Mandibular margin skin laxity
Conditions
Interventions
Intervention group:Combined use of Restylane Lyft and Restylane perlane lidocaine
Sponsors
Tongji Hospital Affiliated to Tongji University, Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older with no prior history of serious diseases. 2. Moderate to severe mandibular contour ptosis, i.e., a GJS score of 2 or 3. The GJS scores of the mandibular contour on both sides of the subject need not be identical, but must be either 2 or 3. 3. Assessed by the researchers, the subject's mandibular contour is expected to achieve at least a 1-point improvement in GJS score after hyaluronic acid injection. 4. Willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have undergone or plan to undergo permanent facial prosthetic implantation (e.g., silicone prostheses, etc.) during the study period. 2. Have received or plan to receive dermal filler injections (e.g., autologous fat grafting, hyaluronic acid fillers, regenerative dermal fillers, etc.) in the zygomatic region, chin, or mandibular margin within 18 months prior to enrollment or during the study period. 3. Subjects who have undergone facial photoelectric therapy within 2 weeks before enrollment. 4. Known allergy to any local anesthetics (e.g., lidocaine or other amide - type anesthetics). 5. Patients with abnormal coagulation function (activated partial thromboplastin time [APTT] > 1.5 times the upper limit of normal [ULN]), or those who have received any thrombolytic agents, anticoagulants, or antiplatelet drugs (e.g., warfarin, aspirin, etc.) within 2 weeks prior to enrollment. 6. The lower facial region has tattoos, piercings, prominent facial hair (e.g., beard), scars, deformities, unhealed wounds, active skin diseases, inflammation, or infections (e.g., herpes, acne, eczema, dermatitis, psoriasis, shingles, etc.), abscesses, active or persistent perinasal infections, malignant tumors, or precancerous lesions that may affect efficacy evaluation or increase treatment risks. 7. Subjects with active autoimmune diseases or a history thereof (e.g., systemic lupus erythematosus, rheumatoid arthritis, scleroderma, dermatomyositis, etc.), or those diagnosed with porphyria. 8. Subjects with a tendency to form keloids, hypertrophic scars, or any other wound healing disorders. 9. Have received chemotherapy, immunosuppressants, immunomodulatory therapies (e.g., monoclonal antibodies, etc.), or systemic corticosteroids (excluding inhaled corticosteroids) within 3 months prior to enrollment. 10. Subjects with severe dysfunction of major organs (e.g., brain, heart, lungs, liver, kidneys, etc.) as judged by the investigators; those with severe cardiovascular and cerebrovascular diseases, severe lung diseases, liver function (ALT, AST) > 2 times the ULN, renal function (Cr) > 1.5 times the ULN, and subjects with uncontrolled diabetes mellitus. 11. Subjects who have participated in other clinical trials within 3 months prior to enrollment in this study or are currently participating in other clinical trials. 12. Females who are pregnant or lactating. 13. Women of childbearing age who plan to become pregnant during the study period or do not use effective contraceptive measures (pregnancy test results of female subjects of childbearing age must be negative prior to the first injection); males who plan to have children or are unwilling to use appropriate contraceptive methods. 14. Patients diagnosed with mental illnesses, those without autonomous behavioral capacity, or those with active anxiety or depression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the improvement rate at 6 months after injection compared with the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject satisfaction with the improvement of mandibular contour in Chinese population by Restylane Lyft; | — |
Countries
China
Contacts
Public ContactCui Haiyan
Tongji Hospital Affiliated to Tongji University
Outcome results
None listed