Paediatric atopic dermatitis MedDRA version: 14.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Altoderm
Pharmaceutical Form: Cutaneous emulsion
INN or Proposed INN: Sodium cromoglicate
CAS Number: 15826-37-6
Concentra
Sponsors
Thornton & Ross Limited
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of topically applied Altoderm in the treatment of atopic dermatitis in children.;Secondary Objective: ; Primary end point(s): Total SCORAD The total SCORAD will be summarised and analysed using the change from the end of baseline (Visit 3 assessment) at each subsequent assessment to show the trend with time. For this analysis the last observation will be carried forward for patients with incomplete data. The primary time-point for assessment of efficacy will be the Week 12 comparison (corresponding to the last observation carried forward (LOCF) method). An analysis of covariance will be used at each time-point, including treatment and centre as main effects and baseline (Visit 3) as a covariate. Treatment x centre interaction will be included in the model but dropped if not statistically significant (p>0.05). The adjusted mean difference between treatments at each time-point will be presented together with 95% confidence intervals for the difference. SCORAD – Itch (Pruritus) The skin itch component of Part C of the SCORAD assessment will be analysed using the same methods as detailed for the total SCORAD. | — |
Countries
United Kingdom
Contacts
Public ContactSponsor
Thornton & Ross Ltd
Outcome results
None listed