EUCTR2014-001493-34-DE进行中（未招募）1 期
Evaluation of the suitability of PD P 506 A in the photodynamic therapy of Distal Subungual Onychomycosis (DSO) of the great toenail.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
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, 18 - 75 years of age
- •Females up to an age of 75 years, provided that they are
- •postmenopausal, i.e. with spontaneous amenorrhea for at least 12 months or
- •not of childbearing potential because of tubal ligation or hysterectomy
- •DSO of at least one of the great toe(s) affecting 20% to 60% of the target nail without spikes will be confirmed by at least one of the three methods: the methods of KOH test, periodic acid-Schiff (PAS) stain and mycology culture
- •The toenail infection can be due to a dermatophyte, yeast or mixed infections (dermatophyte and non-dermatophyte)
- •Toenails have to be cut regularly (indicator for existing growth)
- •Signed written informed consent
- •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 11
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •Patients with the target toenail involving the matrix (lunula) or having less than 2 mm clear (unaffected) nail plate length beyond the proximal fold
- •Presence of dermatophytoma (defined as demarcated and localised thick masses (= 3 mm) of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail
- •Other conditions than DSO known to cause abnormal nail appearance
- •Topical antifungal treatment of the nails within 1 month before PDT
- •Systemic use of antifungal treatment within 3 months before PDT
- •Patients who are unwilling to provide nail clippings
- •Patients who have been previously reported to be allergic against 5-aminolevulinic acid or other ingredients of PD P 506 A
- •Diagnosis of porphyria
- •Diagnosis of polyneuropathy
- •Dementia or psychic condition that might interfere with the ability to understand the study and thus give written informed consent
- •Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment
研究者
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