A trial of topical sodium cromoglicate in atopic dermatitis in children

INTERVENTION: Parallel group comparative randomised controlled trial: 1. 4% sodium cromoglicate in an aqueous lotion 2. The aqueous lotion vehicle CONDITION: Atopic dermatitis ; Skin and Connective Tissue Diseases ; Atopic dermatitis PRIMARY OUTCOME: The change in the SCORAD assessment score between end of baseline and after 12 weeks treatment. SECONDARY OUTCOME: 1. The change in overall skin condition, itch and sleep disturbance recorded on the daily diary cards; 2. The change in topical corticosteroid and/or immunomodulator drug use as recorded on the daily diary cards and by weighing of the tubes; 3. The global assessments recorded at the end of the study by the parent and investigator; 4. The change in Children?s Dermatology Life Quality Index (CDLQI) or Infant Life Quality Index INCLUSION CRITERIA: 1. Children of either sex aged between 1 and 12 years (after the first birthday and before the 13th birthday) 2. Children with atopic dermatitis according to the UK Working Party for diagnostic criteria for atopic dermatitis. These are: 2.1. Must have an itchy skin condition (or report of scratching or rubbing in a child) 2.2. Plus three or more of the following: 2.2.1. History of itchiness in skin creases such as folds of the elbows, behind the knees, fronts of ankles, or around the neck (or the cheeks in children less than 4 years) 2.2.2. History of asthma or hay fever (or history of atopic disease in a first degree relative in children under 4 years) 2.2.3. General dry skin in the past year 2.2.4. Visible flexural eczema (or eczema affecting the cheeks or forehead and outer limbs in children under 4 years) 2.2.5. Onset in the first two years of life 3. Children with atopic dermatitis who at the Screening Visit (Visit 1) and at Visit 2 e