EUCTR2015-001447-37-NL进行中（未招募）不适用
Efficacy of oral alitretinoin versus oral azathioprine in patients with severe chronic non-hyperkeratotic hand eczema. A randomized prospective open-label trial with blinded outcome assessment. - ALIAZ-trial
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •- Not previously treated with alitretinoin or azathioprine
- •- Able to provide written informed consent
- •- Able to speak and read the Dutch language
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •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
- •- Use of topical corticosteroids > class II within 1 week before enrolment
- •- Mentally incompetent
- •- Currently active depression
- •- 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 avoidance of exposure is unclear
- •- 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
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