Reliability of the Facial Wrinkle Scale in Japanese Subjects

Completed

• Conditions: Facial Rhytides
• Interventions: Drug: No Intervention

• Registration Number: NCT01600729
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-17
• Study Start: 2012-06
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2013-07-12
• Results First Submitted QC: 2013-07-12
• Status Verified: 2013-09
• Results First Posted: 2013-09-17
• Last Update Submitted: 2013-09-27
• Last Update Posted: 2013-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Ability to assess facial lines in a mirror
• Removal of facial jewelry and makeup for study visit

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Participants	No Intervention	Participants with facial lines. There was no intervention in this study.

Primary Outcome Measures

Name	Time	Method
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.