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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis
- Sponsor
- Hyphens Pharma Pte Ltd
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- 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)