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 at least 2 months since birth.
  • Modified SCORAD Index ≥ 10
  • Subjects whose biological mother or father, or one sibling has a well-documented history of atopy (AD, allergic rhinitis or asthma).

Inclusion criteria which must be verified during randomization (V2):

• Results of the RAST test for GP and HDM are available and IgE level against GP ≥ 0.35 kUA/l and / or IgE level against HDM ≥ 0.35 kUA/l.
• Safety laboratory results are within the normal range of the central laboratory or considered as not clinically significant or study disease related by the Investigator.

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 episode consisting of 3 (or more) consecutive nights resulting in sleep disturbances in a clinical setting where asthma is likely and other conditions have been excluded.
• Have chronic pulmonary diseases of any type, such as, but not limited to, cystic fibrosis, or any cranio-facial abnormality, e.g., cleft palate.
• Have a personal history of sleep apnea or who have siblings with a history of sleep apnea.
• 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 atopic dermatitis.
• 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) of inhaled/intranasal corticosteroids: 1 month,
• Ketotifen: 1 month,
• Astemizole: 6 weeks
• Have been treated with any antihistamine, including ketotifen, with daily intake for more 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.