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

LG Life Sciences

Status

Completed

Conditions

Wrinkles

Treatments

Device: HA IDF II plus

Device: HA IDF II

Study type

Interventional

Funder types

Industry

Identifiers

NCT02340078

LG-HACL011

Details and patient eligibility

About

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).

Enrollment

62 patients

Sex

Female

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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:
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 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