E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
A dry skin disease characterized by areas of severe itching, redness, scaling, and loss of the surface of the skin (excoriation). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 |
The purpose of the study is to obtain patients’ feedback on the product’s cosmetic acceptability and performance/usefulness when used as part of normal standard care for the intended patient group. The additional, exploratory objectives are to assess the cosmetic acceptability and performance/usefulness of the gel in comparison to previous emollients if the patients have used an emollient within the previous year. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female patients, 2 years of age and upwards, presenting to their GP with atopic dermatitis requiring regular emollient treatment, either alone or as an adjunct to other topical pharmacotherapy will be eligible to take part in the study. |
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E.4 | Principal exclusion criteria |
Patients falling into any of the following categories will not be eligible to take part in the study: i) Less than 2 years old. ii) Acute, weeping or infected dermatoses. iii) Dermatoses considered by the investigator likely to require treatment with antibiotics or immunosuppressants within the next 2 weeks. iv) Other dry skin condition such as contact dermatitis or psoriasis. v) A history of known or suspected intolerance or skin sensitivity to products administered topically, whether cosmetics, toiletries or pharmaceuticals, unless such is known to be attributed to ingredients not present in the study emollient. vi) Having received any unlicensed drug within the last 30 days or scheduled to receive an investigative drug other than the study medication during the period of the study. vii) Systemic diseases which, in the opinion of the investigator, may adversely influence participation in the trial. viii) Use of oral steroids, immunosuppressants or antibiotics to treat their skin condition within the last 14 days. ix) Females who are pregnant or lactating (although there are no particular safety concerns for DELP in these patient groups, it is generally inappropriate for them to participate in clinical trials without overriding justification). x) Considered unable or unlikely to attend the necessary follow-up consultation. xi) Considered unlikely to understand the patient information leaflet which is to be written only in English. xii) Having another member of the household already participating in the study (because they may end up using the same pack of emollient or inadvertently swapping packs in which case estimates of the quantities used by each subject would be unreliable). |
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E.5 End points |
E.5.1 | Primary end point(s) |
There will be no primary outcome measure as such. The endpoints for the study are the patients' assessment of; i) the cosmetic acceptability of DELP (4 parameters) ii) the performance/usefulness of DELP (8 parameters) For those patients who have used prescribed emollients previously for their atopic dermatitis, additional exploratory endpoints will include their assessments of the cosmetic acceptability and performance/usefulness of DELP when compared to that of their previous emollient (13 parameters). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The endpoint will be measured following 14 days of use of the product. |
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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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
To obtain patients’ feedback when the product is used in the clinical setting. |
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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 | No |
E.8.1.1 | Randomised | No |
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 | 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 | No |
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 | 3 |
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 | No |
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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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |