Inter-rater and Intra-rater Reliability of the Global Eyebrow Assessment Scale

NCT01412086 | Completed Results

• 1 other identifier: 192024-068
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the inter- and intra-rater reliability of the GEBA Scale with photonumeric guide for the assessment of overall eyebrow fullness. There is no treatment (intervention) associated with this study.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Inter-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale

  Inter-rater agreement (among raters) of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated using Kendall's coefficient of concordance (Kendall's W). Each of 7 raters scored 112 subjects' eyebrows using the GEBA Scale at 2 different time points at day 1. The overall inter-rater agreement for Kendall's W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: ≤ 0: poor, 0.00-0.20: slightly, 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 Kendall's W was provided.

  Day 1

• Intra-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale

  Intra-rater (within raters) agreement of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated by weighted Kappa statistics. Weighted Kappa statistics were calculated for each of 7 raters who evaluated 112 subjects using GEBA scale, assessing agreement between 2 different time points at day 1. The overall intra-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: slightly, 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

Study Arms (1)

All Participants

Healthy volunteers. No treatment (intervention) was received.

Drug: No Intervention

Interventions

No Intervention DRUG

No Intervention.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

You may qualify if:

• Willing to remove makeup and jewelry at each visit
• Willing to have photographs taken of the facial area

You may not qualify if:

• Permanent eyebrow makeup (i.e., tattooing) or eyebrow implants of any kind
• Eyebrow extension application within 3 months of study entry
• Eyebrow tint or dye application within 2 months of study entry
• Eyebrow grooming (i.e., tweezing, waxing, or threading) between visits that is not part of the current routine

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Newport Beach, California, United States

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: August 5, 2011
• First Posted: August 9, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 29, 2012
• Results First Posted: October 29, 2012

Record last verified: 2012-09

Locations

US (1)