NL-OMON41737已完成3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 116
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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;- Able to provide written informed consent;- Able to speak and read the Dutch language
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
- •- 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
研究者
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