NL-OMON55401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. - Alitretinoin vs cyclosporine in hand eczema
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 78
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
- •- Age >= 18 years and <= 75 years
- •- Moderate, severe or very severe hand eczema for a minimum duration of 3
- •months as defined by a validated Photoguide
- •- Refractory to standard therapy, defined as:
- •o 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
- •o Patients had also received standard skin care, including emollients and
- •barrier protection as appropriate, without significant improvement
- •o 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
- •- Treated with alitretinoin or cyclosporine in the previous 3 months
- •- 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. For systemic prednisolone; patients with treatment within the previous 2
- •weeks will be excluded
- •- 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
- •- 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
研究者
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