Clinical trial: Correlation Study Between PEST and SCORAD in Management of Atopic Dermatitis With Ceradan® Regimen (NCT02073591)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 6 Years

Patient description (medical language): A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago.  A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy.  The patient has had a few upper respiratory infections but no major illnesses.  Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance.  Vital signs and milestone examination are within normal limits.  Similar findings are observed on the cheeks and proximal upper extremities.  The diaper area is clear, and no mucosal lesions are present.

Patient description (patient's own words): I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions.

Does the patient match the trial criteria? Entailment