ciclosporin versus alitretinoin for severe atopic hand dermatitis.

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to investigate the comparative efficacy, safety and efficiency of ciclosporin microemulsion and alitretinoin in adults with severe atopic hand dermatitis.


Eligibility criteria:
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 atopiescore1 and/or * positive personal history for atopic eczema, allergic rhinitis, allergic asthma and/or * elevated serum ige * 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 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

Keywords: atopic hand dermatitis chronic hand dermatitis