Follow up Efficacy and safety Study of BAL4079 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Therapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

- Written informed consent provided
- Male patients, and female patients either without childbearing potential or of childbearing potential and using appropriate contraception, who participated in study BAP00089 and were either:
a) Responders (rated clear or almost clear according to the PGA at the end of treatment), and relapsing within 24 weeks after the end of treatment (TLSS score = 75% that of baseline in BAP00089), or
b) Non-responders, rated mild or moderate according to the PGA after 24 weeks of treatment

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

- Female patients who are pregnant or who plan to become pregnant or who are breast feeding
- Female patients of child-bearing 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 treated with systemic therapy e.g. corticosteroids, retinoids, immunosuppressants, within four weeks before start of trial treatment (1) (use of inhald steroids is permitted)
- Patients treated with phototherapy UVB, PUVA, Grenz rays, or X-rays within four weeks before start of trial treatment (1)
- 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 hard failure, recent myocardial infraction (chest pain within the last three month with changes in ECG and/or increased cardiac enzymes), chronic infection, 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 triglyceridermia > 2x ULN
- Patients with cholesterol > 2X ULN and /or LDL/cholesterol > 2x ULN
- Patients with hemoglobin - Patients receiving drugs with potential for drug-drug interaction such as systemic tetracyclines, ketoconazole, erythromycin or claritromycin, cyclosporine, simvastatin, or St. John’s wart within one week or receiving systemic intraconozole within 2 weeks, before start of trial treatment.(1)
- Patients receiving topical retinoids, macrolides, tacrolimus,or pimecrolimus on affected areas or taking vitamin supplements containing > 2000 IU vitamin A within one week before start of trial treatment (1)
- Patients included in the study of any other investigational drug (except alitretinoin) within 2 months before start of trial treatment
- Patients with a sccore of 20 or more on the CES-D depression scale at screening, or with a history of major psychiatric disorder (e.g. Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar Disorder (I or II), or schizophrenia)

(1) Patients may be enrolled after a corresponding wash-out period (see section 4.4)

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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