hand eczema
Conditions
Interventions
Group I: alitretinoin 30mg/day
Group II: cyclosporine 5mg/kg/day (startdose). After 8 weeks decreased to 3-3.5
mg/kg/day.
Treatment duration is 24 weeks.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age >= 18 years and
Exclusion criteria
Exclusion criteria: - Treated with alitretinoin or cyclosporine in the previous 3 months - Patients with predominantly atopic dermatitis, in which the hands are also involved. Patients with controlled atopic dermatitis, in which the hands are mainly affected, are eligible for inclusion. - Psoriasis of the hands - Active bacterial, fungal, or viral infection of the hands - Pregnant/lactating or planning to become pregnant during the study period - Treatment with systemic medication or UV radiation within the previous 4 weeks. For systemic prednisolone; patients with treatment within the previous 2 weeks will be excluded - Mentally incompetent - Immunocompromised status - Uncontrolled arterial hypertension (minimally 3 measurements). Systolic pressure > 160 mmHg or diastolic pressure > 95 mmHg, despite starting anti-hypertensive medication (first choice amlodipine 5 mg/day) - Known or suspected allergy to ingredients in the study medications - Inclusion in a study of an investigational drug within 60 days prior to start of treatment - Current malignancy (other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and*or localized carcinoma in situ of the cervix) - Current active pancreatitis - Evidence of alcohol abuse or drug addiction - Malabsorption - Currently active gout - Recurring convulsions/epilepsy - Living vaccine (including bacillus Calmette-Guérin (BCG), varicella, measles, mumps, rubella, yellow fever, oral polio and oral typhoid) in the last 2 weeks or the planned application of such a vaccine during the study period - Chronic or recurrent infectious diseases - Contact sensitizations with clinical relevance to the hands, in which exposure to allergens is not avoided. - Hypervitaminosis A due to the use of vitamin A supplements containing >2000 IU - Use of drugs with potential to change the effective dosis of study drugs within the previous 2 weeks, Laboratory exclusion criteria post randomization: - Alanine aminotransferase (ALAT) and *or aspartate aminotransferase (ASAT) values > 200% of the upper limit of normal - Impaired renal function as indicated by a clinically relevant abnormal creatinine value (to be determined by investigator or treating physician) - Anemia as indicated by a clinically relevant lowered hemoglobin value (to be determined by investigator or treating physician), Alitretinoin specific: - Triglycerides > 200% of the upper limit of normal, - Cholesterol or low density lipoprotein (LDL) cholesterol values > 200% of the upper limit of normal - Uncontrolled hypothyroidism (to be determined by investigator or treating physician), Cyclosporine specific: - Impaired renal function as indicated by a clinically relevant abnormal creatinine value (to be determined by investigator or treating physician) - Uremia - Hyperkalemia - Hyperuricemia in patients with a medical history of gout
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for efficacy is response to treatment, defined as achieving *clear*/*almost clear* in the PGA (Physician Global Assessment) score, based on a validated Photographic Guide developed by Coenraads et al (16) at 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: improvement of >=2 steps on the PGA score, based on a validated Photographic Guide developed by Coenraads et al at 24 weeks of treatment; improvement in the Hand Eczema Severity Index (HECSI) score; improvement in the Health related Quality of Life questionnaire for hand eczema (QOLHEQ); and a Patient Global Assessement (PaGA) of improvement after 12 en 24 weeks. Adverse events will be registered, as well as time to response. Furthermore, cost-utility, quality adjusted life years (QALYs) and cost-effectiveness will be assessed with the EQ-5D-5L questionnaire while monitoring treatment related costs. | — |
Countries
Netherlands
Outcome results
None listed