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

    Summary
    EudraCT number
    		 2014-001493-34
    Trial protocol
    		 DE  
    Global end of trial date
    23 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Apr 2020
    First version publication date
    23 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OM01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    photonamic GmbH & Co. KG
    Sponsor organisation address
    Eggerstedter Weg 12, Pinneberg, Germany,
    Public contact
    Clinical Project Management, photonamic GmbH & Co. KG, info@photonamic.de
    Scientific contact
    Clinical Project Management, photonamic GmbH & Co. KG, info@photonamic.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluation of the clinical efficacy of PD P 506 A photodynamic therapy of DSO of the great toenail(s) on nail basis 12 months after treating participants.
    Protection of trial subjects
    None specified.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jan 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    12
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 At Screening Visit, small nail clippings of the diseased toenails were taken for the confirmation of clinical DSO diagnosis using the methods of tests on native preparation, mycological culture, and histopathological examination with periodic acid Schiff (PAS) staining.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PD P 506 A PDT
    Arm description
    		 PD P 506 A is a square, skin coloured, self-adhesive patch with rounded corners. One patch contains 2 mg 5-aminolevulinic acid (present as 5-aminolevulinic acid hydrochloride) per cm² and has a sizeof 4 cm². As there is evidence from literature that PDT for onychomycosis needs repeating in order to show maximum efficacy, PDT in this study was performed four times in intervals of one week. One patch of PD P 506 A was administered to the patient’s diseased great toenail(s) for 4 hours at Visits 1-4. After removal of the study medication and degreasing, the study nail(s) were illuminated (PDT) with a predefined light dose (37 J/cm²) at 630 ± 5 nm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PD P 506 A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Topical use
    Dosage and administration details
    One patch of PD P 506 A were administered to the patient’s diseased great toenail(s) for four hours at Visits 1 - 4

    Number of subjects in period 1
    		PD P 506 A PDT
    Started
    22
    Completed
    14
    Not completed
    8
         Treatment failure or recurrence of DSO
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 22 22
    Age categorical
    Units: Subjects
        40 - <65 years
    		 12 12
        65 - 75 years
    		 10 10
    Age continuous
    Age (years)
    Units: years
        arithmetic mean (standard deviation)
    		 63 ± 8.1 -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 18 18
    Number of study nails
    Units: Subjects
        Patients with 1 study nail
    		 12 12
        Patients with 2 study nails
    		 10 10
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients who received at least one application of the study medication and who showed one valid efficacy assessment after last PDT

    Subject analysis set title
    SFS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one application of the study medication showing at least one safety assessment.

    Subject analysis set title
    PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients who received four applications of study treatment, who showed no major protocol violation, and who provided valid efficacy data at Visit 7 (12 months after last PDT).

    Subject analysis sets values
    		 FAS SFS PPS
    Number of subjects
    22
    22
    21
    Age categorical
    Units: Subjects
        40 - <65 years
    12
    12
    11
        65 - 75 years
    10
    10
    10
    Age continuous
    Age (years)
    Units: years
        arithmetic mean (standard deviation)
    63 ± 8.1
    63 ± 8.1
    63 ± 8.3
    Gender categorical
    Units: Subjects
        Female
    4
    4
    4
        Male
    18
    18
    17
    Number of study nails
    Units: Subjects
        Patients with 1 study nail
    12
    12
    11
        Patients with 2 study nails
    10
    10
    10

    End points

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    End points reporting groups
    Reporting group title
    PD P 506 A PDT
    Reporting group description
    		 PD P 506 A is a square, skin coloured, self-adhesive patch with rounded corners. One patch contains 2 mg 5-aminolevulinic acid (present as 5-aminolevulinic acid hydrochloride) per cm² and has a sizeof 4 cm². As there is evidence from literature that PDT for onychomycosis needs repeating in order to show maximum efficacy, PDT in this study was performed four times in intervals of one week. One patch of PD P 506 A was administered to the patient’s diseased great toenail(s) for 4 hours at Visits 1-4. After removal of the study medication and degreasing, the study nail(s) were illuminated (PDT) with a predefined light dose (37 J/cm²) at 630 ± 5 nm.

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients who received at least one application of the study medication and who showed one valid efficacy assessment after last PDT

    Subject analysis set title
    SFS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All patients who received at least one application of the study medication showing at least one safety assessment.

