hand eczema
Conditions
Interventions
Group I: alitretinoin 30mg once daily. Group II: azathioprine 1.5 or
2.5mg/kg/day in 2 doses. The treatment period is 24 weeks.
Azathioprine
Clinical trial
Hand eczema
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:;- Age * 18 years and * 75 years;- 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
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:;General criteria prior to randomization - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for efficacy is response to treatment, defined as an improvement of * 2 steps on the Physician Global Assessment (PGA), developed by Ruzicka et al, after 24 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are improvement in: mean PGA after 12 and 24 weeks, the Hand Eczema Severity Index (HECSI) score, the Health related QoL questionnaire for hand eczema (QOLHEQ), and a Patient Global Assessement (PaGA) of improvement. 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
The Netherlands
Outcome results
None listed