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

LG Life Sciences0 sites62 target enrollmentFebruary 2014

ConditionsWrinkles

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Wrinkles
Sponsor: LG Life Sciences
Enrollment: 62
Primary Endpoint: 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
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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).

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.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

June 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

LG Life Sciences

Responsible Party

Sponsor

Eligibility Criteria

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 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)

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 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 )

Outcomes

Primary Outcomes

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

Time Frame: Visit 2 (week 0, immediately after treatment)

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.