Clinical Study to Evaluate the Correction of Facial Wrinkles and Folds and Safety of YVOIRE Volume Versus Perlane in Nasolabial Fold Injection

LG Life Sciences

Status: Completed

Conditions: Temporary Correction of Wrinkles

Treatments: Device: HA IDF II; Device: Perlane

Study type: Interventional

Funder types: Industry

Identifiers

NCT03738007

LG-HACL009

Details and patient eligibility

About

This study was purposed to evaluate the non-inferiority of YVOIRE volume, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold deep-dermal injection, compared to Perlane, the control preparation.

Enrollment: 57 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
3. Those 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 form.

Exclusion criteria

1. Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.)
2. Those with a history of severe allergy
3. Those with hypertrophic scar or a history of kelloid
4. Patients with an autoimmune disease
5. Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
6. Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study
7. Those who had underwent a chemical peeling, laser procedure (including IPL) or insertion of other bioadaptive materials (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).
8. Patients with a malignant tumor
9. Women in pregnancy or lactation
10. Hepatitis carriers or VDRL/HIV positive patients
11. Those with a hypersensitivity to the investigational medical device of this study
12. 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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57 participants in 2 patient groups

HA IDF II

Experimental group

Treatment:

Device: HA IDF II

Perlane

Active Comparator group

Treatment:

Device: Perlane