N/A
N=58
Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of YVOIRE Classic Versus Restylane in Nasolabial Fold Intradermal Injection
Temporary Correction of Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT03738020 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: 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 — 2.56; 2.56 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HA IDF (YVOIRE classic) (Device); Restylane (Device)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- LG Life Sciences
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
2.56; 2.56 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age: Women in 30~55 years.
- 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
- Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.) or those with a history of severe allergy.
- Patients with a disorder in autoimmune system
- Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
- Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study.
- 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).
- Patients with a malignant tumor
- Women in pregnancy or lactation
- Hepatitis carriers or VDRL/HIV positive patients
- Those with a hypersensitivity to the investigational medical device of this study
- Other persons including those considered as difficult to perform this study by the principal investigator
Data sourced from ClinicalTrials.gov (NCT03738020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.