EUCTR2006-006704-10-DE进行中（未招募）不适用
Efficacy and Safety of Miltefosine in Cutaneous Mastocytosis - MICUMA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •-) Chronic stable symptomatic maculopapulous cutaneous mastocytosis or systemic mastocytosis with involvement of the skin and with positive Darier’s Sign
- •-) 3 comparable lesional areas of at least 50 cm2 excluding areas in the face and intertriginous areas
- •-) Otherwise healthy according to physical examination
- •-) Aged >=18 years
- •-) Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1% per year)
- •-) Informed consent signed and dated
- •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
- •-) Clinically significant abnormalities in biochemistry or haematology
- •-) Agressive systemic mastocytosis
- •-) History or concomitant retinal pathology
- •-) Other dermatological diseases at treated skin site
- •-) Known hypersensitivity to study drugs or their components
- •-) Mental disorders
- •-) Drug or alcohol dependency
- •-) Any other chronic or acute illness requiring systemic treatment which might have any influence on the outcome of the study in the 4 weeks before start of treatment and during the study (investigator’s decision).
- •-) Immunodeficiency including HIV
- •-) Pregnancy or lactation
- •-) Participation in another clinical trial within the last 30 days
- •-) Malignant skin lesions
- •-) Target lesions covering breast implants
- •-) Radiation therapy of target areas excluding UV therapy longer than 4 weeks before start of study treatment
- •-) Dermal comorbidities within the target areas
- •-) During the past 3 days before start of treatment and during the study: topical products, Antihistamines (H1 and H2), Leukotriene antagonists
- •-) During the past 2 weeks before start of treatment and during the study: Ketotifen, Doxepin
- •-) During the past 4 weeks before start of treatment and during the study: Topical corticosteroids, UV therapy including PUVA, Systemic immunosuppressives including corticosteroids, immunomodulators, immunostimulants
- •-) During the past 12 weeks before start of treatment and during the study: Astemizole
- •-) Any concomitant medication which might influence the study objectives or are known to provoke or aggravate mastocytosis
- •-) Tranquilizers, antidepressants, sedatives, hypnotics, antiepileptics and other CNS active agents
- •-) Nonsteroidal antiinflammatory drugs
研究者
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