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

Onychomycosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355899
• Other study ID #: OM 01
• Status: Completed
• Phase: Phase 2
• First received: January 22, 2015
• Last updated: September 18, 2017
• Start date: January 2015
• Est. completion date: August 23, 2017

Study information

• Verified date: September 2017
• Source: photonamic GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 23, 2017
• Est. primary completion date: August 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Germany	Klinik für Dermatologie, Klinikum Lippe	Detmold
Germany	Klinik für Dermatologie und Allergologie KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen	Recklinghausen

Sponsors (1)

Lead Sponsor	Collaborator
photonamic GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	12 months after last study treatment
Secondary	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
Secondary	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".	3 and 6 months after last study treatment
Secondary	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
Secondary	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	During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
Secondary	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
Secondary	Severity (grade1-3) of local reactions.	The severity of local reactions is defined as: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe	During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
Secondary	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.