None listed
Conditions
Interventions
Experimental group:Crosslinked sodium hyaluronate gel for injection produced by French SYMATESE SAS
control group:Crosslinked sodium hyaluronate gel for injection containing lidocaine produced by ALLERGAN
Sponsors
Guangdong Second Provincial General Hospital (Guangdong Provincial Emergency Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 or above; 2. Patients with Grade 0~2 upper and lower lips based on the LFS assessment, which, according to the investigator’s judgment, can be improved by at least one grade (>=1) who are seeking lip volume and /or shape enhancement; 3. Subjects or their legally authorized representatives can understand the objective of the study, show compliance with the study protocol, and sign the informed consent forms.
Exclusion criteria
Exclusion criteria: 1. Patients having scars, tattoos, piercings, or facial hair on the lips or around the mouth, or having severe abnormal lip asymmetry, which, according to the investigator’s judgment, could interfere with effectiveness assessments; 2. Patients having any lump, unhealed would, or diagnosed active infection or inflammation (such as dermatitis, eczema, acne, herpes, bacterial and viral infection of facial skin) on the lips or around the mouth; 3. Patients diagnosed with cancerous or precancerous lesions in the facial region; 4. Patients with severe malocclusion or dentofacial or maxillofacial deformities; 5. Patients having dentures or any device covering the upper or lower palate; 6. Patients diagnosed with epilepsy, severe organ failure, malignant tumor, autoimmune disease, third degree atrioventricular block, or uncontrolled type 1 or 2 diabetes; 7. Patients diagnosed with skin pigmentation disorders or tissue healing disorder disorders on the lips or around the mouth; 8. Patients who had received permanent implants or fillers on the lips or around the mouth; 9. Patients who had undergone semi-permanent dermal filler treatment (e.g., poly-L lactic acid) in the lower face (below the orbital rim) within 24 months before enrollment; 10. Patients who had undergone temporary dermal filler treatment (e.g., sodium hyaluronate or collagen) in the face within 12 months before enrollment; 11. Patients with a history of herpes labialis who had four (4) or more outbreaks in the 12 months prior to enrollment or had any outbreaks within the past 4 weeks prior to enrollment; 12. Patients who had undergone facial tissue augmentation with fat injections, botulinum toxin injections in the lower face, or cosmetic procedures in the face (e.g., face-lift, laser, photo-modulation, intense pulsed light, radio frequency, dermabrasion, chemical peel) within 6 months before enrollment; 13. Patients who had undergone orthodontic treatment or oral surgery within 6 months before enrollment or plan to undergone during 12 months after enrollment; 14. Patients who had ever received chemotherapy or systemic steroid therapy within 3 months before enrollment; 15. Patients who had used topical medication on the lips or around the mouth within 2 weeks before enrollment; 16. Patients who had used drugs known to prolong coagulation time (such as warfarin, aspirin, clopidogrel, ticagrelor) within 2 weeks before enrollment; 17. Patients who had used any capsaicine or similar substance containing lip product or anti-wrinkle claim products around the mouth within 10 days before enrollment; 18. Patients with vitiligo or psoriasis in active stage; 19. Patients with a history of streptococcus infection or porphyria; 20. Patients with a history of allergic reactions to lidocaine, amide local anesthetics, or sodium hyaluronate; 21. Patients with severe blood coagulation disorders (PT or APTT >= 3 times the upper limit of normal value); 22. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 3 times the upper limit of normal value; 23. Patients with blood urea nitrogen (BUN) or serum creatinine (Cr) >= 3 times the upper limit of normal value; 24. Patients with severe hypertension (systolic pressure >=160 mmHg or diastolic pressure >=100 mmHg after control); 25. Pregnant or breastfeeding women; 26. Patients who participated in any other interventional clinical study within 90 days before enrollment; 27. Other circumstances that the investigators consider
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to week 12 after last injection on LFS grade; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event occurrence rate;Incidence of adverse events;Assessment of Global Aesthetic Improvement Scale (GAIS) at scheduled follow-up visits;LFS responder rates at scheduled follow-up visits;LFS assessment at scheduled follow-up visits;Change from baseline on LFS grade at scheduled follow-up visits;VAS score for pain in the injection area on the 1st, 7th, and 14th day after each injection;VAS score for pain in the injection area within 30 minutes after each injection;Lip functionality and sensation assessment at scheduled follow-up visits;Incidence of side reactions;Specific follow-up natural appearance and sensation evaluation questionnaire;Specific follow-up Face-Q score;Treatment satisfaction at the last follow-up visit;Treating investigator questionnaire on the day of each injection and week 12 after last injection;Lip volume change at scheduled follow-up visits; | — |
Countries
China
Contacts
Public ContactShengkang Luo
Guangdong Second Provincial General Hospital (Guangdong Provincial Emergency Hospital)
Outcome results
None listed