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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10012435 |
E.1.2 | Term | Dermatitis and eczema |
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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 |
PR1 is a modified version of the sponsor's licenced emollient, PR2. The skin emollient and hydrating properties of PR1 will hopefully last for longer than PR2. This would be a therapeutic advantage because many patients cannot re-apply their emollients as often as ideally necessary.
Part 1
The primary objective in part 1 is to compare the two emollients in terms of the effect, of a single application, on skin moisturisation levels over a 24 hour period.
Part 2
The primary objective in part 2 is to compare the two emollients in terms of their cumulative effects on skin moisturisation levels when applied twice daily over 5 consecutive days.
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to compare the cosmetic acceptability of the two products.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects fulfilling all the following criteria are eligible for inclusion in the study: Eczema sufferers. Females with essentially ‘non-hairy’ arms and legs, aged between 18 and 65 years of age. Subjects with medically dry skin to arms and lower legs and with baseline corneometer measurements differing by no more than 5 units between left and right arms and legs. Subjects willing to adopt an essentially sedentary lifestyle for the duration of study involvement (i.e. those willing to refrain from participating in any sports or significant physical activity likely to necessitate showering/bathing more often than once daily). Subjects giving their written and witnessed informed consent.
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E.4 | Principal exclusion criteria |
Subjects falling into any of the following criteria will not be eligible for the study: Subjects with any significant concurrent illness or skin disease currently involving arms or legs. Subjects with a history of skin disease or allergy relevant to the study. Subjects who have known allergies to the test products or their ingredients. Subjects using any topical or systemic medication, or drug, likely to affect the skin response to the test medicines. Subjects showing any significant visible skin abnormality or hair growth at the test measurement sites considered likely to interfere with corneometry. Subjects who have participated in an irritation test, on the same skin sites, in the past month, or a sensitisation test, on any skin site, during the past 3 months. Females who are lactating or may be pregnant or if of childbearing potential and are not taking adequate contraceptive precautions. Subjects who are concurrently participating in any other safety or efficacy test. Subjects with any irritation, tattoos, scars or birthmarks at the test sites. Subjects not willing to refrain from removing leg hair (by shaving, waxing, depilation etc.) for at least 48 hours prior to study participation and for the duration of the study. Subjects who have used oral and topical steroids for any condition within the previous 4 weeks. Employees of RSSL Pharma or Dermal Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of such employees.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint in Part 1 of the study is the difference in effect on skin moisturisation between the test products, following a single application of the emollients.
The primary endpoint in Part 2 of the study is the difference in effect on skin moisturisation between the test products, following 2 consecutive days of twice daily applications of the emollients. |
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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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | Yes |
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
| 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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Last visit, last subject. |
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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 | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |