E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Eczema sufferers with dry skin. |
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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 study is to compare, using objective instrumental efficacy endpoints, and under controlled laboratory conditions simulating normal clinical use, the effects on skin condition of repeated daily bathing in water with, and without, the addition of an emollient bath additive. |
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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 |
Approximately 12 male or female subjects between 18 and 65 years of age will be included in the study. Subjects will be required to have a history of eczema and present with dry skin on the arms and hands. Subjects will be asked to refrain from using moisturisers and moisturising soaps on arms and hands in the week prior to the study and for the duration of the study.
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E.4 | Principal exclusion criteria |
The following will be excluded from participating in the study: 1. Subjects with any significant concurrent illness or skin disease at the test sites. 2. Subjects with a history of other skin disease or allergy relevant to the study. 3. Subjects who have known allergies to the test product or its ingredients 4. Subjects using any topical or systemic medication or drug likely to affect the skin or its response to treatment 5. Subjetcs with eczema visually differing in severity between left/right test sites 6. Subjects with any significant visible skin abnormality at the test site 7. Subjects that have participated in an irritation test, on the same skin site, in the past month, or a sensitisation test, on any skin site, during the past 3 months 8. Females who are lactating, or are pregnant, or are likely to become pregnant during their time in the study. (There are no safety concerns at all regarding these groups using the bath additive – their exclusion is simply because it is generally considered inappropriate for them to take part in clinical trials. 9. Subjects that are currently participating in any other safety test. 10. Subjects with any irritation, tattoos, scars or birthmarks at the test sites 11. Subjects that have used any unlicensed medicine within the previous 30 days 12. Employees of RSSL Pharma or Dermal Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of an employee.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints will be: skin hydration measured by corneometry; skin pH; and water loss from the skin, measured by Trans-epidermal Water Loss instrument (TEWL). |
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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 | No |
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 | No |
E.8.1.3 | Single blind | Yes |
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 |
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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
| 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 | 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 trial is defined as when the last patient has completed their last visit at the test centre. |
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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 | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |