Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis. (TocyDD)

Technische Universität Dresden

Status and phase

Terminated

Phase 4

Conditions

Atopic Dermatitis

Treatments

Drug: Alitretinoin

Drug: Ciclosporin

Study type

Interventional

Funder types

Other

Identifiers

NCT01231854

TUD-TOCYDD-044

2009-017520-88 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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