E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
To compare the efficacy of E45 complete emollient therapy against an unchanged emollient regime along with the role of E45 anti itch cream in controlling itch. This will be evaluated through validated quality of life questionnaires, investigators global assessment and diary cards. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to compare the tolerability of an E45 regime and the itch cream against an unchanged emollient regime. This will be evaluated through the collection of adverse events and a patient satisfaction questionnaire. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Only patients to whom all of the following conditions apply will be included: 1. Age: 2-16 years of age 2. Sex: male and female 3. Primary diagnosis: A diagnosis of atopic eczema as defined by the UK working party criteria and confirmed by a general practitioner 4. Patients who are using one of the top ten emollients (excluding lauromacrogols) listed in the BNF (see Appendix VI). 5. Status: patients at an enrolled site whose diagnosis of atopic eczema is defined as mild to moderate by the Rajka and Langeland criteria (1989) (a score of 3 - 7.5) and for whom their IGA does not >/ = 3 6. Patients who have a body surface area of at least 2% affected by atopic eczema. 7. Patients for whom the adult with parental responsibility has given written informed consent and for who have themselves given concurrent assent. |
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E.4 | Principal exclusion criteria |
Patients to whom any of the following conditions apply must be excluded: 1. Patients who are pregnant or breast feeding. 2. Patients who have used topical treatments other than emollients for the treatment of their atopic dermatitis in the last 3 days prior to consent (this includes but is not limited to all topical steroid preparations, Protopic, Elidel, antibioitics) 3. Patients who have used any light or systemic treatments (including anti histamines) for the treatment of their atopic dermatitis in the past 28 days prior to consent. 4. Patients who are using or have used in the past 28 days prior to consent systemic corticosteroids for the treatment of any disease. 5. Patients who currently have or are suspected of previously having any disease (dermatological or other) that may interfere with the study protocol. 6. Those previously randomised into the study. 7. Those who have participated in a clinical trial in the previous 12 weeks prior to consent. 8. Patients who are using, intend to use or have used in the preceding 4 weeks prior to consent any alternative, homeopathic treatments. 9. Any previous history of allergy or known intolerance to any of the drugs or formulation constituents 10. Those unable in the opinion of the Investigator to comply fully with the study requirements. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The study will look at two primary efficacy endpoints. The first, to assess the overall efficacy of the E45 emollient therapy regime, is the change in validated quality of life score (children’s dermatology life quality index (CDLQI)) from baseline to week 6, comparing treatment groups A and C. The second, to assess the efficacy of the E45 itch relief cream, is the cumulative change in the itch-severity visual analogue scale over the course of the study, comparing treatment groups A and B. Secondary efficacy endpoints include: · changes in the quality of life score at weeks 1 and 3 · changes in the itch visual analogue scale by week · changes in the dermatitis family impact questionnaire · changes in the IGA · changes in the itch 4-point grading scale · changes in the subjective global assessment (SGA) · the number of eczema flares recorded (defined as an IGA > or = 3)
Safety endpoints will include the incidence of all adverse events, serious adverse events, and treatment-related 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 | No |
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 | No |
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 | Yes |
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 | No |
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 |
Emollient/s (not containing lauromacrogols) listed in the BNF |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
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 | No |
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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The end of the study is defined as the last visit of the last subject undergoing the study. Reckitt Benckiser will notify the regulatory authority and ethics committee within 90 days of the end of the study (within 15 days if the study is ended prematurely).
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |