KCT0006687尚未招募未知
A multicenter, open-label, single-arm, investigator-initiated clinical trial to evaluate the efficacy and safety of alitretinoin in patients with chronic hand eczema in real patient encounter
Soon Chun Hyang University Hospital Bucheon0 个研究点目标入组 480 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 480
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 75?(Year)（—）
- 性别
- All
入选标准
- •1) Adult male and female aged 19 years or older and under 75 years old
- •2) A patient with hand eczema who meets the severe criteria of the PGA, and the symptoms of hand eczema persisted for at least 12 weeks prior to screening or recurred twice or more within 48 weeks
- •3) Those who do not respond to strong topical corticosteroid therapy for at least 4 weeks for the treatment of hand eczema
- •4) Women and men of childbearing potential who fully understand the risks of pregnancy and contraceptive warnings and are willing to maintain contraceptive compliance
- •5) A person who voluntarily decides to participate in the clinical trial after hearing sufficient explanation and consents in writing
排除标准
- •1) Those who have bacterial, fungal or viral infection on their hands, or allergic contact dermatitis
- •2) Those who need drug treatment for psoriasis or atopic dermatitis
- •3) Those with serious skin diseases other than eczema that the investigator judges may affect the efficacy and safety evaluation of this clinical trial
- •4) Those with the following diseases at the time of screening or baseline
- •? Hepatic dysfunction: aspartate transaminase (AST) or alanine transaminase (ALT) >2.5 x upper normal limit (UNL)
- •? Severe renal impairment: estimated glomerular filtration rate (eGFR)* <30 mL/min/1.73 m2
- •? Hypertriglyceridemia: triglyceride >2.0 x UNL
- •? Hypercholesterolemia: total cholesterol or low-density lipoprotein cholesterol (LDL-C) >2.0 x UNL
- •? Hemoglobin abnormality: hemoglobin ? Hypothyroidism
- •? Vitamin A overdose
- •? Pancreatitis or symptoms suspected of pancreatitis according to the examiner's judgment
- •5) Those with a history of mental illness (eg depression, etc.)
- •6) Those who have the following medical history or drug administration history
- •? Ultraviolet B (UVB) phototherapy, psoralen and ultraviolet A radiation (PUVA) treatment, systemic glucocorticoid, retinoid, and immunosuppressant administration within 4 weeks before baseline
- •? Within 2 weeks before the baseline, systemic azoles, systemic erythromycin, systemic clarithromycin, systemic tetracycline, St. John's wort administration
- •7) Those who need treatment with combination contraindications (7.3.2 contraindications) as defined in this clinical trial during the clinical trial period
- •8) Pregnant or lactating women
- •9) Persons with hypersensitivity to and/or history of clinical investigational drugs, components, and retinoids
- •10) Those who are hypersensitive to soybean oil or have a history of allergy
- •11) Those with hypersensitivity to soybeans or peanuts
- •12) A person who has been administered or applied within 4 weeks prior to screening for other clinical investigational drugs or medical devices for clinical investigation
- •13) Those who are judged inappropriate to participate in this clinical trial by the investigator for other reasons
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