E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 4.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012438 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy, steroid-sparing properties, safety and acceptability of a topically applied new lotion formulation of sodium cromoglicate in the treatment of atopic dermatitis in children. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
At screening »Children of either sex aged between 1 and 16 years. »Children with atopic dermatitis according to criteria according to the UK Working Party for diagnostic criteria for atopic dermatitis [1]. These are: lMust have an itchy skin condition (or report of scratching or rubbing in a child). lPlus 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 »Children with atopic dermatitis who at the Screening Visit (Visit 1) and at Visit 2 exhibit a score using the SCORAD scoring system for atopic dermatitis of ≥25 [2] »Children of parents, one of whom gives signed, informed consent to participate in the trial.
At entry to double blind period »Children who, according to the European Task Force on Atopic Dermatitis [2] have a SCORAD score of ≥25 and scores for overall skin condition of 2 on at least 4 days of the 14 days of the baseline.
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E.4 | Principal exclusion criteria |
»Children with any chronic disease other than associated allergic diseases,( which include recurrent wheezing, allergic rhinitis and food allergy). »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 3 months.
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E.5 End points |
E.5.1 | Primary end point(s) |
»Change in SCORAD assessment scores »Change in overall skin condition, itching and sleep disturbance as recorded on the diary cards »Change in use of concomitant topical corticosteroids »Change in Children’s Dermatology Life Quality Index (CDLQI) or Infant Life Quality Index »Acceptability of treatment »Incidence of adverse events
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.1.7.1 | Other trial design description |
The second period of the trail is a open study. |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |