Severe Chronic Hand Dermatitis (CHaD) Refractory to Topical Therapy
Conditions
Interventions
Product Name: Alitretinoin
Product Code: BAL4079
Pharmaceutical Form: Capsule, soft
Current Sponsor code: BAL4079
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10
Sponsors
Basilea Pharmaceutica Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark, Hungary
Outcome results
None listed