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Completed

NCT Number: NCT02073591

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

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.

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Key information

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

KK Women's and Children's Hospital, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ceradan Cream

Other

Ceradan Wash

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. Efficacy by change in SCORAD score at Week 4 and Week 12 as compared to baseline

    Time frame: 12 weeks

  2. 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

Sponsors and collaborators

Lead sponsor

Hyphens Pharma Pte Ltd

Industry

Registry information

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

Acronym: COPES

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 27, 2014
Registry last updated
Nov 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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