Clinical Trial: Correlation Study Between PEST and SCORAD in Management of Atopic Dermatitis With Ceradan® Regimen

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Phase IV, Open Label, Single Arm, Multicenter, Observational Study to Evaluate the Correlation Between PEST and SCORAD Score in the Management of Atopic Dermatitis With

Brief Summary: This is a prospective, open label, single arm, and observational and multicenter study to assess the correlation between PEST and SCORAD scores in the management of AD with the Ceradan® regimen.

Detailed Summary:

All eligible patients shall apply permitted topical steroid(s) according to standard local practice

For the entire study period, patients should apply Ceradan Cream® liberally twice daily or more, if required and use a non-soap based wash once or twice daily.

At the screening visit, patients will receive a diary card and will be asked to track their atopic dermatitis symptoms for 12 weeks.

Retrospective information on other topical treatments used will be collected at baseline.


Sponsor: Hyphens Pharma Pte Ltd

Current Primary Outcome: Correlation between the mean Patient Eczema Severity Time (PEST) score and mean Scoring Atopic Dermatitis (SCORAD) Index at Week 4 and Week 12, as compared to baseline [ Time Frame: 12 weeks ]

Correlation will be assessed by Pearson correlation at baseline, Week 4 and Week 12 between both scores. Karl Pearson correlation coefficient (ρ) will be provided. Percent Change from Baseline will be calculated for Week 4 and Week 12 and correlation will also be calculated for it.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Efficacy by change in SCORAD score at Week 4 and Week 12 as compared to baseline [ Time Frame: 12 weeks ]
  • Efficacy by change in AUC PEST score at Week 4, Week 12 as compared to baseline and three months prior to baseline [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Hyphens Pharma Pte Ltd

Dates:
Date Received: February 19, 2014
Date Started: March 2014
Date Completion:
Last Updated: November 4, 2015
Last Verified: November 2015