Correlation Study Between PEST and SCORAD in Management of Atopic Dermatitis With Ceradan® Regimen (NCT02073591) | Clinical Trial Compass
CompletedNot Applicable
Correlation Study Between PEST and SCORAD in Management of Atopic Dermatitis With Ceradan® Regimen
Singapore58 participantsStarted 2014-03
Plain-language 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.
Who can participate
Age range6 Months – 6 Years
SexALL
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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-naĂŻve)
* 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 …
What they're measuring
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