Correlation Study Between PEST and SCORAD in Management of Atopic Dermatitis With Ceradan® Regimen (COPES)

November 4, 2015 updated by: Hyphens Pharma Pte Ltd

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 Use of Ceradan® Regimen in Children Aged Six Months to Six Years

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • KK Women's and Children's Hospital
      • Singapore, Singapore
        • National Skin Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children Aged Six Months to Six Years with Atopic Dermatitis

Description

Inclusion Criteria:

  • Male and female children aged ≥6 months to ≤6 years
  • Baseline PEST score of 3- 4
  • Diagnosis of mild to moderate atopic dermatitis, with grading of 3 to11, as per the NESS
  • Diagnosis of current flare (increased dryness, itching, redness, swelling and general irritability) at baseline visit according to Investigator's judgement
  • Patients who have not visited the dermatologist before (dermatologist-naïve)
  • Agree to participate and provide written consent by parent or guardian (and assent if applicable)

Exclusion Criteria:

  • History of severe episodes of atopic dermatitis (for example: oozing, crusts)
  • Clinical signs of skin infection (viral, bacterial or fungal)
  • Grading of >11 as defined by the Nottingham Eczema Severity Score (NESS) within 3 months prior to study inclusion
  • Known reaction or allergy to test drug or excipients or steroids
  • History of cutaneous or systemic viral (including HIV or AIDS), cutaneous mycotic or cutaneous bacterial disease requiring a topical or systemic therapy during the study period
  • Patients who are receiving any investigational drug or who have taken part in a clinical study with an investigational drug within three months prior to the start of study treatment

  • The patient has been exposed to below therapy within the set timeframe:

    i. Systemic administration of corticosteroid - four weeks; ii. Systemic administration of immunosuppressive drugs - four weeks; iii. UV therapy four weeks

  • Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
  • Parents/guardians may be unable to complete the patient diaries or questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ceradan Regimen
Ceradan Cream and Ceradan Wash
Other: Ceradan Cream
Other: Ceradan Wash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy by change in SCORAD score at Week 4 and Week 12 as compared to baseline
Time Frame: 12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyphens Pharma Pte Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimate)

February 27, 2014

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYP2013/001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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