Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD P 506 A-PDT | Experimental | One PD P 506 A-patch will be administered to each great toenail for 4 hours. After removal of the study medication the study nail(s) s will be illuminated with red light of defined wavelength (PDT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD P 506 A | Drug | PD P 506 A is a dermal patch of 4 cmĀ² in size loaded with 2 mg 5-ALA (as 5-ALA HCl) per cmĀ². |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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):
If the nail shows no improvement in comparison to the Screening Visit, it will be rated as "not cleared". | 12 months after last study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of nails with negative laboratory test results for onychomycosis (KOH test, periodic acid-Schiff (PAS) stain and mycology culture). | 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):
If the nail shows no improvement in comparison to the Screening Visit, it will be rated as "not cleared". |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rolf-Markus Szeimies, Prof. Dr. | KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik fĆ¼r Dermatologie, Klinikum Lippe | Detmold | 32756 | Germany | |||
| Klinik fĆ¼r Dermatologie und Allergologie KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 and 6 months after last study treatment |
| Frequency of adverse events | 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:
| 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. | 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:
| 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. | 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. |
| Recklinghausen |
| 45657 |
| Germany |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |