EUCTR2005-004776-20-DE进行中（未招募）不适用
Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis
Basilea Pharmaceutica Ltd0 个研究点目标入组 250 人开始时间: 2007年2月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
- 性别
- All
入选标准
- •- Male patients, or female patients if post-menopausal, or hysterectomized, or if pre-menopausal and willing to use two methods of contraception under supervision of the investigator or a gynecologist.
- •- Aged 18 to 75 years
- •- Chronic hand dermatitis; all types of chronic hand dermatitis including hyperkeratotic, vesicular (e.g. pompholyx), and fingertip dermatitis, and fulfilling the following criteria:
- •~lasting for at least 6 months since initial diagnosis
- •~rated severe, according to the Physician Global Assessment (PGA)
- •~refractory to standard non-medicated therapy, including skin moisturization and protection, and avoidance of relevant irritants and allergens
- •~refractory to topical corticosteroid therapy, with unsatisfactory outcome (no response, transient response to ongoing therapy, or lack of tolerability) after at least 8 weeks of treatment within previous 12 months, unless contraindicated or not tolerated
- •- 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients unable to comply with the requirements of the study
- •- Female patients who are pregnant or who plan to become pregnant or who are breast feeding
- •- Female patients of childbearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously under supervision of the investigator or a gynecologist
- •- Patients whose disease is adequately controlled by standard non-medicated therapy (skin moisturization and protection, avoidance of irritants and allergens) and standard topical corticosteroid therapy
- •- Patients with known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil
- •- Patients treated with systemic therapy e.g. corticosteroids, retinoids, immunosuppressants, within four weeks before start of trial treatment (use of inhaled steroids is permitted)
- •- Patients treated with phototherapy UVB, PUVA, Grenz rays, or X-rays within four weeks before start of trial treatment
- •- Patients with known clinically relevant allergic contact dermatitis of the hands, as demonstrated by a prior positive patch test, who have not made a reasonable effort to avoid relevant contact allergens
- •- patients presenting with a) psoriasis lesions (including palmo-plantar psoriasis, b) atopic dermatitis lesions requiring medicated treatment, c) acute (non-chronic) episodes of pompholyx/ dyshydrosis or of contact dermatitis d) active bacterial, fungal or viral infections of the hands
- •- Patients presenting with any other skin disease likely to interfere with the conduct of the study and/or the evaluation of the results
- •- Patients with any serious medical condition which, in the opinion of the investigator, may interfere with the safety or the evaluation of the study, including chronic heart failure, recent myocardial infarction (chest pain within the last 3 months with changes in ECG and/or increased cardiac enzymes), chronic renal failure, chronic liver failure, unstable hypothyroidism, chronic biliary disease, uncontrolled diabetes mellitus
- •- Patients known to be immunocompromised
- •- Patients with ALT and/or AST >2.5x ULN
- •- Patients with fasting triglyceridemia > 1,5x ULN
- •- Patients with cholesterol >1,5 x ULN and/or LDL/cholesterol > 1,5 x ULN
- •- Patients with hemoglobin <0,9 LLN
- •- Patients receiving drugs with a potential for drug-drug interaction such as systemic tetracyclines, ketoconazole, erythromycin or clarithromycin, simvastatin, or St. John’s wort within one week, or receiving systemic itraconazole within 2 weeks, before start of trial treatment.
- •- Patients receiving topical retinoids, macrolides, tacrolimus, or pimecrolimus on affected areas, or taking vitamin supplements containing > 2000 IU vitamin A within one week before start of trial treatment
- •- Patients included in the study of an investigational drug within 2 months before start of trial treatment
- •- Patients with an active major psychiatric disorder (e.g. Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar Disorder (I or II), or schizophrenia)
研究者
相似试验
进行中（未招募）
不适用
Efficacy and Safety of oral Alitretinoin (Toctino®) in the Treatment of Patients with Cutaneous LupusErythematosus: A Multicentre, Open-Label, Prospective Pilot Study?dult subjects of any ethnicity and either gender with Subacute Cutaneous Lupus Erythematosus (SCLE), Discoid Lupus Erythematosus (DLE), Lupus erythematosus tumidus (LET) or Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions and without major organ involvement to investigate the efficacy of alitretinoin (30 mg per day) in the treatment of Cutaneous Lupus Erythematosus lesions.MedDRA version: 16.0Level: PTClassification code 10056509Term: Cutaneous lupus erythematosusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersEUCTR2010-024131-16-DEniversitätsklinikum Münster33
进行中（未招募）
不适用
Efficacy of alitretinoin treatment in patients with pustular form of PsoriasisPalmo-Plantar PustulosisMedDRA version: 14.1Level: LLTClassification code 10050185Term: Palmoplantar pustulosisSystem Organ Class: 100000004858EUCTR2010-022843-39-NLGlaxoSmithKline R&D Ltd30
进行中（未招募）
不适用
Efficacy of alitretinoin treatment in patients with pustular form of PsoriasisEUCTR2010-022843-39-DEGlaxoSmithKline R&D Ltd30
已完成
2 期
Efficacy of oral alitretinoin treatment in patients with palmo-plantar pustulosis (PPP) inadequately responding to standard topical treatmenthand and foot pustulosisPalmo-plantar pustulosis10014982NL-OMON36734Basilea Pharmaceutica10
进行中（未招募）
1 期
Efficacy of altiretinoin treatment in patients with pustular form of PsoriasisPalmo-Plantar PustulosisMedDRA version: 20.0 Level: LLT Classification code 10050185 Term: Palmoplantar pustulosis System Organ Class: 100000004858EUCTR2010-022843-39-GBGlaxoSmithKline R&D Ltd33