E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Dry or chapped skin conditions which may also be pruritic (itchy) or inflamed e.g. eczema, psoriasis, elderly pruritus and 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 objective of the trial is to confirm the product's effectiveness and cosmetic acceptability when used by patients with medically dry skin in the normal clinical situation.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives will be to assess the patients’ opinion of the new shower container, and their understanding of the Patient Information Leaflet, in particular, with respect to the instructions for use and safety information. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female patients, upwards of 13 years of age and who normally shower, presenting to their GP with a dry and pruritic skin condition such as eczema, psoriasis, elderly pruritus or dermatitis, and currently receiving prescribed emollient treatment, either alone or as an adjunct to other topical pharmaco-therapy, will be eligible for inclusion. |
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E.4 | Principal exclusion criteria |
i) Patients less than 13 years old. ii) Patients older than 13 years but ‘incompetent’ to perform the evaluations. iii) Patients who do not normally shower. iv) Patients with acute, weeping or infected dermatoses. v) Patients with 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) Patients who have received any unlicensed drug within the last 30 days or who are scheduled to receive an investigative drug other than the study medication during the period of the study. vii) Patients with systemic diseases which, in the opinion of the investigator, may adversely influence their participation in the trial. viii) Female patients who are pregnant, lactating or trying to become pregnant (although there are no particular safety concerns in these patient groups, it is generally inappropriate for them to participate in clinical trials without overriding justification). ix) Patients considered unable or unlikely to attend the necessary follow-up consultation. x) Patients who themselves, or whose parent/guardian, are considered unlikely to understand the patient information leaflet which is to be written only in English.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints will be the patients’
i. assessment of the performance of the shower gel in terms of four characteristics : skin smoothness, softness, lack of dryness and lack of itchiness.
ii. assessment of the cosmetic acceptability of the shower gel in terms of four attributes: texture/feel, lack of fragrance, cleaning action and lack of greasiness.
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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 | Yes |
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 | 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 |
Cosmetic acceptability of the special shower container |
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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 | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 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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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 | |