alitretinoin vs azathioprine in severe non-hyperkeratotic hand eczema

Conditions: Hand Eczema

Summary: the purpose of this study is to compare the efficacy of alitretinoin and azathioprine in the treatment of patients with severe chronic non-hyperkeratotic hand eczema.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and ≤ 75 years * severe or very severe chronic non-hyperkeratotic hand eczema for a minimum duration of 3 months as defined by a physician global assessment (pga) using a validated photoguide * refractory to standard therapy, defined as: patients received treatment with topical corticosteroids of class ii or higher for at least 8 weeks within 3 months before enrolment, with either no response or a transient response. patients had also received standard skin care, including emollients and barrier protection as appropriate, without significant improvement. patients had avoided irritants and allergens, if identified, without significant improvement. * women of childbearing potential are required to use at least two forms of contraception for at least 1 month before starting treatment, during treatment, and for at least 1 month after finishing treatment; these women are required to take monthly pregnancy tests * able to provide written informed consent * able to speak and read the dutch language 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 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) 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

Keywords: alitretinoin azathioprine hand eczema