Reliability of the Facial Wrinkle Scale in Japanese Subjects

NCT01600729 | Completed Results

• 1 other identifier: 191622-119
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Rhytides

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

All Participants

Participants with facial lines. There was no intervention in this study.

Drug: No Intervention

Interventions

No Intervention DRUG

No intervention.

All Participants

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with facial lines

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: May 17, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 30, 2013
• Results First Posted: September 17, 2013

Record last verified: 2013-09

Locations

JP (1)