A Clinical Study to Evaluate the Efficacy and Safety of YVOIRE Volume Plus Versus YVOIRE Volume 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 II plus (with lidocaine) injected in the nasolabial fold compared to HA IDF II (without lidocaine).

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 II Plus Versus HA IDF II in Nasolabial Fold Injection

Conditions
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Wrinkles

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


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 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 interruptus, 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 with a malignant tumor recognized medically important and considered as potentially affecting the clinical study Women in pregnancy or lactation Those with the bilirubin level exceeding 1.5 times of the upper limit of normal or the ALT/AST level exceeding 2.5 times 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 procedure judged as potentially affecting the clinical study 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 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 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

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. 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HA IDF II<br>cross-linked HA filler | Device: HA IDF II<br> <br> |
| Experimental: HA IDF II plus<br>cross-linked HA filler with lidocaine | Device: HA IDF II plus<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 Device - VAS of the Test Device) Immediately After Treatment With the Investigational 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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the facial nasolabial fold