Facial Rhytides
Conditions
Brief summary
This study will evaluate the inter-rater and intra-rater reliability of the Facial Wrinkle Scale with Asian Photonumeric Guide (FWS-A) in Japanese subjects.
Interventions
DRUGNo Intervention
No intervention.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Ability to assess facial lines in a mirror * Removal of facial jewelry and makeup for study visit
Exclusion criteria
* Infection or skin disorder affecting the face * Planned use of botulinum toxin of any serotype between Screening and Day 1 * Planned facial cosmetic procedure between Screening and Day 1 * Planned excessive/prolonged sun exposure between Screening and Day 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A) | 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. |
| Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A) | Day 1 | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants with facial lines. There was no intervention in this study. | 66 |
| Total | 66 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age Continuous | 52.5 Years |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 |
Outcome results
Primary
Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
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.
Time frame: Day 1
Population: Reliability population included all enrolled participants with at least 1 assessment by at least 1 live rater performed on day 1.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
Primary
Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)
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.
Time frame: Day 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |
| All Participants | 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 |