- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02355899
Evaluation of the Suitability of PD P 506 A in the PDT of Distal Subungual Onychomycosis (DSO) of the Great Toenail.
Evaluation of the Suitability of PD P 506 A in the Photodynamic Therapy of Distal Subungual Onychomycosis (DSO) of the Great Toenail.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Detmold, Germany, 32756
- Klinik für Dermatologie, Klinikum Lippe
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Recklinghausen, Germany, 45657
- Klinik für Dermatologie und Allergologie KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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).
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of nails with Clinically Complete Cure
Time Frame: 12 months after last study treatment
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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):
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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12 months after last study treatment
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Percentage of nails with Clinically Complete Cure
Time Frame: 3 and 6 months after last study treatment
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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):
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
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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
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During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
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Severity (grade1-5) 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
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The severity of AEs is defined as:
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During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
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Frequency of local reactions.
Time Frame: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
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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.
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During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
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Severity (grade1-3) of local reactions.
Time Frame: During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
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The severity of local reactions is defined as:
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During the treatment phase on day 0, 7, 14 and 21, and 3, 6 and 12 months after last study treatment
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One photo of each treated toenail at the beginning of each visit
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.
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Documentation of the course of the study for each treated toenail.
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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.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rolf-Markus Szeimies, Prof. Dr., KLINIKUM VEST GMBH Knappschaftskrankenhaus Recklinghausen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OM 01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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