Open label treatment of patients with chronic hand dermatitis who have participated in a clincal trial involving oral alitretinoi

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

- Male patients, or female patients if post-menopausal, or hysterectomized, or if pre-menopausal and willing to use two methods of contraception under supervision of the investigator or a gynecologist
- Aged 18 to 80 years
- Previous participation in the therapeutic trials BAP00089 or BAP00200, involving oral alitretinoin for chronic hand dermatitis
- Relapse with development of a CHaD , defined as 75% of the mTLSS of baseline of the initial study, despite ongoing treatment with topical therapy including topical steroids, or insufficient treatment response
- Written informed consent provided
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

- Patients unable to comply with the requirements of the study
- Female patients who are pregnant or who plan to become pregnant or who are breast feeding
- Female patients of childbearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously under supervision of the investigator or a gynecologist
- Patients whose disease is adequately controlled by standard non-medicated therapy (skin moisturization and protection, avoidance of irritants and allergens) and standard topical corticosteroid therapy
- Patients who have participated in study BAP00091
- Patients with known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil
- Patients with known clinically relevant allergic contact dermatitis of the hands, as demonstrated by a prior positive patch test, who have not made a reasonable effort to avoid relevant contact allergens
- patients presenting with a) psoriasis lesions (including palmo-plantar psoriasis, b) atopic dermatitis lesions requiring medicated treatment, c) acute (non-chronic) episodes of pompholyx/ dyshydrosis or of contact dermatitis d) active bacterial, fungal or viral infections of the hands
- Patients with any serious medical condition which, in the opinion of the investigator, may interfere with the safety or the evaluation of the study, including chronic heart failure, recent myocardial infarction (chest pain within the last 3 months with changes in ECG and/or increased cardiac enzymes), chronic renal failure, chronic liver failure, unstable hypothyroidism, chronic biliary disease, uncontrolled diabetes mellitus
- Patients with ALT and/or AST >2.5x ULN
- Patients with fasting triglyceridemia > 1,5x ULN
- Patients with cholesterol >1,5 x ULN and/or LDL/cholesterol > 1,5 x ULN
- Patients with hemoglobin <0,9 LLN
- Patients receiving drugs with a potential for drug-drug interaction such as systemic retinoids > 2000IU vitamin A, tetracyclines, ketoconazole, erythromycin or clarithromycin, simvastatin, or St. John’s wort within one week, or receiving systemic itraconazole within 2 weeks, before start of trial treatment
- Patients included in the study of an investigational drug other than alitretinoin within 2 months before start of trial treatment
- Patients with an active major psychiatric disorder (e.g. Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar Disorder (I or II), or schizophrenia)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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