Alitretinoin vs Azathioprine in Severe Non-hyperkeratotic Hand Eczema
- Registration Number
- NCT03026907
- Lead Sponsor
- University Medical Center Groningen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 116
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Azathioprine Azathioprine Patients with severe chronic non-hyperkeratotic hand eczema, randomized to treatment with azathioprine. Alitretinoin Alitretinoin Patients with severe chronic non-hyperkeratotic hand eczema, randomized to treatment with alitretinoin.
- Primary Outcome Measures
Name Time Method Response to treatment/hand eczema severity (Photoguide) 24 weeks (end of treatment)
- Secondary Outcome Measures
Name Time Method Quality of Life: questionnaire. Week 12 and 24 Cost-utility. QALY's: registered direct/indirect costs, combined with EQ-5D outcome Week 12 and 24 Time to response Week 4, 8, 12, 24 Response to treatment/hand eczema severity (Photoguide) 12 weeks Response to treatment/hand eczema severity (Hand Eczema Severity Index, HECSI) Week 4, 8, 12, 24 Patient reported improvement (Patient Global Assessment, PaGA) Week 12 and 24 Cost-effectiveness: registered direct/indirect costs combined with the primary and secondary effectiveness outcomes (Photoguide/HECSI) Week 12 and 24 Safety and tolerability (adverse events) Up to 24 weeks
Trial Locations
- Locations (1)
University Medical Center Groningen
🇳🇱Groningen, Netherlands