Temporary Correction of Wrinkles
Conditions
Brief summary
This study was purposed to evaluate the non-inferiority of HA IDF, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold intradermal injection, compared to Restylane, the control preparation.
Interventions
DEVICEHA IDF (YVOIRE classic)
Treatment with HA IDF
DEVICERestylane
Treatment with Restylane
Sponsors
LG Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
IND approved from KFDA
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age: Women in 30\ 55 years. 2. Those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically and who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent.
Exclusion criteria
1. Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.) or those with a history of severe allergy. 2. Patients with a disorder in autoimmune system 3. Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly 4. Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study. 5. Those who had underwent a chemical peeling, laser procedure (including IPL) or insertion of other bioadaptive material within 3 months prior to the study (however, those who had been treated with HA filler could participate in the study if the date of treatment was known and the investigator judged that the filler effect had disappeared). 6. Patients with a malignant tumor 7. Women in pregnancy or lactation 8. Hepatitis carriers or VDRL/HIV positive patients 9. Those with a hypersensitivity to the investigational medical device of this study 10. Other persons including those considered as difficult to perform this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average of Wrinkle Severity Rating Scale (WSRS) Score Evaluated by the Evaluating Investigator at Week 26 (Visit 7) After the Final Treatment With the Investigational Medical Device | Week 26 (Visit 7) | Wrinkle Severity Rating Scale (WSRS) 1. Absent: no visible fold; continuous line 2. Mild: Shallow but visible fold with slight indentation; minor facial feature 3. Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected. 4. Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched 5. Extreme: extremely deep and long folds; 2-4mm visible v-shaped fold when stretched; detrimental to appearance; unlikely to have satisfactory correction with injectable implant alone |
Participant flow
Pre-assignment details
spilt-face design
Participants by arm
| Arm | Count |
|---|---|
| HA IDF and Restylane Subjects who were included in efficacy evaluation | 58 |
| Total | 58 |
Baseline characteristics
| Characteristic | HA IDF and Restylane |
|---|---|
| Age, Continuous | 44.40 years STANDARD_DEVIATION 5.82 |
| Region of Enrollment South Korea | 58 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 58 | 3 / 58 | 5 / 58 |
| serious Total, serious adverse events | 0 / 58 | 0 / 58 | 0 / 58 |
Outcome results
Primary
Average of Wrinkle Severity Rating Scale (WSRS) Score Evaluated by the Evaluating Investigator at Week 26 (Visit 7) After the Final Treatment With the Investigational Medical Device
Wrinkle Severity Rating Scale (WSRS) 1. Absent: no visible fold; continuous line 2. Mild: Shallow but visible fold with slight indentation; minor facial feature 3. Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected. 4. Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched 5. Extreme: extremely deep and long folds; 2-4mm visible v-shaped fold when stretched; detrimental to appearance; unlikely to have satisfactory correction with injectable implant alone
Time frame: Week 26 (Visit 7)
Population: Spilt-face design
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HA IDF | Average of Wrinkle Severity Rating Scale (WSRS) Score Evaluated by the Evaluating Investigator at Week 26 (Visit 7) After the Final Treatment With the Investigational Medical Device | 2.56 score on a scale | Standard Deviation 0.68 |
| Restylane | Average of Wrinkle Severity Rating Scale (WSRS) Score Evaluated by the Evaluating Investigator at Week 26 (Visit 7) After the Final Treatment With the Investigational Medical Device | 2.56 score on a scale | Standard Deviation 0.66 |