Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
T&R.SkinP.01
Study information
Scientific title
Acronym
T&R.SkinP.01
Study hypothesis
Sodium cromoglicate lotion applied topically to the skin is more effective than the vehicle in the treatment of atopic dermatitis in children.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Atopic dermatitis
Intervention
Parallel group comparative randomised controlled trial:
1. 4% sodium cromoglicate in an aqueous lotion
2. The aqueous lotion vehicle
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The change in the SCORAD assessment score between end of baseline and after 12 weeks treatment.
Secondary outcome measures
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 Childrens Dermatology Life Quality Index (CDLQI) or Infant Life Quality Index
Overall trial start date
01/10/2005
Overall trial end date
30/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
174
Participant exclusion criteria
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
Recruitment start date
01/10/2005
Recruitment end date
30/06/2007
Locations
Countries of recruitment
Norway, United Kingdom
Trial participating centre
Voksentoppen BKL
Oslo
NO 0791
Norway
Sponsor information
Organisation
Thornton and Ross Ltd (UK)
Sponsor details
Stephen J Skilleter
Thornton & Ross Ltd
Linthwaite
Huddersfield
HD7 5QH
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Thornton and Ross Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/15727648
Publication citations
-
Results
Stainer R, Matthews S, Arshad SH, McDonald S, Robinson J, Schapira C, Foote KD, Baird-Snell M, Gregory T, Pollock I, Stevens MT, Edwards AM, Efficacy and acceptability of a new topical skin lotion of sodium cromoglicate (Altoderm) in atopic dermatitis in children aged 2-12 years: a double-blind, randomized, placebo-controlled trial., Br. J. Dermatol., 2005, 152, 2, 334-341, doi: 10.1111/j.1365-2133.2004.06303.x.