E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Children aged 1-15 years with Atopic Dermatitis |
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MedDRA Classification |
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 |
The main objective of this trial is to see whether covering discrete patches of atopic dermatitis with op site occlusive dressing results in a more rapid resolution in the patches of atopic dermatitis without causing an increase in side effects such as redness, itching and irritation.
The primary outcome measure will be the three item severity score (TIS) measured at each hospital visit. This is based on the evaluation of erythema, oedema/papulation and excoriation each on a scale of 0-3 (0=absent, 1=mild, 2=moderate and 3=severe). Therefore, the range of TIS therefore lies between 0 and 9. Scores from 1-3 will be categorised as mild, 4-6 as moderate and 7-9 as severe. If the score is zero then there is no detectable lesion. The TIS score will be measured on days one, four and eight. The differences between the scores in both arms of the trial at the different stages will be analysed.
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E.2.2 | Secondary objectives of the trial |
Secondary Outcomes The size of the patch (maximum width and length) will be recorded at each clinic visit. Parents will be asked to record any side effects or problems they have faced and inform us after the final assessment. The families will also be asked about compliance with instructions. The lesions on both sides will be photographed with a scale marker.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The children should have AD as defined above. They should have small active patches, requiring treatment with topical corticosteroids on both sides of the body. |
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E.4 | Principal exclusion criteria |
Children with dermatitis covering an area larger than the occlusive dressing will be excluded. Children with known sensitivities to the study treatments, evidence of infected or bleeding AD or AD that is confined to the face or napkin area will also be excluded. Children who had received either oral steroid treatment, applied topical steroids to the study area or used alternative remedies will be excluded (16). Children less than one year old will be excluded as more potent corticosteroids are contraindicated for children less than one year (5). |
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E.5 End points |
E.5.1 | Primary end point(s) |
The children will apply the steriod cream and occlusion for 3 days only they will then be reviewed on day 4 and day 8, they will then be seen at their routine outpatient appointments. |
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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 | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Within patient single blinded randomised control trial |
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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 |
Same medicinal product without occlusion |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |