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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceradan Regimen | Ceradan Cream and Ceradan Wash |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceradan Cream | Other |
| ||
| Ceradan Wash |
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy by change in SCORAD score at Week 4 and Week 12 as compared to baseline | 12 weeks | |
| Efficacy by change in AUC PEST score at Week 4, Week 12 as compared to baseline and three months prior to baseline | 12 weeks |
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Inclusion Criteria:
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
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Children Aged Six Months to Six Years with Atopic Dermatitis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's and Children's Hospital | Singapore | Singapore | ||||
| National Skin Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28616853 | Derived | Koh MJ, Giam YC, Liew HM, Foong AY, Chong JH, Wong SMY, Tang MBY, Ho MSL, Tan LS, Mason JM, Cork MJ. Comparison of the Simple Patient-Centric Atopic Dermatitis Scoring System PEST with SCORAD in Young Children Using a Ceramide Dominant Therapeutic Moisturizer. Dermatol Ther (Heidelb). 2017 Sep;7(3):383-393. doi: 10.1007/s13555-017-0186-1. Epub 2017 Jun 14. |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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|
| Singapore |
| Singapore |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |