NCT03026907Unknown3 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Response to treatment/hand eczema severity (Photoguide)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Alitretinoin
Active Comparator
Patients with severe chronic non-hyperkeratotic hand eczema, randomized to treatment with alitretinoin.
干预措施: Alitretinoin (Drug)
Azathioprine
Active Comparator
Patients with severe chronic non-hyperkeratotic hand eczema, randomized to treatment with azathioprine.
干预措施: Azathioprine (Drug)
结局指标
主要结局
Response to treatment/hand eczema severity (Photoguide)
时间窗: 24 weeks (end of treatment)
次要结局
- Cost-utility. QALY's: registered direct/indirect costs, combined with EQ-5D outcome(Week 12 and 24)
- Quality of Life: questionnaire.(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)
研究者
Marie-Louise A Schuttelaar, MD, PhD
Principal investigator, dermatologist, MD, PhD
University Medical Center Groningen
研究点 (1)
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