Nasolabial folds
Conditions
Interventions
Two groups:dermal filler injection
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. No less than 18 years; 2. At the time of screening, the independent blind evaluator evaluated the symmetrical nasolabial fold wrinkles as moderate (score 3) according to WSRS (the ratings on both sides of the face are the same); 3. Hope to correct bilateral nasolabial wrinkles; 4. Women with the possibility of pregnancy must take effective contraceptive measures. The serum pregnancy test must be negative when screening, and the urine pregnancy test must be negative at baseline.
Exclusion criteria
Exclusion criteria: 1. The subject has undergone surgery or permanent implantation or left scars at the site to be treated; 2. The site to be treated has received silicone, polymethylmethacrylate, fat injection, poly L-lactic acid or permanent subcutaneous filler; 3. The area to be treated has been treated with hyaluronic acid (HA) filler in the past 12 months; 4. In the past six months, the face has received or plans to receive skin treatment during the study (such as toxin treatment, facial laser cauterization or dot matrix laser, microcrystalline skin replacement, chemical skin replacement; 5. non-invasive skin tightening, hair removal and surgical treatment); 6. It is known that it is allergic to a certain component of the test medical device, such as sodium hyaluronate, lidocaine or amide anesthetics, or any other component of the device; 7. Have a history of hyperpigmentation or hypopigmentation, scar formation, or hypertrophic scar; 8. There is acute inflammation or infection (such as acne, rash, cyst, etc.) at the injection site, or chronic or recurrent infection (such as herpes) or inflammation history that may interfere with the research results or increase the risk of adverse events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrinkle Severity Rating Scale (WSRS); | — |
Countries
China
Contacts
Public ContactWenzhi Li
Beijing Anzhen Hospital
Outcome results
None listed