| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| E.1.1.1 | Medical condition in easily understood language |
| Dry skin of eczema patients |
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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 | 18.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10013786 |
| E.1.2 | Term | Dry skin |
| 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 primary objective is to compare two emollients currently marketed in the UK in terms of their ability to improve and maintain skin hydration (determined by corneometry) in atopic eczema patients, when applied twice daily to their lower legs over 5 consecutive days (bilateral comparison). |
|
| E.2.2 | Secondary objectives of the trial |
| The secondary objective is to compare the patient’s opinion on the cosmetic acceptability of the two emollients tested. This is of particular interest since the patient’s preference is often crucial for their compliance with the emollient therapy. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
i) Patient considered as having atopic eczema, according to the following criteria (NICE guidelines):
Have a history of an itchy skin condition and at least three of the following:
- History of flexural involvement
- History of generally dry skin within the past 12 months
- Personal history of asthma or allergic rhinitis
- Visible dermatitis involving skin creases
- First onset of signs and symptoms as a child
ii) Female, and with an insignificant amount of hair on the lower legs so as not to impair the corneometer measurements.
iii) Between 16 and 65 years of age, and considered competent and able to understand and comply with the study requirements.
iv) Dry skin on the lower legs, defined as having mean baseline corneometer readings of less than 45 units both at screening and at the end of the washout/run-in period (prior to randomisation).
v) For the purposes of standardisation, having mean baseline corneometer measurements differing by no more than 6 units between left/right lower legs. In the event that we are unable to recruit sufficient numbers fulfilling this criterion, following agreement between the Investigator, the Statistician and the Sponsor, this may be relaxed but for as few patients as possible (ideally no more than 4) and by the minimum necessary (ideally no more than 8 unit difference), with the intention that at least 16 patients with no more than a 6 unit difference between left/right legs complete the study.
vi) Willing to adopt an essentially sedentary lifestyle for the duration of study involvement (i.e. to refrain from participating in any sports or significant physical activity likely to necessitate more frequent showering/bathing/washing of their legs than permitted by vii) below – including swimming).
vii) Willing to restrict bathing/showering or washing their legs on Tuesday (Day 2) and Thursday (Day 4) evenings only.
viii) Willing to refrain from applying any emollients to their lower legs during the washout period, or removing their lower leg hair (by shaving, waxing, depilation, etc.) for at least 48 hours prior to and during the treatment / testing phase of the study.
ix) Willing to refrain from using sun beds or sun lamps or any skin tanning products at any time throughout the study, and to avoid excessive exposure of the test sites to natural sunlight during their time in the study.
x) Willing to refrain from using non-study emollients/moisturisers or any other topical treatment anywhere on each lower leg (i.e. from the ankle to the knee) during the study.
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| E.4 | Principal exclusion criteria |
i) Any significant concurrent illness or skin disease (e.g. eczema flare) currently involving the test sites, which may interfere with the corneometry measurements.
ii) Patients with a history of intolerance or skin sensitivity to any of the ingredients.
iii) Use of any topical (on the lower legs) or systemic medication or drug which, in the Investigator’s opinion, is likely to affect skin response.
iv) Any significant visible skin abnormality or hair growth at the test measurement sites considered likely to interfere with the corneometry measurements.
v) Any irritation, tattoos, scars or birthmarks at the skin measurement sites that can potentially interfere with the study corneometry measurements.
vi) Patients with systemic diseases which, in the opinion of the investigator, may adversely influence their participation in the trial.
vii) 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.
viii) Participation in an irritation test, on the lower legs, in the past month, or a positive reaction in a sensitisation test, on any skin site, during the past 3 months.
ix) Patients currently taking, or having taken within the 4 weeks prior to the screening (Day -7), any oral or topical (on the lower legs) antibiotics, corticosteroids or immunosuppressants for acute conditions. Patients that are taking low dose oral corticosteroids for long term, chronic conditions (such as arthritis, inflammatory bowel conditions) or using inhaled corticosteroids (for asthma or COPD) long term will be eligible if, in the opinion of the Investigator, their medication will not have any impact on the results of the trial.
x) Patients who are pregnant or lactating (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). Negative pregnancy testing will not be necessary.
xi) Patients of child bearing potential who are not taking adequate contraceptive precautions.
xii) Patients considered unable or unlikely to attend the necessary follow-up visits.
xiii) Patients with another member of the household already enrolled in the study (this is to avoid possible mix up between assigned treatments).
xiv) Employees of RCR or Dermal Laboratories, or an immediate family member (partner, offspring, parents, siblings or sibling’s offspring) of such employees. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary efficacy analysis variable will be the area under the curve (AUC) of the change from baseline (i.e. before treatment) on the skin corneometry measurements collected for each leg over a 5 day period. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Corneometry measurements will be taken from the same sites on both legs, three times each day: before treatment at 09.00* and after treatment at 13.00* and 17.00*hrs (*nominal timings); over 5 consecutive days. |
|
| E.5.2 | Secondary end point(s) |
The secondary endpoints will be as follows:
i) Three patient-reported outcomes comparing: a) overall acceptability; b) whether they would use the product again; and c) which product they preferred. This will be recorded using a cosmetic acceptability questionnaire given to the patients after they complete the 5 day treatment period.
ii) Comparison of the first corneometry measurement on each of days 2, 3, 4 and 5 versus baseline for the test IMP, as well as the comparator, separately.
iii) Comparison between the test IMP and the comparator of the first corneometry measurements obtained on each of days 1 (baseline) to 5.
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
The Cosmetic Acceptability Questionnaire will be given to the patients to complete in the morning of Day 5 (end of treatment), after their final application of the study treatments.
Corneometry measurements will be the same as recorded for the primary endpoint. |
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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 | 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 |
| Bilateral (within-subject) comparison |
|
| 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 |
| Zerobase Emollient Cream (CE Marked Class I Medical Device) |
|
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.5.1 | Number of sites anticipated in the EEA | 1 |
| 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 | 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 |
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