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

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

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).

Study Overview

• Status: Completed
• Conditions: Wrinkles
• Intervention / Treatment: Device: HA IDF plus; Device: HA IDF

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women aged between 30 and 60
2. 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
3. Those who were informed on the purpose, method, and effect etc. of this study and signed the informed consent form

4. Those who fell under any of the following 3 cases:

   1. Surgically sterile women
   2. Women in menopause over 2 years from the last menstruation, aged at least 45

   3. 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:

1. 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
2. Patients who had been treated for a malignant tumor within 5 years prior to Visit 2 (randomization)*
3. Women in pregnancy or lactation
4. 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
5. Those with the confirmed infection of syphilis or HIV
6. Those who had an anticoagulant therapy or antiplatelet therapy within 2 weeks prior to Visit 1 (screening)
7. Those who used a topical preparation (steroid, retinoid) in the facial area within 4 weeks prior to Visit 2 (randomization)
8. Those who experienced a deep chemical peeling or a laser procedure (including IPL) within 3 months prior to Visit 2 (randomization)
9. Those who experienced a non-permanent filler procedure or a cosmetic surgery in the face within 9 months prior to Visit 2 (randomization)
10. Those who had an implantation procedure with a permanent substance (silicone, PAAG, PMMA, CaHA etc.) in the treatment area (nasolabial fold )
11. Those currently with a streptococcal disease
12. Those with a history of severe allergy or hypersensitivity (anaphylaxis) judged as potentially affecting the clinical study
13. Those with a history of hypertrophic scar or keloid
14. Those with a history of bleeding disorder
15. Those with a hypersensitivity to the investigational medical device of this clinical study or lidocaine
16. 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
17. Those who had participated in another clinical study within 1 month prior to Visit 1 (screening)
18. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: LG Life Sciences

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 13, 2015
• First Submitted That Met QC Criteria: January 15, 2015
• First Posted (Estimate): January 16, 2015

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 3, 2019
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: facial nasolabial fold wrinkles
• Other Study ID Numbers: LG-HACL012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No