Nasolabial folds
Conditions
Interventions
Group 1:Left side: Belotero Volume Lidocaine
Right side: Restylane
Group 2:Left side: Restylane
Right side: Belotero Volume Lidocaine
Sponsors
Shanghai Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. At least 18 years of age, upper age limit is 75 years old; 2. Symmetrical NLFs (with identical rating on both sides of the face) of severe intensity (grade 4) on the WSRS as determined by the independent blinded evaluator at screening; 3. Desires correction of both NLFs; 4. Woman of childbearing potential must be using a highly effective method of birth control and must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.
Exclusion criteria
Exclusion criteria: 1. Subject has ever had surgery or has surgical permanent implant or scar(s) in the area to be treated; 2. Subject has ever been treated with silicone, polymethyl methacrylate, fat injections, poly L-lactic acid, or permanent dermal fillers in the area to be treated; 3. Subject has been treated within the past 12 months with hyaluronic acid (HA) filler in the area to be treated; 4. Subject has received within the past 6 months or plans to receive dermal therapies (e.g., toxin treatments, facial ablative or fractional laser, microdermabrasion, chemical peels, non-invasive skin-tightening, epilation, and surgical procedures) in the face during participation in the investigation; 5. Subject has known hypersensitivity to one of the IMDs components, e.g., sodium hyaluronate, lidocaine or anesthetics of the amide type, or any of the device components; 6. Subject has a history of hyper- or hypopigmentation, keloid formation, or hypertrophic scarring; 7. Subject has acute inflammatory process or infection at the injection site (e.g., acne, rashes, cysts), or history of chronic or recurrent infection (e.g., herpes) or inflammation with the potential to interfere with the investigation results or increase the risk of adverse events (AEs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrinkle Severity Rating Scale (WSRS); | — |
Countries
China
Contacts
Public ContactLi Qingfeng
Shanghai Ninth People’s Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed