Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis.

Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis. A Randomized Controlled Investigator-initiated Double-blind Trial.

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.

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