Shape lip red margin and lip red body
Conditions
Interventions
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Gender unlimited, age 18-60 years old (inclusive); 2. Those who scored 1, 2 or 3 on the Allergan Lip Fullness Scale (ALFS) (see Annex 1) (evaluated by blind researchers); 3. There is a need for thickening lips; 4. Voluntarily participate in this clinical trial and sign the subject informed consent. 5. Able and willing to follow the investigator's instructions, follow the medication and treatment restrictions specified in this protocol, and complete all visits in this study as required.\
Exclusion criteria
Exclusion criteria: 1. Patients with perioral infections, lesions, inflammation and skin diseases during the screening period; 2. Lip injection of permanent fillers; 3. Those who have used non-permanent fillers or laser treatment, chemical peels and other treatments that irritate the skin in and around the lips within 6 months; 4. Patients with abnormal coagulation mechanism (APTT > 1.5 times the upper limit of normal) during the screening period, or who have received anticoagulation, antiplatelet or thrombolytic therapy (such as warfarin, aspirin, etc.) within two weeks; 5. previous history of allergy to lidocaine or amide local anesthetics, hyaluronic acid products; 6. Patients with a history of severe allergic reactions and multiple severe allergic reactions; 7. evaluators with piercings, scars, deep lip lines, and maxillofacial deformities that affect visual effects; 8. Serious diseases of important organs, or autoimmune diseases, such as rheumatism, lupus erythematosus, or immune dysfunction during the screening period; 9. Those who plan to undergo middle and lower facial fillings and perilip surgery within one year; 10. Pregnant or lactating women, or those who plan to become pregnant within one year; 11. Participants who participated in other clinical trials within 3 months before this trial; 12. Participants considered inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of lip fullness 3 months after last injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lip red height;The researchers' rating of Global Beauty Effect (GAIS);Subjects' ratings of global Beauty Effect (GAIS);NRS pain score;Subject satisfaction evaluation;Injection investigator lip fullness score; | — |
Countries
China
Contacts
Public ContactXu Jinhua Wu Wenyu
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed