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

NCT ID: NCT03738020

Last Updated: 2019-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Temporary Correction of Wrinkles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

IND approved from KFDA
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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HA IDF

Group Type EXPERIMENTAL

HA IDF (YVOIRE classic)

Intervention Type DEVICE

Treatment with HA IDF

Restylane

Group Type ACTIVE_COMPARATOR

Restylane

Intervention Type DEVICE

Treatment with Restylane

Interventions

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HA IDF (YVOIRE classic)

Treatment with HA IDF

Intervention Type DEVICE

Restylane

Treatment with Restylane

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LG Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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LG-HACL008

Identifier Type: -

Identifier Source: org_study_id