EFFICACY AND SAFETY OF BAL4079 IN THE TREATMENT OF SEVERE REFRACTORY CHRONIC HAND DERMATITIS.
- Conditions
- Severe Chronic Hand Dermatitis (CHaD) Refractory to Topical Therapy
- Registration Number
- EUCTR2004-000345-38-DK
- Lead Sponsor
- Basilea Pharmaceutica Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1050
Male patients, or female patients if post-menopausal, or surgically sterilized, or if premenopausal and reliably abstinent or 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: - lasting for at least 6 months since initial diagnosis - rated severe, according to the Physician Global Assessment (PGA) - refractory to topical therapy, including Class 1 topical steroids applied for at least four weeks or as indicated in label within previous 6 months unless contraindicated or not tolerated, with unsatisfactory outcome (no response, transient response, or lack of tolerability) - 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
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 a gynecologist - 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) actue 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, 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 included in the study of an investigational drug within 2 months before start of trial treatment - 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
- Secondary Outcome Measures
Name Time Method