interventions
control group:Restylane II
experimental group:linked hyaluronic acid dermal filler with lidocaine
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18~65 years (including 18 and 65 years)male and female; 2) The severity grading of the wrinkles in the bilateral nasolabial grooves (WSRS) of the subjects was assessed at level 3~4; 3) The severity grading grading of the left and right sides of the subjects showing no difference; 4) No related cosmetic treatment is planned during this program; 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 program.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women; 2) Childbearing age women in the experiments are not willing to take birth control methods. Reliable birth control measures include transdermal patches, IUD/IUS, oral, implantation or injection of birth control pills, abstinence and spousal vasectomy; 3) Laboratory test indicating significant abnormal results assessed by researchers; 4) HBsAg, anti-HCV, anti-HIV and/or anti-TP are positive; 5) Participants with scars, skin disease, unhealed wounds and/or active inflammation in treatment areas which may affect the evaluation of the efficacy; 6) At any time in the past, underwent surgeries with silicone implant or other permanent, semi-permanent or unknown dermal filler; 7) Screened patients who had underwent facial lifting plastic surgery benefiting the face wrinkle within 1 year before the screening; 8) Screened patients who had received sodium hyaluronate gel injection or other semi-permanent dermal filler on the face within 1 year before the screening; 9) 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 treatment for facial wrinkle were performed; 10) Within 2 weeks before screening, screened patients have used or are going to receive anticoagulant, antiplatelet or thrombolytic therapy (such as warfarin, aspirin, etc.) 11) Screened patients with previous hypersensitivity to a variety of allergens, hypersensitivity to hyaluronic acid products or streptococcal proteins, or lidocaine, or desensitization treatment planned during this study; 12) Screened patients have a history of serious diseases of important organs or autoimmune diseases; 13) Screened patients have hypertrophic scars, or are in scar constitution; 14) Screened patients who participating in other clinical trials within 30 days before the screening period; 15)Screened patients who are not suitable for this study assessed by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrinkle Severity Rating Scale, WSRS;Global Aesthetic Improvement Scale, GAIS;Degree of Satisfaction;Analysis of 3D scanning image of face; | — |
Countries
China
Contacts
Public ContactZhang Hengshu
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed