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, or female patients if post-menopausal, or surgically sterilized, or if premenopausal willing to use two methods of contraception.
- Aged 18 to 75 years
- Chronic hand dermatitis; all types of chronic hand dermatitis including inflammatory, hyperkeratotic and vesicular (e.g. pompholyx) forms of the disease, and fulfilling the following criteria:
- rated moderate or severe, according to the Physician Global Assessment (PGA)
- non-responders in study BAP00089, or patients withdrawn for lack of efficacy after the completion of at least 12 weeks of blinded treatment in study BAP00089, or responding patients (rated clear or almost clear at the end of treatment in study BAP00089), and who relapse within 24 weeks after the end 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

- 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
- 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 treated with systemic therapy e.g. corticosteroids, retinoids, immunosuppressants, within four weeks before start of trial treatment
- Patients treated with phototherapy UVB, PUVA or X-rays within four weeks before start of trial treatment
- Patients with known clinically relevant allergic contact dermatitis of the hands, as demonstrated by a prior positive patch test, and unable to avoid exposure to the allergen or patients presenting with a) psoriasis lesions (including suspicion of palmo-plantar psoriasis, b) atopic dermatitis lesions requiring medicated treatment, c) acute flares of contact dermatitis or or pompholyx/dyshydrosis or d) active bacterial, fungal or viral infections of the hands
- Patients presenting with any other skin disease likely to interfere with the conduct of the study and/or the evaluation of the results
- 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, warfarin or St. John’s wort within one week, or receiving systemic itraconazole within 2 weeks, before start of trial treatment.
- Patients receiving topical retinoids, or taking vitamin supplements containing vitamin A within one week before start of trial treatment
- Patients with a known hypersensitivity to any component of the study medication, especially soybean oil and partly hydrogenated soybean oil.
- Patients with a history of psychiatric disorders

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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