Trial Outcomes & Findings for A Clinical Study to Evaluate the Efficacy and Safety of YVOIRE Classic Plus Versus YVOIRE Classic in Nasolabial Fold Injection (NCT NCT02340091)
NCT ID: NCT02340091
Last Updated: 2019-01-23
Results Overview
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.
COMPLETED
NA
62 participants
Visit 2 (week 0, immediately after treatment)
2019-01-23
Participant Flow
62 subject in total in 2 institutions period : Feb 2014\~ May 2015
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.
Participant milestones
| Measure |
Subject Disposition
All Study Participants
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study to Evaluate the Efficacy and Safety of YVOIRE Classic Plus Versus YVOIRE Classic in Nasolabial Fold Injection
Baseline characteristics by cohort
| Measure |
Demographic Charateristics
n=62 Participants
Subjects who were included in efficacy evaluation
|
|---|---|
|
Age, Continuous
|
43.71 years
STANDARD_DEVIATION 7.18 • n=93 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Subjects With at Least a 10mm Difference in VAS
n=62 Participants
Subjects with at least a 10mm difference in VAS (HA IDF II - HA IDF II plus)
|
Subjects With Below 10mm Difference in VAS
n=62 Participants
Subjects with below 10mm difference in VAS (HA IDF II - HA IDF II plus)
|
|---|---|---|
|
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
|
57 participants
|
5 participants
|
Adverse Events
Safety
Serious adverse events
| Measure |
Safety
n=62 participants at risk
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.
|
|---|---|
|
Infections and infestations
nasopharyngitis
|
1.6%
1/62 • Number of events 1 • 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
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.
|
Other adverse events
| Measure |
Safety
n=62 participants at risk
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.
|
|---|---|
|
Infections and infestations
Bronchitis
|
8.1%
5/62 • Number of events 26 • 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
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER