A Clinical Study to Evaluate the Efficacy and Safety of YVOIRE Classic Plus Versus YVOIRE Classic in Nasolabial Fold Injection
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
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
|
Outcome Measures
Primary Outcome Measures
- 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 [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.
Eligibility Criteria
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)
-
Natural methods: Basic body temperature, ovulation period, coitus interrupts, 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 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
-
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
-
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 * 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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- LG Life Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LG-HACL012
Study Results
Participant Flow
Recruitment Details | 62 subject in total in 2 institutions period : Feb 2014~ May 2015 |
---|---|
Pre-assignment Detail | spilt-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. |
Arm/Group Title | Subject Disposition |
---|---|
Arm/Group Description | All Study Participants |
Period Title: Overall Study | |
STARTED | 62 |
COMPLETED | 60 |
NOT COMPLETED | 2 |
Baseline Characteristics
Arm/Group Title | Demographic Charateristics |
---|---|
Arm/Group Description | Subjects who were included in efficacy evaluation |
Overall Participants | 62 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
43.71
(7.18)
|
Sex: Female, Male (Count of Participants) | |
Female |
62
100%
|
Male |
0
0%
|
Outcome Measures
Title | 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 |
---|---|
Description | 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. |
Time Frame | Visit 2 (week 0, immediately after treatment) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Subjects With at Least a 10mm Difference in VAS | Subjects With Below 10mm Difference in VAS |
---|---|---|
Arm/Group Description | Subjects with at least a 10mm difference in VAS (HA IDF II - HA IDF II plus) | Subjects with below 10mm difference in VAS (HA IDF II - HA IDF II plus) |
Measure Participants | 62 | 62 |
Number [participants] |
57
91.9%
|
5
NaN
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Subjects With at Least a 10mm Difference in VAS, Subjects With Below 10mm Difference in VAS |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Subjects % with difference in VAS ≥ 10mm |
Estimated Value | 0.9194 | |
Confidence Interval |
(2-Sided) 95% 0.80 to 0.97 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | The Safety set consisted of the subjects who were treated with the investigational device at least once after Visit 2 (Randomization) and had a safety follow-up at least once | |
---|---|---|
Adverse Event Reporting Description | The safety results were analyzed in the Safety set, and the safety was evaluated for the endpoints of local reactions, adverse events, vital signs and laboratory tests. | |
Arm/Group Title | Safety | |
Arm/Group Description | Subject who were injected with investigational medical device at least once. The 'Serious Adverse Events' and 'Other Adverse Events' described below occured in each subject regardless of the left or right of the injection site, and since all subjects were injected with both test device and comparator, it was not indicated which side the test device was injected. | |
All Cause Mortality |
||
Safety | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Safety | ||
Affected / at Risk (%) | # Events | |
Total | 1/62 (1.6%) | |
Infections and infestations | ||
nasopharyngitis | 1/62 (1.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||
Safety | ||
Affected / at Risk (%) | # Events | |
Total | 5/62 (8.1%) | |
Infections and infestations | ||
Bronchitis | 5/62 (8.1%) | 26 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
Name/Title | Study Leader |
---|---|
Organization | LG Chem |
Phone | 82-2-6987-4148 |
sodam@lgchem.com |
- LG-HACL012