Nasolabial folds
Conditions
Interventions
Investigational Medical Device:Dermal filler injection with Investigational Medical Device
Control device:Dermal filler injection with Control device
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained from subject 2. Chinese male or female subject = 18 years old 3. Subject desires bilateral NLF treatment 4. Has symmetrical NLFs, with the same wrinkle severity rating scale (WSRS) score of 3 (moderate) or 4 (severe) for both right and left NLFs, as determined on live assessment by the blinded evaluator that requires at least 0.5 mL of HA filler. 5. Subject understands and accepts the obligation to follow study instructions and is logistically able to present for all scheduled study visits and meet all study requirements. 6. Subject is willing to abstain from all aesthetic procedures (e.g., dermal fillers outside of this study, toxin treatments, facial ablative or fractional laser, intense pulsed light [IPL], microdermabrasion, chemical peels, skin bleaching agents, non-ablative laser or energy-based device for skin-tightening, and surgical procedures) in the NLFs and the mid face (ocular fissure to oral fissure) during participation in the study. 7. Woman of childbearing potential must be using a highly effective method of birth control.
Exclusion criteria
Exclusion criteria: 1. Any previous treatment with silicone, polymethyl methacrylate, fat injections, poly L-lactic acid, or permanent dermal fillers in the NLFs and the mid face (ocular fissure to oral fissure) 2. Prior facial surgery (e.g., facial lifting), thread lift or any unknown treatments within the past three years in the NLFs and the mid face (ocular fissure to oral fissure) 3. Prior treatment with calcium hydroxylapatite or with crosslinked volumizing HA fillers such as but not limited to Juvéderm® Voluma, Restylane® Lyft within the past 18 months in the NLFs and the mid face (ocular fissure to oral fissure) 4. Prior treatment with crosslinked HA filler within the past 12 months in the NLFs and the mid face (ocular fissure to oral fissure) 5. Prior treatment with non-crosslinked HA filler (mesotherapy) within the past six months in the NLFs and the mid face (ocular fissure to oral fissure). 6. Prior treatment with dermal therapies within the past six months (e.g., facial ablative or fractional laser, microdermabrasion, and non-ablative laser or energy-based devices for skin-tightening) in the NLFs and the mid face (ocular fissure to oral fissure) 7. Prior treatment with dermal therapies within the past three months (e.g., IPL, chemical peels, and skin bleaching agents) in the NLFs and the mid face (ocular fissure to oral fissure). 8. Prior treatment with cosmetic procedures (e.g., facials) or home peeling in the past two weeks in the NLFs and the mid face (ocular fissure to oral fissure). 9. Has received neurotoxin treatment in the mid face (ocular fissure to oral fissure) within the past four months or plans to receive such treatment in the mid face (ocular fissure to oral fissure) 10. Subject taking anti-coagulation, anti-platelet, or thrombolytic medications (e.g., phenprocoumon, warfarin, heparin, clopidogrel), non-steroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen, diclofenac) ten days prior and up to three days post investigational medical device (IMD) or comparator application or with known bleeding disorder(s) 11. Hypersensitivity to one of the IMD or comparator components, e.g., sodium hyaluronate, BDDE, lidocaine or anesthetics of the amide type, or any of the device components, or presenting a history of severe multiple allergies or anaphylactic shock. 12. Congenital methemoglobinemia, with glucose-6-phosphate dehydrogenase deficiencies, or is receiving concomitant treatment with methemoglobin-inducing agents. 13. History of streptococcal diseases (e.g., chronic recurrent angina) or known allergy against gram positive bacterial proteins. 14. History of hyper- or hypopigmentation, keloid formation, or hypertrophic scarring. 15. Acute inflammatory process or infection at the injection site (e.g., acne, rashes, cysts), or history of chronic or recurrent infection (e.g., herpes, pityriasis rosea in the NLFs and the mid face [ocular fissure to oral fissure]) or inflammation with the potential to interfere with the study results or increase the risk of adverse events (AEs). 16. Any medical condition with the potential to interfere with the study or increase the risk of AEs (e.g., epilepsy, impaired cardiac conditions, severely impaired hepatic function, severe renal dysfunction, porphyria, severe psychic, neurological or mental disease, current or history of drug or alcohol abuse, general infection). 17. History or documented evidence of an active autoimmune disease (e.g., scleroderma, systemic lupus erythematosus, rheumatoid ar
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of responder; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of responder;Proportion of subjects with at least "+ 1 improved";Proportion of subjects with at least "+ 1 improved"; | — |
Countries
China
Contacts
Public ContactYan Wu
Peking University First Hospital
Outcome results
None listed