Wrinkles
Conditions
Keywords
the facial nasolabial fold
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).
Interventions
DEVICEHA IDF II plus
DEVICEHA IDF II
Sponsors
LG Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged between 30 and 60 2. 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 3. Those who were informed on the purpose, method, and effect etc. of this study and signed the informed consent form 4. 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
1. 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 2. Patients with a malignant tumor recognized medically important and considered as potentially affecting the clinical study 3. Women in pregnancy or lactation 4. 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 5. Those with the confirmed infection of syphilis or HIV 6. Those who had an anticoagulant therapy or antiplatelet therapy within 2 weeks prior to Visit 1 (screening) 7. Those who used a topical preparation (steroid, retinoid) in the facial area within 4 weeks prior to Visit 2 (randomization ) 8. 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) 9. Those who experienced a non-permanent filler procedure or a cosmetic surgery in the face within 9 months prior to Visit 2 (randomization) 10. Those who had an implantation procedure with a permanent substance (silicone, PAAG, PMMA, CaHA etc.) in the treatment area (nasolabial fold ) 11. Those currently with a streptococcal disease 12. Those with a history of severe allergy or hypersensitivity (anaphylaxis) judged as potentially affecting the clinical study 13. Those with a history of hypertrophic scar or keloid 14. Those with a history of bleeding disorder 15. Those with a hypersensitivity to the investigational device of this clinical study or lidocaine 16. 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 17. Those who had participated in another clinical study within 1 month prior to Visit 1 (screening) 18. Those judged by the investigator as ineligible for this clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Participant flow
Recruitment details
at 2 hospitals in korea, 62 patients. period : Nov 2013\ Feb 2015
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Demographic Charateristics Subjects who were included in efficacy evaluation | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Demographic Charateristics |
|---|---|
| Age, Continuous | 46.39 years STANDARD_DEVIATION 7.03 |
| Sex/Gender, Customized Female | 62 participants |
| Sex/Gender, Customized Male | 0 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
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.
Time frame: Visit 2 (week 0, immediately after treatment)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects With at Least a 10mm Difference in VAS | 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 | 59 participants |
| Subjects With Below 10mm Difference in VAS | 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 | 3 participants |
95% CI: [0.87, 0.99]