EUCTR2008-005469-67-GBActive, not recruitingPhase 1
A multi-centre, double-blind, vehicle-controlled, randomised group-comparative study to evaluate the efficacy and safety of Altoderm, a topically applied sodium cromoglicate lotion, in the treatment of atopic dermatitis in children.
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Thornton & Ross Limited
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility 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 dermatitis2. These are:
- •a) Must have an itchy skin condition (or report of scratching or rubbing in a child).
- •b) Plus three or more of the following:
- •- 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)
- •- History of asthma or hay fever (or history of atopic disease in a first degree relative in children under 4 years)
- •- General dry skin in the past year
- •- Visible flexural eczema (or eczema affecting the cheeks or forehead and outer limbs in children under 4 years)
- •- Onset in the first two years of life
- •3. Children who have a SCORAD of =25 and =60
- •4. Children with atopic dermatitis whose parent(s) agree to
- •a) keep daily diary cards throughout the 16 weeks of the study, in order to record:
- •- 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.
- •- the child’s eczema (skin condition, itching and sleep disturbance on a 4 point scale)
- •b) 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 =25 and =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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •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.
- •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.
- •Patients who have received oral corticosteroids or corticosteroids by injection within the past 2 months.
- •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.
Investigators
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