E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic atopic hand dermatitis, not responding to potent topical corticosteroids. |
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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 |
To investigate the comparative efficacy, safety and efficiency of ciclosporin microemulsion and alitretinoin in adults with severe atopic hand dermatitis.
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E.2.2 | Secondary objectives of the trial |
- Mean relative change in objective disease severity (HECSI) between baseline and week 4, 8, 12, 16, 20, 24 in both groups - Mean relative change in quality of life (Skindex 17) between baseline and week 24 in both groups - Cost-effectiveness of the studied treatment options (cost / QALY gained; assessed by means of the (EQ-5D) - Mean relative change in work productivity (assessed by means of the work limitations questionnaire (WLQ) in both groups |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male and female Patients age 18 years and ≤ 75 years - Body weight 50 to 100 kg - Chronic hand dermatitis (duration 6 months) - Atopic constitution according to - Erlanger Atopiescore and/or - positive personal history for atopic eczema, allergic rhinitis, allergic asthma and/or - elevated serum IgE (> 100 kU/L) - Severe hand dermatitis not responding to treatment with potent topical steroids for at least 4 weeks within the past 6 months due to IGA - Written informed consent
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E.4 | Principal exclusion criteria |
- Participation in other clinical trial within past 4 weeks - Pregnancy/breastfeeding - Women within reproductive age except those women who fulfil at least one of the following criteria throughout the total study and until at least 5 weeks after active study treatment in case of early study termination: - post-menopausal women (12 months physiological amenorrhoea or 6 months amenorrhoea with serum FSH level > 40 mlU/ml), - postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy) - Regular and proper use of at least two methods of contraception, including at least one method of contraception with a failure rate <1% per year (eg, implants, depot preparations, oral contraceptives, IUD). - vasectomy of the partner. - Women within reproductive age, who do not meet all of the following criteria throughout the whole study or – in case of early study termination – up to 5 weeks after active therapy: - The patient understands the teratogenic risk associated with taking the study medication. - The patient understands the need for strict monthly monitoring, the need for a reliable, continuous contraception and the need for regular pregnancy tests throughout the study and – in case of early study termination – up to 5 weeks of active therapy. - The patient is able to adequately and reliably apply methods of contraception. - The patient is informed about the possible consequences of pregnancy and knows that she must immediately contact her physician in case of suspected pregnancy. - The patient gives informed consent about knowing the potential risks and necessary measures to avoid pregnancy. - Blood and/or plasma donation during the whole study period. In case of early study termination blood and plasma donation is not allowed until 1 month after the end of active study treatment - UV-therapy within past 3 months - Concurrent photo-and / or photochemotherapy - Known Hypersensitivity / Intolerance against ciclosporin, alitretinoin or any other ingredients of Immunosporin® or Toctino® - Known Allergy against peanuts or soya - Known Hereditary fructose intolerance - Acute and/or uncontrolled chronic infectious disease - Known Congenital or acquired immune deficiency - Malignant tumor (past or present) - Uncontrolled arterial hypertension (RR systolic ≥ 160 mm Hg and/or RR diastolic≥ 90 mm Hg despite anti-hypertensive treatment) - Renal insufficiency (Serum creatinine above normal range) - Liver insufficiency (CHILD ≥ Stadium B) - Not sufficiently controlled hyperlipidemia (LDL/HDL ratio > 4 despite medical treatment) - Clinically significant thyroid hypofunction - Known Hypervitaminosis A - Concurrent supplementation of vitamin A or treatment with other retinoids - Concurrent tetracycline therapy - Concurrent therapy with St. John’s wort (“Johanniskraut“) - Known genetic diseases causing increased UV light sensitivity such as Xeroderma pigmentosum, Cockayne-syndrome, Bloom syndrome - Known Drug- and/or alcohol abuse - Known significant psychiatric morbidity
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary study endpoint: Proportion of patients with complete or almost complete clearance according to the Investigator Global Assessment (IGA) within 24-week active therapy in both groups.
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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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Yes |
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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its provided in the protocol page 33 to 36, page 38 |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |