A Clinical Study to Evaluate the Efficacy and Safety of YVOIRE Classic Plus Versus YVOIRE Classic in Nasolabial Fold Injection

Study Overview
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Brief Summary
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The objective of this study was to evaluate the efficacy and safety of HA IDF plus (with lidocaine) injected in the nasolabial fold compared to HA IDF (without lidocaine).

Detailed Description
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The objective of this study was to confirm the superiority of HA IDF II plus (with lidocaine) injected in the nasolabial fold compared to HA IDF II (without lidocaine) in the improvement of local pain and evaluate the wrinkle-correcting effect, GAI and safety.

Official Title
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A Randomized, Multi Center, Double-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Efficacy and Safety of HA IDF Plus Versus HA IDF in Nasolabial Fold Injection

Conditions
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Wrinkles

Intervention / Treatment
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* Device: HA IDF plus
* Device: HA IDF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged between 30 and 60 Those whose wrinkles in the treatment area (nasolabial fold) correspond to Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically Those who were informed on the purpose, method, and effect etc. of this study and signed the informed consent form Those who fell under any of the following 3 cases: Surgically sterile women Women in menopause over 2 years from the last menstruation, aged at least 45 Among the women meeting neither of a nor b, those who agreed to use at least 2 contraception methods specified below (one of the barrier methods must be included) until 14 days after the last treatment with the investigational medical device Barrier methods: Condom, diaphragm, cervical cap (pessary), spermicide Hormonal methods: Pills, injection (depot), skin patch, hormonal implant (Implanon), vaginal ring Intrauterine devices (IUDs): Cooper IUD (Loop), hormonal IUD (Mirena) Natural methods: Basic body temperature, ovulation period, coitus interrupts, abstinent Exclusion Criteria: Those with a skin disease (skin infection, eczema, psoriasis, rosacea, herpes etc.) in the lower 2/3 part of the face in which the wrinkle evaluation may be affected Patients who had been treated for a malignant tumor within 5 years prior to Visit 2 (randomization)* Women in pregnancy or lactation Those with the bilirubin level exceeding 1.5x of the upper limit of normal or the ALT/AST level exceeding 2.5x of the upper limit of normal Those with the confirmed infection of syphilis or HIV Those who had an anticoagulant therapy or antiplatelet therapy within 2 weeks prior to Visit 1 (screening) Those who used a topical preparation (steroid, retinoid) in the facial area within 4 weeks prior to Visit 2 (randomization) Those who experienced a deep chemical peeling or a laser procedure (including IPL) within 3 months prior to Visit 2 (randomization) Those who experienced a non-permanent filler procedure or a cosmetic surgery in the face within 9 months prior to Visit 2 (randomization) Those who had an implantation procedure with a permanent substance (silicone, PAAG, PMMA, CaHA etc.) in the treatment area (nasolabial fold ) Those currently with a streptococcal disease Those with a history of severe allergy or hypersensitivity (anaphylaxis) judged as potentially affecting the clinical study Those with a history of hypertrophic scar or keloid Those with a history of bleeding disorder Those with a hypersensitivity to the investigational medical device of this clinical study or lidocaine Those who refused to agree not to use a local or systemic pain-relieving agent or other pain-relieving method (e.g.: ice pack) from the midnight of the treatment day with the investigational medical device through the post-measurement of the last VAS pain scale Those who had participated in another clinical study within 1 month prior to Visit 1 (screening) Those judged by the investigator as ineligible for this clinical study * Excluded were the patients with treated basal cell or squamous cell skin cancer or treated cervical cancer, of which the location is not the lower 2/3 part of the face.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: split-face design study. Subjects were decided by randomization which side of the face would be injected with the test device. According to this randomization result, the other side would be determined to be injected with a comparator. It was determined just by one randomization.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HA IDF plus<br>cross-linked HA filler with lidocaine | Device: HA IDF plus<br> <br> |
| Active Comparator: HA IDF<br>cross-linked HA filler without lidocaine | Device: HA IDF<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of the Subjects With at Least 10mm Difference in VAS Pain Scale Scores Within the Subject (VAS of the Control Medical Device - VAS of the Test Medical Device) Immediately After Treatment With the Investigational Medical Devices | The degree of pain was evaluated by VAS (Visual Analog Scale), measuring the length from the left and to the mark by the subject in millimeter (mm) unit. | Visit 2 (week 0, immediately after treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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facial nasolabial fold wrinkles