Multicenter, randomized, open clinical trial comparing three sessions of methyl-aminolevulinate 16% (Metvix®) photodynamic therapy versus a group without photodynamic therapy to treat onychomycosis. - MAL-PDT for onychomycosis

Fundación Academia Española de Dermatología y Venereología0 个研究点开始时间: 2013年1月22日最近更新: 2013年3月4日

适应症

试验速览

暂无简介。

•Patients must meet criteria 1 and any of those in group 2:
•1. Onychomycosis of the hands or feet, as demonstrated by the positivity of any of the following: direct examination, culture (with growth of dermatophytes, yeasts or fungi non-dermatophytes) or nail plate biopsy (PAS + structures, suggestive of fungi inside the nail plate).
•2. Patients in the acceptable use of placebo:
•a) previously treated without success.
•b) with liver disease, kidney failure, or other comorbidities that increase the risk of systemic antifungal treatments.
•c) allergy or intolerance to systemic antifungal therapy.
•d) patients who express reluctance to systemic treatment and / or prolonged topical and prefer to participate in the EC.
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•1. Patients under 18 years.
•2. Inability or unwillingness of the natural or legal person / representative to give written informed consent.
•3. Pregnant or breastfeeding.
•4. Patients with diseases that may affect the nail, such as psoriasis or lichen planus.
•5. Patients diagnosed with tinea pedis simultaneously clinically apparent .
•6. Patients under current treatment with oral or topical antifungal drugs.
•7. Hypersensitivity to any component of methyl aminolevulinate (MAL).
•8. Porphyria (a contraindication to the use of MAL)
•9. Allergy to almond oil or peanut (MAL excipients involved in contact allergy)

发起方

Fundación Academia Española de Dermatología y Venereología