Evaluation of the suitability of PD P 506 A in the photodynamic therapy of Distal Subungual Onychomycosis (DSO) of the great toenail.

Phase 2

• Conditions: B35.1; Tinea unguium

• Registration Number: DRKS00007618
• Lead Sponsor: photonamic GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-17
• Study Completion: 2017-08-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the clinical efficacy of PD P 506 A photodynamic therapy of distal subungual onychomycosis of the great toenail(s) on nail basis according to Scher et al. [Onychomycosis: diagnosis and definition of cure. J Am Acad Dermatol. 2007 Jun;56(6):939-44] 12 months after last photodynamic therapy.

Secondary Outcome Measures

Name	Time	Method
• Evaluation of the efficacy of PD P 506 A photodynamic therapy of distal subungual onychomycosis of the great toenail(s) on nail basis 12 months after treating participants as measured by laboratory methods.<br>• Evaluation of the clinical efficacy of PD P 506 A photodynamic therapy of distal subungual onychomycosis of the great toenail(s) on nail basis according to Scher et al. 3 and 6 months after treating participants.<br>• Evaluation of safety and tolerability of PD P 506 A photodynamic therapy of distal subungual onychomycosis of the great toenail(s).