Phase
Condition
Dermatitis, Atopic
Asthma
Allergy
Treatment
N/AClinical Study ID
Ages 12-24 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Inclusion criteria which must be verified during screening visit (V1):
Children of either sex aged between 12 and 24 months
Subjects suffering from symptoms of Atopic Dermatitis (AD) lasting cumulatively for atleast 2 months since birth
Modified Severity Scoring of Atopic Dermatitis (SCORAD) Index >= 10
Subjects whose biological mother or father, or one sibling has a well-documentedhistory of atopy (AD, allergic rhinitis or asthma) Inclusion criteria which must be verified during randomization (V2):
Results of the Radio-allergosorbant (RAST) test for grass pollen (GP) and house dustmite (HDM) are available and Immunoglobulin E (IgE) level against GP >= 0.35 kUA/land/or IgE level against HDM ≥ 0.35 kUA/l
Safety laboratory results are within the normal range of the central laboratory orconsidered as not clinically significant or study disease related by the Investigator
Exclusion
Exclusion Criteria: Exclusion criteria to verify at screening visit (V1): Are to be excluded from the participation in the study, those children who
Have height or weight below the 5th percentile
Have experienced at least one episode of wheezing when aged 6 months or over
Have suffered at age 6 months or over, from at least one nocturnal cough episodeconsisting of 3 (or more) consecutive nights resulting in sleep disturbances in aclinical setting where asthma is likely and other conditions have been excluded
Have chronic pulmonary diseases of any type, such as, but not limited to, cysticfibrosis, or any cranio-facial abnormality, e.g., cleft palate
Have a personal history of sleep apnea or who have siblings with a history of sleepapnea
Are treated with any immunomodulator medication such as, e.g., cyclosporin,cyclophosphamide or FK 506 (Tacrolimus)
Have received or are receiving allergen - specific immunotherapy
Suffer from concomitant dermatological disease/condition other than atopic dermatitis,that might interfere with the evaluation of the clinical response for atopicdermatitis
Have an insufficient wash-out period for the following medications:
Intranasal or systemic antihistamines: 3 days,
Intranasal or systemic decongestants: 3 days,
Loratadine, Desloratadine: 10 days,
Chromones: 2 weeks,
Oral corticosteroids: 1 month,
Chronic use (i.e. cumulatively up to 2 weeks within the last 3 months) ofinhaled/intranasal corticosteroids: 1 month,
Ketotifen: 1 month,
Astemizole: 6 weeks
Have been treated with any antihistamine, including ketotifen, with daily intake formore than 2 consecutive months in the last 6 months before screening Subject Exclusion criteria to verify at randomization visit (V2):
• Intake of any prohibited medication listed above during the selection period