Evaluation of the Suitability of PD P 506 A in the PDT of Distal Subungual Onychomycosis (DSO) of the Great Toenail.

NCT ID: NCT02355899

Last Updated: 2017-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-08-23

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.

Conditions

Onychomycosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD P 506 A-PDT

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).

Group Type: EXPERIMENTAL

PD P 506 A

Intervention Type: DRUG

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.

Interventions

PD P 506 A

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.

Intervention Type: DRUG

Other Intervention Names

Alacare®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

photonamic GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rolf-Markus Szeimies, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen

Locations

Klinik für Dermatologie, Klinikum Lippe

Detmold, , Germany

Klinik für Dermatologie und Allergologie KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen

Recklinghausen, , Germany

Countries

Germany

Other Identifiers

OM 01

Identifier Type: -

Identifier Source: org_study_id