NCT03026946Unknown3 期
Efficacy of Oral Alitretinoin Versus Oral Cyclosporine in Patients With Severe Recurrent Vesicular 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
- 76
- 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 cyclosporine in the treatment of patients with severe recurrent vesicular 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 recurrent vesicular 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 contact 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
- •Treated with alitretinoin or cyclosporine in the previous 3 months
- •Other morphologic types of hand eczema as defined by the Danish Contact Dermatitis Group
- •Patients with predominantly atopic dermatitis, in which the hands are also involved. (Patients with controlled atopic dermatitis, in which the hands are mainly affected, are eligible for inclusion.)
- •Psoriasis of the hands
- •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
- •Uncontrolled arterial hypertension (minimally 3 measurements). Systolic pressure > 160 mmHg or diastolic pressure > 95 mmHg, despite starting anti-hypertensive medication (first choice amlodipine 5 mg/day)
- •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
- •Evidence of alcohol abuse or drug addiction
- •Malabsorption
- •Currently active gout
- •Recurring convulsions / epilepsy
- •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
- •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)
- •Cyclosporine specific:
- •Impaired renal function as indicated by a clinically relevant abnormal creatinine value (to be determined by investigator or treating physician)
- •Hyperkalemia
- •Hyperuricemia in patients with a medical history of gout
研究组 & 干预措施
Alitretinoin
Active Comparator
Patients with severe recurrent vesicular hand eczema, randomized to treatment with alitretinoin.
干预措施: Alitretinoin (Drug)
Cyclosporin A
Active Comparator
Patients with severe recurrent vesicular hand eczema, randomized to treatment with cyclosporin A.
干预措施: cyclosporin A (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)
- 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)
- Time to response(Week 4, 8, 12, 24)
- Safety and tolerability (adverse events)(Up to 24 weeks)
- Cost-effectiveness: registered direct/indirect costs combined with the primary and secondary effectiveness outcomes (Photoguide/HECSI)(Week 12 and 24)
研究者
Marie-Louise A Schuttelaar, MD, PhD
MD, PhD
University Medical Center Groningen
研究点 (1)
Loading locations...
相似试验
招募中
4 期
AliCsa; Efficacy of oral alitretinoin versus oral cyclosporine in patients with moderate to very severe hand eczema. A randomized prospective open-label trial with blinded outcome assessmentHand eczema2024-515140-23-00Universitair Medisch Centrum Groningen78
招募中
3 期
Efficacy of oral alitretinoin versus oral cyclosporine in patients with moderate to very severe hand eczema. A randomized prospective open-label trial with blinded outcome assessment.10014982hand eczemaNL-OMON55401niversitair Medisch Centrum Groningen78
Unknown
3 期
Alitretinoin vs Azathioprine in Severe Non-hyperkeratotic Hand EczemaHand EczemaNCT03026907University Medical Center Groningen116
终止
4 期
Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis.Atopic DermatitisNCT01231854Technische Universität Dresden15
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.hand eczemaNL-OMON41737niversitair Medisch Centrum Groningen116