Multicenter, randomized, open clinical trial to establish the effectiveness of of methyl-aminolevulinate 16% (Metivix®) photodynamic therapy to treat fungal infections of the nails.

• Conditions: Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]; onychomycosis

• Registration Number: EUCTR2012-003416-31-ES
• Lead Sponsor: Fundación Academia Española de Dermatología y Venereología

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-22
• Last Update Posted: 4 March 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: TO DETERMINE THE EFFECTIVENESS OF METHYL AMINOLEVULINATE (MAL) 16% PHOTODINAMIC THERAPY (PDT) (3 sessiones using 37 J/cm2) TO TREAT ONYCHOMYCOSIS;Secondary Objective: 1. To describe the safety of MAL-PDT in onychomycosis, including immediate side effects and in the following months.<br>2. To describe the improvement in quality of life of patients after treatment with MAL-PDT<br>3. To describe the influence of other factors in the effectiveness of MAL-PDT: age, gender, presence of diabetes mellitus or immunosuppression, toenail involvement, feet or hands, involvement of the first toenail, number of nails involved, the clinical type of onychomycosis, severty index and the causative organism.;Primary end point(s): Clinical improvement, measured in standardized photos the severity index of onychomycosis (OSI).;Timepoint(s) of evaluation of this end point: 3, 6 and 12 months.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Percentage of patients with complete clinical cure (OSI 0) and initial OSI reduction by 75%.<br>2. Quality of life related to onychomycosis measured by a specific questionnaire<br>3. Microbiological cure measured by the results of culture or direct examination of the fungus that causes onychomycosis and the absence of fungal structures inside the nail plate as determined by histology with PAS.;Timepoint(s) of evaluation of this end point: 3, 6, 12 months