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: 690

Inclusion Criteria

- 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 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.
- 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

- 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 ot a gynecologist
- Patients treated with systemic therapy e.g. corticosteroids, retinoids, immunosuppressants, within four weeks before start of trial treatment (use of inhaled steroids is permitted)
- Patients treated with phototherapy UVB, PUVA, Grenz Rays, or X-rays within four weeks before start of trial treatment
- 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 infection, chronic renal failure, chronic liver failure, thyroid disorders, chronic biliary disease, uncontrolled diabetes mellitus
- Patients known to be immunocompromised
- Patients with ALT and/or AST >2.5x ULN
- Patients with fasting triglyceridemia > 2x ULN - Patients with cholesterol >2x ULN and/or LDL/cholesterol > 2x ULN
- Patients with hemoglobin < LLN - Patients receiving drugs with a potential for drug-drug interaction such as systemic tetracyclines, ketoconazole, erythromycin or clarithromycin, cyclosporin, simvastatin, or St. John’s wort within one week, or receiving systemic itraconazole within 2 weeks, before start of trial treatment.
- 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
- Patients included in the study of any other investigational drug (except alitretinoin) within 2 months before the 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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and efficacy of a 12 to 24-week course of BAL4079 in patients with chronic hand dermatitis refractory to topical therapy previously treated with BAL4079 or placebo in study BAP00089;Secondary Objective: ;Primary end point(s): Physician’s Global Assessment (PGA) of efficacy

Secondary Outcome Measures

Name	Time	Method

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