Correction of Nasolabial Folds
Conditions
Brief summary
A Study to Evaluate the Performance and Safety of YVOIRE Classic plus on NLF.
Detailed description
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Classic plus Versus Comparator for Temporary Correction of Nasolabial Folds.
Interventions
DEVICEHyaluronic acid dermal filler
Hyaluronic acid dermal filler used for facial volume or wrinkle correction
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female 21 years or above age. * 2 or 3 of the 5-point (0-4) NLFRS (Nasolabial Fold Rating Scale). * Agree to use proper contraception as guided in the protocol. * Signed for Informed Consent.
Exclusion criteria
* have received permanent facial implants anywhere in the face or neck or planning during the investigation. * have undergone facial plastic surgery of the lower face and nasolabial region within 12 weeks * have undergone semi-permanent filler in lower face * have undergone temporary dermal filler treatment in the lower two-thirds of face within 12 months * Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower two-thirds of face * Have undergone mesotherapy or cosmetic procedures in face or neck within 6 months * have used any over-the-counter anti-wrinkle products or prescription anti-wrinkle medicines for the nasolabial folds within 28 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change on the Nasolabial Fold Rating Scale (NLFRS) from baseline to Week24. | 24 weeks from baseline | To evaluate the performance of YVOIRE Classic plus on Nasolabial Fold 24 weeks after treatment, the mean change from baseline to 24 weeks will be measured using 5-point Nasolabial Fold Rating Scale (NLFRS). NLFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Extreme). |
| Responder rate calculated using Nasolabial Fold Rating Scale (NLFRS) for Nasolabial fold at Week 24. | 24 weeks from baseline | To evaluate the performance of YVOIRE Classic plus on Nasolabial fold 24 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Nasolabial Fold Rating Scale (NLFRS) from baseline to 24 weeks will be calculated. |
Countries
Germany
Outcome results
None listed