Trial Outcomes & Findings for Reliability of the Facial Wrinkle Scale in Japanese Subjects (NCT NCT01600729)
NCT ID: NCT01600729
Last Updated: 2013-09-30
Results Overview
Inter-rater (among raters) agreement of the FWS-A scores (0= none; 1= mild; 2= moderate; 3= severe) was evaluated by Kappa statistics. Kappa statistics were calculated for each of 7 raters who evaluated 66 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale. The overall inter-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was predefined as: ≤ 0= poor, 0.00-0.20= slight, 0.21-0.40= fair, 0.41-0.60= moderate, 0.61-0.80= substantial and 0.81-1.00= almost perfect. The 95% confidence interval for Kappa statistics was provided.
COMPLETED
66 participants
Day 1
2013-09-30
Participant Flow
Participant milestones
| Measure |
All Participants
Participants with facial lines. There was no intervention in this study.
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reliability of the Facial Wrinkle Scale in Japanese Subjects
Baseline characteristics by cohort
| Measure |
All Participants
n=66 Participants
Participants with facial lines. There was no intervention in this study.
|
|---|---|
|
Age Continuous
|
52.5 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Reliability population included all enrolled participants with at least 1 assessment by at least 1 live rater performed on day 1.
Inter-rater (among raters) agreement of the FWS-A scores (0= none; 1= mild; 2= moderate; 3= severe) was evaluated by Kappa statistics. Kappa statistics were calculated for each of 7 raters who evaluated 66 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale. The overall inter-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was predefined as: ≤ 0= poor, 0.00-0.20= slight, 0.21-0.40= fair, 0.41-0.60= moderate, 0.61-0.80= substantial and 0.81-1.00= almost perfect. The 95% confidence interval for Kappa statistics was provided.
Outcome measures
| Measure |
All Participants
n=66 Participants
Participants with facial lines. There was no intervention in this study.
|
|---|---|
|
Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Forehead Lines at Rest
|
0.653 Kappa statistics
Interval 0.621 to 0.684
|
|
Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Glabellar Lines at Rest
|
0.637 Kappa statistics
Interval 0.607 to 0.668
|
|
Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Crow's Feet Left Side at Rest
|
0.647 Kappa statistics
Interval 0.616 to 0.678
|
|
Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Crow's Feet Right Side at Rest
|
0.654 Kappa statistics
Interval 0.623 to 0.685
|
|
Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Forehead Lines at Maximum Brow Elevation
|
0.527 Kappa statistics
Interval 0.495 to 0.56
|
|
Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Glabellar Lines at Maximum Frown
|
0.507 Kappa statistics
Interval 0.473 to 0.54
|
|
Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Crow's Feet Left Side at Maximum Smile
|
0.641 Kappa statistics
Interval 0.61 to 0.671
|
|
Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Crow's Feet Right Side at Maximum Smile
|
0.622 Kappa statistics
Interval 0.592 to 0.653
|
PRIMARY outcome
Timeframe: Day 1Population: Participants from the Reliability population (all enrolled participants with at least 1 assessment by at least 1 live rater performed on day 1) who had 2 assessments on Day 1 available for analysis.
Intra-rater (within raters) agreement of the FWS-A scores (0=none; 1=mild; 2=moderate; 3=severe) was evaluated by weighted Kappa statistics (WKS). WKS were calculated for each of 7 raters who evaluated 65 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale at 2 different time-points on Day 1. The overall intra-rater agreement for WKS for all raters combined was estimated by pooling WKS for each rater using a chi-square statistic. The degree of agreement of the point estimates of WKS was interpreted according to the reference range scale that was predefined as: ≤0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for WKS was provided.
Outcome measures
| Measure |
All Participants
n=65 Participants
Participants with facial lines. There was no intervention in this study.
|
|---|---|
|
Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Forehead Lines at Rest
|
0.886 Kappa statistics
Interval 0.858 to 0.914
|
|
Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Glabellar Lines at Rest
|
0.861 Kappa statistics
Interval 0.832 to 0.89
|
|
Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Crow's Feet Left Side at Rest
|
0.841 Kappa statistics
Interval 0.809 to 0.872
|
|
Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Crow's Feet Right Side at Rest
|
0.838 Kappa statistics
Interval 0.806 to 0.869
|
|
Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Forehead Lines at Maximum Brow Elevation
|
0.810 Kappa statistics
Interval 0.775 to 0.846
|
|
Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Glabellar Lines at Maximum Frown
|
0.770 Kappa statistics
Interval 0.731 to 0.808
|
|
Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Crow's Feet Left Side at Maximum Smile
|
0.836 Kappa statistics
Interval 0.804 to 0.867
|
|
Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
Crow's Feet Right Side at Maximum Smile
|
0.832 Kappa statistics
Interval 0.8 to 0.864
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER