EUCTR2016-001204-39-PL进行中（未招募）1 期
A multi-centre, randomized, two-armed, parallel group and evaluator-blinded study of efficacy and safety of topical MOB015B in the treatment of mild to moderate distal subungual onychomycosis (DSO) - MOB015B-III
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 452
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
- •1. Males or females 18 – 75 years of age (inclusive) at the time of Informed Consent
- •2. Distal subungual onychomycosis (DSO) of at least one of the great toenail(s) affecting 20% to 60% of the target nail (evaluated by a central blinded assessor on the basis of standardized photo documentation before randomization)
- •3. Positive culture for dermatophytes
- •4. Signed written informed consent (ICF) prior to any study-related activity
- •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 406
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •1. Proximal subungual onychomycosis
- •2. Distal subungual onychomycosis of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 3 mm)
- •3. Target toenail thickness more than 3 mm
- •4. ”Spike” of onychomycosis extending to eponychium of the target toenail
- •5. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
- •6. Other conditions than DSO known to cause abnormal nail appearance
- •7. Presence of toenail infection other than dermatophytes
- •8. Previous target toenail surgery with any residual disfigurement
- •9. Topical treatment of the nails with other antifungal medication or medical device within 6 weeks before Screening/Visit 1
- •10. Systemic use of antifungal treatment within 6 months before Screening/ Visit 1
- •11. Severe moccasin tinea pedis
- •12. Signs of severe peripheral circulatory insufficiency
- •13. Uncontrolled diabetes mellitus (blood glucose not adjusted to stable levels despite antidiabetic therapy and / or careful medical monitoring by the family physician / specialist is not ensured)
- •14. Known immunodeficiency, i.e. congenital immunodeficiency, acquired immunodeficiency (e.g. HIV, some bone marrow diseases, extreme diets), iatrogenic by immunosuppressive drugs like cytostatics or by radiation therapy or immunomodulatory medications (e.g. TNF inhibitors)
- •15. Participation in another clinical trial with an investigational drug or device during the previous 3 months before Baseline/ Visit 2
- •16. Known allergy to any of the tested treatment products
- •17. A positive pregnancy test indicating pregnancy in a woman of childbearing potential* at Baseline/ Visit 2
- •18. Females who are pregnant or breastfeeding
- •19. Pre-menopausal (last menstruation = 1 year prior to screening) sexually active women who:
- •are of childbearing potential* and are not practicing an acceptable method of birth control**, or do not plan to continue practicing an acceptable method of birth control throughout the trial
- •20. Patients previously randomized in this study
- •21. History of, or current drug or alcohol abuse.
- •22. Psychiatric condition that might limit the participation in the study and/or that lead to the assumption that the patient’s ability to completely understand the consequences of consent is missing
- •23. Close affiliation with the investigator (e.g. a close relative) or persons working at a study site, or patient who is an employee of the sponsor’s company
- •24. Patients who are institutionalized because of legal or regulatory order
- •25. Any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator
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