Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis.

NCT ID: NCT01231854

Last Updated: 2014-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-03-31

Brief 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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ciclosporingroup

Group Type: ACTIVE_COMPARATOR

Ciclosporin

Intervention Type: DRUG

In accordance with the current guideline concerning the use of ciclosporin in dermatology and the current guideline management of hand eczema the daily oral dosage of ciclosporin microemulsion is 2.7 to 4.0 mg/kg bodyweight (half of the total daily dosage will be administered in the morning and in the evening). To enable both body-weight adjusted treatment and double-blind treatment patients will be allocated to 2 different dosages depending on their body weight (50-74.9 kg: daily dosage 200 mg; 75-100 kg: daily dosage 300 mg).

Alitretinoingroup

Group Type: ACTIVE_COMPARATOR

Alitretinoin

Intervention Type: DRUG

In accordance with the current guideline management of hand eczema alitretinoin will be administered orally in a constant daily dosage of 30 mg.

Interventions

Ciclosporin

In accordance with the current guideline concerning the use of ciclosporin in dermatology and the current guideline management of hand eczema the daily oral dosage of ciclosporin microemulsion is 2.7 to 4.0 mg/kg bodyweight (half of the total daily dosage will be administered in the morning and in the evening). To enable both body-weight adjusted treatment and double-blind treatment patients will be allocated to 2 different dosages depending on their body weight (50-74.9 kg: daily dosage 200 mg; 75-100 kg: daily dosage 300 mg).

Intervention Type: DRUG

Alitretinoin

In accordance with the current guideline management of hand eczema alitretinoin will be administered orally in a constant daily dosage of 30 mg.

Intervention Type: DRUG

Other Intervention Names

Immunosporin; Toctino

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Saxony, Germany

Countries

Germany

Other Identifiers

2009-017520-88

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TUD-TOCYDD-044

Identifier Type: -

Identifier Source: org_study_id