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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01636765
Other study ID # 199201-003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2012
Est. completion date July 2012

Study information

Verified date November 2019
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a study to evaluate inter- and intra-rater reliability of the Clinician Erythema Assessment Scale. There is no treatment (intervention) associated with this study.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Rosacea

Exclusion Criteria:

- Unwilling to remove all facial make-up

Study Design


Related Conditions & MeSH terms


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

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inter-rater Reliability of the Clinician Erythema Assessment (CEA) Scale Inter-rater agreement (among raters) of the CEA scores (0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness; 4=severe erythema, fiery redness) evaluated using Kendall's coefficient of concordance (Kendall's W). Each of 7 raters scored 104 participant's severity of erythema due to rosacea using the CEA 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=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 Kendall's W was provided. Day 1
Primary Intra-rater Reliability of the CEA Scale Intra-rater (within raters) agreement of the CEA scores (0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness; 4=severe erythema, fiery redness) was evaluated by weighted Kappa statistics (WKS). WKS were calculated for each of 7 raters who evaluated 104 participant's severity of erythema of rosacea using the CEA scale, assessing agreement between 2 different time points at 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 Kappa statistics was provided. Day 1
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