Atopic dermatitis (eczema) Skin and Connective Tissue Diseases Allergic contact dermatitis
Conditions
Interventions
Active: a 4% solution of sodium cromoglicate in an aqueous lotion base
Control: the aqueous lotion base (vehicle)
Both treatments are applied to the affected areas of skin, twice daily. The total int
the total trial period is 16 weeks. There is a 4 week baseline period when all continue with existing treatment which must include an emollient. There is no follow-on period.
Sponsors
Thornton & Ross Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At screening: 1. Children of either sex aged over 2 years but less than 12 years (after 2nd birthday and before 12th birthday) 2. Children with atopic dermatitis according to criteria of 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. 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 who have a SCORing Atopic Dermatitis (SCORAD) of greater than or equal to 25 and less than or equal to 60 4. Children with atopic dermatitis whose parent(s) agree to: 4.1. Keep daily diary cards throughout the 16 weeks of the study, in order to record: 4.1.1. The weight and number of times, each day, they use their emollients and topical steroids during the baseline and emollients, topical steroids and test medication during the double-blind period 4.1.2. The child's eczema (skin condition, itching and sleep disturbance on a 4 point scale) 4.2. Ensure that their emollient is applied at least twice daily throughout the baseline period (weeks 1 - 4) but only as required during the double blind period (weeks 5 - 16) 5. Children who are able, in the investigator's opinion, to understand the issues, give signed, informed consent to participate in the trial 6. Children of parents (or legal guardians) who give signed, informed consent to participate in the trial At entry to double blind period: Children who, having been treated with emollients on a regular basis for 4 weeks (baseline period), have a SCORAD of greater than or equal to 25 and less than or equal to 60 and diary card scores for skin itch and overall skin condition of 2 or greater (using a 0 - 3 scale), on at least 4 days of the last 14 days of the baseline period.
Exclusion criteria
Exclusion criteria: 1. Children with any other chronic disease with the exception of those associated allergic diseases (such as recurrent wheezing, allergic rhinitis and food allergy) should be excluded 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 required treatment 3. Patients who have received oral corticosteroids or corticosteroids by injection within the past 2 months 4. Patients currently using wet wrapping or calcineurin immunomodulators or have used wet wrapping during the previous 7 days or calcineurin immunomodulators during the previous 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in SCORAD score and in the skin itch element of the SCORAD score at the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in Six Area, Six Sign Atopic Dermatitis (SASSAD) score, estimated at each clinic visit, 7 times in total 2. Change from baseline in severity of overall skin condition, skin itch and sleep disturbance as measured on a daily diary card, recorded daily by the parent throughout the baseline and treatment period and analysed in 2 week blocks 3. Change from baseline in usage of topical steroid therapy as determined by daily use as recorded on diary cards (proportion of days used and times used per day), and weight of topical steroid used, recorded daily by the parent and amount used weighed and recorded each day. The results will be analysed in 2 week blocks. 4. Change from baseline in steroid use as recorded by Investigator at each clinic visit, recorded daily by the parent and amount used weighed and recorded each day. The results will be analysed in 2 week blocks. 5. Change from baseline in quality of life questionnaire using the Children's Dermatology Life Quality Index (CDLQI) or Infant's Dermatitis Quality of Life Index (IDQOL), completed at visits 1, 3, 5 and 7 6. Global opinions (parent and investigator) of efficacy of treatment and acceptability, recorded at the final clinic visit 7. Incidence of adverse events | — |
Countries
United Kingdom
Outcome results
None listed