Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of YVOIRE Classic Versus Restylane in Nasolabial Fold Intradermal Injection

LG Life Sciences

Status: Completed

Conditions: Temporary Correction of Wrinkles

Treatments: Device: Restylane; Device: HA IDF (YVOIRE classic)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03738020

LG-HACL008

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups

HA IDF

Experimental group

Treatment:

Device: HA IDF (YVOIRE classic)

Restylane

Active Comparator group

Treatment:

Device: Restylane