EUCTR2010-022843-39-GB进行中（未招募）1 期
Efficacy of oral alitretinoin treatment in patients with palmo-plantar pustulosis (PPP) inadequately responding to standard topical treatment - Oral alitretinoin in PPP
GlaxoSmithKline R&D Ltd0 个研究点目标入组 33 人开始时间: 2010年11月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Male patients, or females patients if post menopausal as defined in protocol section 7.4.1., or hysterectomized, or bilaterally ovarectomized, or if pre-menopausal and willing to use at least 1 but preferrably 2 methods of contraception under supervision of the investigator or a gynecologist
- •2. Aged 18 to 75 years
- •3. Patients with PPP for at least 6 months, with or without psoriasis lesions on other areas of the skin
- •4. A PPPASI score of at least 8 with involvement of at lest 10% of the palms and/or the soles
- •5. Refractory to standard topical treatment
- •6. Written informed consent provided
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Patients unable to comply with the requirements of the study
- •2. Female patients who are pregnant or who plan to become pregnant or who are breastfeeding
- •3. Female patients of childbearing potential who cannot use or will not commit to using at least 1 but preferrably 2 effective forms of contraception simultaneously under supervision of the investigator or a gynecologist
- •4. Patients whose disease is adequately controlled by standard non-medicated therapy (skin moisturizing and protection) and standard topical corticosteriod therapy, but whose disease has relapsed following discontinuation of these treatments
- •5. Patients with known hypersensitivity to other retinoids or Vitamin A derivatives, or to any study medication component, especially soybean oil and paritally hydrogenated soybean oil
- •6. Patients treated with any of the following treatments 4 weeks before the start of the study treatment:
- •a) systemic drugs: corticosteroids, immunosuppressants, methotrexate
- •b) phototherapy: ultraviolet B light therapy (UVB), Psoralen with ultraviolet A combination therapy (PUVA), Grenz rays, X-rays
- •7. Patients treated with biologic treatment within 12 weeks prior to the start of study treatment
- •8. Patients treated with any systemic or topical retinoids within 1 year or 1 month respectively, before start of study treatment, and patients who received systemic retinoids for treatment for PPP at any time
- •9. Patients with severe generalised pustular psoriasis
- •10. Patient has a skin condition of palms and / or soles assessed as unrelated to PPP by investigator
- •11. Patients with any serious medical condition which, in the opinion of the investigator, may interfere with the safety of the patient
- •12. Patients with hepatic insufficiency, severe renal failure, uncontrolled hypercholesterolemia, uncontrolled as characterized by:
- •a. AST / ALT > 2.5 ULN
- •b. Creatinine clearance < 60ml/min (calc. Cockcroft Gault)
- •c. fasting triglyceridemia > 1.5 x ULN
- •d. fasting cholesterol >1.5 x ULN
- •e. fasting LDL cholesterol > 1.5x ULN
- •13. Patients with hypothyroidism as indicated by TSH above ULN and T4 test below LLN or hypervitaminosis A
- •14. Patients with unstable cardiac disease or poorly controlled cardiovascular risk factors, i.e.:
- •a) acute coronary syndrome or coronary revascularization (PCI, CABG) within 3 months before start of study treatment
- •b) poorly controlled diabetes mellitus (HbA1c >8.5%)
- •c) systolic blood pressure >= 160mmHg and / or diastolic blood pressure >= 100mmHg at the screening examination
- •15. Patients receiving drugs with a potential for drug-drug interactions, such as systemic tetracyclines, ketoconazole, St Johns Wort within 1 week, or receiving systemic itraconazole within 2 weeks, before the start of study treatment
- •16. Patients included in the study of an investigational drug within 2 months before start of study treatment (3 months for biologics)
- •17. Patients with a score of 20 or more on CES-D or active major psychiatric disorder (e.g. Major Depressive Disorder, Generalized Anxiety Disorder, B
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