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 ]
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