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ISRCTN
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ISRCTN43865436
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ClinicalTrials.gov identifier
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Public title
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A trial of topical sodium cromoglicate in atopic dermatitis in children
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Scientific title
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Acronym
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T&R.SkinP.01
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Serial number at source
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T&R.SkinP.01
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Study hypothesis
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Sodium cromoglicate lotion applied topically to the skin is more effective than the vehicle in the treatment of atopic dermatitis in children.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Norway, United Kingdom
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Disease/condition/study domain
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Atopic dermatitis
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Participants - inclusion criteria
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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 exhibit a score using the SCORing Atopic Dermatitis (SCORAD) scoring system for atopic dermatitis of greater than or equal to 25
4. Children of parents, one of whom gives signed, informed consent to participate in the trial
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Participants - exclusion criteria
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1. Children with any chronic disease other than associated allergic diseases (which include recurrent wheezing, allergic rhinitis and food allergy)
2. Children who have cardiovascular, neurological, hepatic, renal, gastrointestinal, or other significant acute or chronic medical indication which, in the judgement of the investigator, might interfere with the study or require treatment
3. Patients who have received oral corticosteroids or corticosteroids by injection within the past 3 months
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Anticipated start date
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01/10/2005
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Anticipated end date
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30/06/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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174
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Interventions
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Parallel group comparative randomised controlled trial:
1. 4% sodium cromoglicate in an aqueous lotion
2. The aqueous lotion vehicle
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Primary outcome measure(s)
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The change in the SCORAD assessment score between end of baseline and after 12 weeks treatment.
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Secondary outcome measure(s)
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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
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Sources of funding
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Thornton and Ross Ltd (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/15727648
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Contact name
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Prof
Kai-Håkon
Carlsen
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Address
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Voksentoppen BKL
National Hospital (Rikshoapitalet)
Ullveien14
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City/town
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Oslo
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Zip/Postcode
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NO 0791
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Country
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Norway
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Sponsor
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Thornton and Ross Ltd (UK)
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Address
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Stephen J Skilleter
Thornton & Ross Ltd
Linthwaite
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City/town
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Huddersfield
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Zip/Postcode
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HD7 5QH
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Country
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United Kingdom
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Sponsor website:
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http://www.thorntonross.com
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Date applied
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14/09/2005
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Last edited
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14/08/2008
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Date ISRCTN assigned
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12/10/2005
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