Wrinkles in the Nasolabial Folds
Conditions
Brief summary
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 versus YVOIRE volume plus in Nasolabial Folds Injection
Interventions
DEVICEYVOIRE Y-Solution 540
Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.
DEVICEYVOIRE volume plus
Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 3 (moderate) or 4 (severe) on the 5-graded WSRS * who sign the written informed consent form
Exclusion criteria
* who have received permanent facial implants * who have received semi-permanent fillers * who have undergone temporary dermal filler treatment within 12 months * who have undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic procedures within 6 months * who have a history of anaphylaxis or allergy to lidocaine, hyaluronic acid (HA) products, or streptococcal protein
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WSRS responder rate | 24 weeks after the last injection | the proportion of subjects with ≥ 1 grade improvement on the wrinkle severity rating scale (WSRS) score |
Countries
China
Outcome results
None listed