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-GB
- 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 hysterectomized, or if premenopausal and willing to use two methods of contraception under supervision of the investigator or a gynecologist.
- Aged 18 to 75 years
- Chronic hand dermatitis; all types of chronic hand dermatitis including hyperkeratotic, vesicular (e.g. pompholyx), and fingertip dermatitis 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 standard non-medicated topical therapy, including skin moisturization and protection, and avoidance of relevant irritants and allergens
- refractory to topical corticosteroid therapy, with unsatisfactory outcome (no response, transient response to on-going therapy, or lack of tolerability) after at least 8 weeks of treatment within the previous 6 months, including Class 1 topical steroids (most potent; for example, 0.05% clobetasol dipropionate ointment) applied for at least 4 weeks or as indicated in label, unless contradicted or not tolerated
- 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
;
- Male patients, or female patients if post-menopausal, or hysterectomized, or if premenopausal and willing to use two methods of contraception under supervision of the investigator or a gynecologist.
- Aged 18 to 75 years
- Chronic hand dermatitis; all types of chronic hand dermatitis including hyperkeratotic, vesicular (e.g. pompholyx), and fingertip dermatitis 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 standard non-medicated topical therapy, including skin moisturization and protection, and avoidance of relevant irritants and allergens
- refractory to topical corticosteroid therapy, with unsatisfactory outcome (no response, transient response to on-going therapy, or lack of tolerability) after at least 8 weeks of treatment within the previous 6 months, including Class 1 topical steroids (most potent; for example, 0.05% clobetasol dipropionate ointment) applied for at least 4 weeks or as indicated in label, unless contradicted or not tolerated
- 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 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, but whose disease has relapsed following discontinuation of these treatments
- 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 (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 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 (non-chronic) episodes of contact dermatitis or of pompholyx/dyshydrosis 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 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 an investigational drug within 2 months before start of trial treatment
- Patients with a score 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 (I or II), or schizophrenia)
;
- 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, but whose disease has relapsed following discontinuation of these treatments
- 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 (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 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 (non-chronic) episodes of contact dermatitis or of pompholyx/dyshydrosis 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 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 an investigational drug within 2 months before start of trial treatment
- Patients with a score 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 (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