Clinical trial NCT02355899: Evaluation of the Suitability of PD P 506 A in the PDT of Distal Subungual Onychomycosis (DSO) of the Great Toenail.
Official title: Evaluation of the Suitability of PD P 506 A in the Photodynamic Therapy of Distal Subungual Onychomycosis (DSO) of the Great Toenail.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Onychomycosis
Lead sponsor: photonamic GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2015-02-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male 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, confirmed before Visit 1 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of nails with Clinically Complete Cure
timeFrame: 12 months after last study treatment
Secondary outcomes:
measure: Percentage of nails with negative laboratory test results for onychomycosis (KOH test, periodic acid-Schiff (PAS) stain and mycology culture).
timeFrame: 12 months after last study treatment
measure: Percentage of nails with Clinically Complete Cure
timeFrame: 3 and 6 months after last study treatment
measure: Frequency of adverse events
timeFrame: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
measure: Severity (grade1-5) of adverse events
timeFrame: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
measure: Frequency of local reactions.
timeFrame: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
measure: Severity (grade1-3) of local reactions.
timeFrame: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
measure: One photo of each treated toenail at the beginning of each visit
timeFrame: 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.
Other outcomes:
Locations:
city: Detmold
country: Germany
facility: Klinik für Dermatologie, Klinikum Lippe
city: Recklinghausen
country: Germany
facility: Klinik für Dermatologie und Allergologie KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen
Study officials:
affiliation: KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen
name: Rolf-Markus Szeimies, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: