E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atopic dermatits |
Atopisch eczeem |
|
E.1.1.1 | Medical condition in easily understood language |
Atopic eczema |
Constitutioneel (aanleg) eczeem |
|
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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
E.1.2 | System Organ Class | 100000004858 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003640 |
E.1.2 | Term | Atopic dermatitis and related conditions |
E.1.2 | System Organ Class | 100000004858 |
|
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 |
To study if the induction of skin barrier proteins, like FLG, by coal tar leads to an improved skin barrier repair and function in the absence of a chronic inflammatory component. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Males and females in the age of 18-35 years
- Fitzpatrick skin type 1-3
- Caucasian race |
|
E.4 | Principal exclusion criteria |
- Presence of inflammatory skin disease
- Fitzpatrick skin type 4-6
- Hypersensitivity and/or intolerance to topical coal tar
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Average difference in transepidermal water loss (TEWL) and 'natural moisturizing factors' (NMF) after prophylactic and therapeutic treatment with coal tar ointment or the vehicle during two to four days after skin barrier disruption by tapestripping of the skin. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 2 (48 hours) and day 4 (96 hours) |
|
E.5.2 | Secondary end point(s) |
1. Epidermal thickness and stratum corneum thickness due to coal tar and vehicle treatment
2. Expression of skin barrier genes and proteins due to coal tar and vehicle treatment
3. Non-invasive analysis of stratum corneum hydration due to coal tar and vehicle treatment
4. Non-invasive analysis of stratum corneum cohesion due to coal tar and vehicle treatment
5. Non-invasive analysis of corneocyte morphology due to coal tar and vehicle treatment
6. Macroscopic analysis of the tapestripped skin after coal tar and vehicle treatment
7. Non-invasive analysis of cytokines in the stratum corneum after coal tar and vehicle treatment |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 2 (48 hours) and day 4 (96 hours) |
|
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 | 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 | No |
E.8.1.2 | Open | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Vehicle cream (cremor vaselini lanette FNA) |
|
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.8.5 | 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |