EUCTR2008-006148-20-DE进行中（未招募）不适用
A vehicle-controlled, investigator-blinded intraindividual comparison to evaluate the safety, tolerability and efficacy of Momegalen rich cream and ointment in patients with hand and foot eczema and mild to moderate psoriasis
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
- •Female or male individuals 18 and above 18 years of age in good general health
- •Individuals with mild to moderate plaque-type psoriasis (PASI < 10) or hand and foot eczema with at least two symmetrical lesions.
- •Individuals who are willing and able to provide informed consent
- •Individuals who are willing and able to follow the requirements for study participation
- •Individuals of child-bearing potential and their partners should use a highly effective method of birth control (failure rate < 1% per year), such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
- •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
- •Pregnant or breast-feeding woman
- •Woman of child-bearing potential who plans to become pregnant or breast-feed.
- •Any therapy and/or application of systematic medication (including non-prescription products) that may interfere with the clinical evaluation such as immunosuppressives, biological systemic corticosteroids, ciclosporin, MTX, fumaric acid esters retinoid acids and/or treatment that may interfere with the skin barrier function within 30 days.
- •Individuals presenting with any other skin disease likely to interfere with the conduct of the study and/or the evaluation of the results
- •Individuals with infectious diseases (e.g. rosacea, varicella zoster, tuberculosis, syphilis), immunosupressive diseases as well as autoimmune diseases
- •Vaccination within 6 days prior to enrolment and during the study.
- •Individuals receiving topical therapy in the test area within the last 14 days prior to study entry
- •Excessive UV exposure or phototherapy (e.g. UVB, PUVA) within 14 days prior to drug application and during the conduct of the study.
- •Individuals with known hypersensitivity to any ingredients contained in the products used for treatment
- •Individuals who have participated in another clinical trial within the last 30 days prior to study entry
- •Individuals who are involved in the organisation of the trial
研究者
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