Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis.

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Treatments: Alitretinoin; Cyclosporine; Cyclosporins; Tretinoin

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