Aging Problems
Conditions
Brief summary
The investigators aimed to evaluate the efficacy and safety of new HA filler for nasolabial fold correction
Detailed description
A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was conducted to compare the clinical efficacy and safety of new HA filler versus Juvederm for nasolabial fold correction
Interventions
DRUGCUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea)
Hyaluronic acid filler injection were administered into the mid-dermis of the nasolabial fold.
DRUGJuvedermⓇ (Q-Med AB, Uppsala, Sweden)
Hyaluronic acid filler injection were administered into the mid-dermis of the nasolabial fold.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients who had prominent NLFs with a WSRS score of 3 or 4 on both sides
Exclusion criteria
* patients with active facial skin diseases or history of severe allergies, autoimmune disorders, or hypersensitivity to HA or any of the excipients contained in the investigational filler * participants who had used a local topical preparation (steroid and retinoid) within 2 weeks before the study * participants who had undergone chemical peeling, laser procedures, or acne treatments within 4 months before the study * participants who had been injected with other biomaterials, including HA within 6 months before the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WSRS | at 24 weeks after treatment | Wrinkle Severity Rating Scale from 1 (no visible fold) to 5 (extremely deep and long folds) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GAIS | at 24 weeks after treatment | Global Aesthetic Improvement Scale from 3 (very much improved) to -1 (worse). |
| Adverse events related to the procedure | up to 24 weeks | Patients were required to report any adverse events up to 24 weeks |
Countries
South Korea
Outcome results
None listed