Reliability of the Facial Wrinkle Scale in Japanese Subjects

Facial Rhytides Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600729
• Other study ID #: 191622-119
• Status: Completed
• Phase: N/A
• First received: May 15, 2012
• Last updated: September 27, 2013
• Start date: June 2012
• Est. completion date: July 2012

Study information

• Verified date: September 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Facial Rhytides

Intervention

Drug:
• No Intervention
No intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 1	No
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.	Day 1	No