Ciclosporin vs. Alitretinoin for severe atopic hand dermatitis. A randomized controlled investigator-initiated double-blind trial. - Tocy

• Conditions: Chronic atopic hand dermatitis, not responding to potent topical corticosteroids.

• Registration Number: EUCTR2009-017520-88-DE
• Lead Sponsor: Medical Faculty, TU Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-17
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 78

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the comparative efficacy, safety and efficiency of ciclosporin microemulsion and alitretinoin in adults with severe atopic hand dermatitis. <br>;Primary end point(s): Primary study endpoint:<br>Proportion of patients with complete or almost complete clearance according to the Investigator Global Assessment (IGA) within 24-week active therapy in both groups.<br>;Secondary Objective: -Mean relative change in objective disease severity (HECSI) between baseline and week 4, 8, 12, 16, 20, 24 in both groups<br>-Mean relative change in quality of life (Skindex 17) between baseline and week 24 in both groups<br>-Cost-effectiveness of the studied treatment options (cost / QALY gained; assessed by means of the (EQ-5D) <br>-Mean relative change in work productivity (assessed by means of the work limitations questionnaire (WLQ) in both groups