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

NCT02340091 | Completed Results

• 1 other identifier: LG-HACL012
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Wrinkles

Keywords

facial nasolabial fold wrinkles

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

HA IDF plus

EXPERIMENTAL

cross-linked HA filler with lidocaine

Device: HA IDF plus

HA IDF

ACTIVE COMPARATOR

cross-linked HA filler without lidocaine

Device: HA IDF

Interventions

HA IDF plus DEVICE

HA IDF plus

HA IDF DEVICE

HA IDF

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Life Sciences: lead

Results Point of Contact

• Title: Study Leader
• Organization: LG Chem

sodam@lgchem.com

82-2-6987-4148

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 16, 2015
• Study Start: February 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2015
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2015-01