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

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
PD P 506 A
Sponsored by
photonamic GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik für Dermatologie, Klinikum Lippe
  • Klinik für Dermatologie und Allergologie KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD P 506 A-PDT

Arm Description

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).

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Percentage of nails with negative laboratory test results for onychomycosis (KOH test, periodic acid-Schiff (PAS) stain and mycology culture).
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".
Frequency of adverse events
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
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.
Severity (grade1-3) of local reactions.
The severity of local reactions is defined as: Grade 1 = mild Grade 2 = moderate Grade 3 = severe
One photo of each treated toenail at the beginning of each visit
Documentation of the course of the study for each treated toenail.

Full Information

First Posted
January 22, 2015
Last Updated
September 18, 2017
Sponsor
photonamic GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT02355899
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 23, 2017 (Actual)
Study Completion Date
August 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
photonamic GmbH & Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PD P 506 A-PDT
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
PD P 506 A
Other Intervention Name(s)
Alacare®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of nails with Clinically Complete Cure
Description
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".
Time Frame
12 months after last study treatment
Secondary Outcome Measure Information:
Title
Percentage of nails with negative laboratory test results for onychomycosis (KOH test, periodic acid-Schiff (PAS) stain and mycology culture).
Time Frame
12 months after last study treatment
Title
Percentage of nails with Clinically Complete Cure
Description
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".
Time Frame
3 and 6 months after last study treatment
Title
Frequency of adverse events
Time Frame
During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
Title
Severity (grade1-5) of adverse events
Description
The severity of AEs is defined as: Grade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = life-threatening Grade 5 = fatal
Time Frame
During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
Title
Frequency of local reactions.
Description
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.
Time Frame
During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
Title
Severity (grade1-3) of local reactions.
Description
The severity of local reactions is defined as: Grade 1 = mild Grade 2 = moderate Grade 3 = severe
Time Frame
During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
Title
One photo of each treated toenail at the beginning of each visit
Description
Documentation of the course of the study for each treated toenail.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf-Markus Szeimies, Prof. Dr.
Organizational Affiliation
KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Dermatologie, Klinikum Lippe
City
Detmold
ZIP/Postal Code
32756
Country
Germany
Facility Name
Klinik für Dermatologie und Allergologie KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen
City
Recklinghausen
ZIP/Postal Code
45657
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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