This study evaluates the potential usefulness of photodynamic therapy with PD P 506 A in patients with distal subungual onychomycosis of the great toenail. Patients will receive four PDT treatments with PD P 506 A in weekly intervals.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
PD P 506 A is a dermal patch of 4 cm² in size loaded with 2 mg 5-ALA (as 5-ALA HCl) per cm².
Klinik für Dermatologie, Klinikum Lippe
Detmold, Germany
Klinik für Dermatologie und Allergologie KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen
Recklinghausen, Germany
Percentage of nails with Clinically Complete Cure
The Complete Clinical Clearance of each treated nail will be determined 3, 6 and 12 months after last study treatment. Based on a visual inspection, the nail(s) will either be defined as "completely cleared" or "partially" or "not cleared". To be defined as "completely cleared", a nail must show 100% absence of the 4 following clinical signs of onychomycosis (according to Scher et al., J Am Acad Dermatol. 2007 Jun;56(6):939-44): * Residual changes of the nail plate compatible with dermatophyte infection * White/yellow or orange brown/patches or streaks in or beneath the nail * Lateral onycholysis with debris in an otherwise clear nail plate * Hyperkeratoses on the lateral nail plate/nailfold edge. If the nail shows an improvement but still one of the above signs, it will be rated as "partially cleared". If the nail shows no improvement in comparison to the Screening Visit, it will be rated as "not cleared".
Time frame: 12 months after last study treatment
Percentage of nails with negative laboratory test results for onychomycosis (KOH test, periodic acid-Schiff (PAS) stain and mycology culture).
Time frame: 12 months after last study treatment
Percentage of nails with Clinically Complete Cure
The Complete Clinical Clearance of each treated nail will be determined 3, 6 and 12 months after last study treatment. Based on a visual inspection, the nail(s) will either be defined as "completely cleared" or "partially" or "not cleared". To be defined as "completely cleared", a nail must show 100% absence of the 4 following clinical signs of onychomycosis (according to Scher et al., J Am Acad Dermatol. 2007 Jun;56(6):939-44): * Residual changes of the nail plate compatible with dermatophyte infection * White/yellow or orange brown/patches or streaks in or beneath the nail * Lateral onycholysis with debris in an otherwise clear nail plate * Hyperkeratoses on the lateral nail plate/nailfold edge. If the nail shows an improvement but still one of the above signs, it will be rated as "partially cleared". If the nail shows no improvement in comparison to the Screening Visit, it will be rated as "not cleared".
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Time frame: 3 and 6 months after last study treatment
Frequency of adverse events
Time frame: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
Severity (grade1-5) of adverse events
The severity of AEs is defined as: * Grade 1 = mild * Grade 2 = moderate * Grade 3 = severe * Grade 4 = life-threatening * Grade 5 = fatal
Time frame: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
Frequency of local reactions.
Photodynamic therapy is intended to produce a phototoxic reaction, which is part of the desired effect. After PDT, treated toes may show local reactions such as redness and swelling.
Time frame: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
Severity (grade1-3) of local reactions.
The severity of local reactions is defined as: * Grade 1 = mild * Grade 2 = moderate * Grade 3 = severe
Time frame: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
One photo of each treated toenail at the beginning of each visit
Documentation of the course of the study for each treated toenail.
Time frame: At screening visit (up to 4 weeks before first treatment), during the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment.