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

NCT02340078 | Completed Results

• 1 other identifier: LG-HACL011
• 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 II plus (with lidocaine) injected in the nasolabial fold compared to HA IDF II (without lidocaine).

Conditions

Wrinkles

Keywords

the facial nasolabial fold

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 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)

Study Arms (2)

HA IDF II

ACTIVE COMPARATOR

cross-linked HA filler

Device: HA IDF II

HA IDF II plus

EXPERIMENTAL

cross-linked HA filler with lidocaine

Device: HA IDF II plus

Interventions

HA IDF II plus DEVICE

HA IDF II plus

HA IDF II DEVICE

HA IDF II

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 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

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 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

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 16, 2015
• Study Start: November 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2013-11