Alitretinoin vs Azathioprine in Severe Non-hyperkeratotic Hand Eczema

Exclusion Criteria

• •General criteria prior to randomization
• •Treatment with alitretinoin or azathioprine in the previous 3 months
• •Hyperkeratotic palmar eczema as defined by the Danish Contact Dermatitis Group
• •Patients with predominantly atopic dermatitis, in which the hands are also involved. Patients with mild atopic dermatitis, in which the hands are mainly affected are eligible for inclusion.
• •Psoriasis
• •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
• •Mentally incompetent
• •Immunocompromised status
• •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
• •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
• •Evidence of alcohol abuse or drug addiction
• •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
• •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)
• •Azathioprine specific
• •Patients with low or absent thiopurine methyltransferase (TPMT) activity (defined in our center as \<52 nmol/gHb/hour, combined with genotyping showing homozygous of compound heterozygous mutations) and a subsequent risk for life-threatening myelotoxicity