    Subject analysis set title
    PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All patients who received four applications of study treatment, who showed no major protocol violation, and who provided valid efficacy data at Visit 7 (12 months after last PDT).

    Primary: Evaluation of the clinical efficacy of PD P 506 A photodynamic therapy of DSO of the great toenail(s) on nail basis 12 months after treating participants.

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    End point title
    		 Evaluation of the clinical efficacy of PD P 506 A photodynamic therapy of DSO of the great toenail(s) on nail basis 12 months after treating participants. [1]
    End point description
    End point type
    Primary
    End point timeframe
    12 months after last study treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The statistical analysis of study data was done in a descriptive way only. No statistical tests were performed.
    End point values
    		 FAS PPS
    Number of subjects analysed
    22
    21
    Units: % of nails with Clinically Complete Cure
        Toenails with Clinically Complete Cure
    0
    0
        Tolal toenails treated
    32
    31
    No statistical analyses for this end point

    Secondary: Evaluation of the efficacy of PD P 506 A photodynamic therapy of DSO of the great toenail(s) on nail basis 12 months after treating participants as measured by laboratory methods.

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    End point title
    		 Evaluation of the efficacy of PD P 506 A photodynamic therapy of DSO of the great toenail(s) on nail basis 12 months after treating participants as measured by laboratory methods.
    End point description
    Percentage of nails with negative result after 12 months using laboratory methods (KOH test, periodic acid-Schiff (PAS) stain and mycology culture).
    End point type
    Secondary
    End point timeframe
    12 months after the last study treatment
    End point values
    		 FAS PPS
    Number of subjects analysed
    22
    21
    Units: % of nails with negative labor results
        Number of treated toenails
    32
    31
        Number of toenails with negative KOH test
    12
    12
        Number of toenails with negative PAS test
    7
    7
        Number of toenails with negative mycological cultu
    17
    17
    No statistical analyses for this end point

    Secondary: Evaluation of the efficacy of PD P 506 A photodynamic therapy of DSO of the great toenail(s) on nail basis 3 and 6 months after treating participants.

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    End point title
    		 Evaluation of the efficacy of PD P 506 A photodynamic therapy of DSO of the great toenail(s) on nail basis 3 and 6 months after treating participants.
    End point description
    End point type
    Secondary
    End point timeframe
    3 and 6 months after treating participants
    End point values
    		 FAS PPS
    Number of subjects analysed
    22
    21
    Units: % of nails with CCR after 3 and 6 months
        All treated toenails
    32
    31
        Number of toenails with CCR after 3 months
    0
    0
        Number of toenails with CCR after 6 months
    0
    0
    No statistical analyses for this end point

    Secondary: Evaluation of safety and tolerability of PD P 506 A photodynamic therapy of DSO of the great toenail(s).

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    End point title
    		 Evaluation of safety and tolerability of PD P 506 A photodynamic therapy of DSO of the great toenail(s).
    End point description
    End point type
    Secondary
    End point timeframe
    During 3m after first PDT
    End point values
    		 SFS
    Number of subjects analysed
    22
    Units: Freq'cy of AE /local tolerability signs
        Number of Adverse Events
    0
        Number of local reactions during patch application
    2
        Number of local reactions during illumination
    11
        N of local reactions after occl. dressing removal
    9
        Number of local reactions
    22
        Pts with LR during patch application
    1
        Pts with LR during illumination
    6
        Pts wth LR after occl dressing removal
    6
        Pts with any local reaction
    9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Between patient inclusion and Visit 5.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Adverse Events
    Reporting group description
    		 All patients who received at least one application of the study medication showing at least one safety assessment.

    Reporting group title
    Local reactions
    Reporting group description
    		 Local reactions to application of study medication and study procedure (PDT at Visit 1, 2, 3, 4) are known adverse reactions to PD P 506 A-PDT and therefore always regarded as being related to the procedure.

    Serious adverse events
    		 Adverse Events Local reactions
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adverse Events Local reactions
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    9 / 22 (40.91%)
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    0 / 22 (0.00%)
    5 / 22 (22.73%)
         occurrences all number
    0
    11
    Application site pruritus
         subjects affected / exposed
    0 / 22 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    0
    6
    Application site erosion
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Application site erythema
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    Application site irritation
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Application site paraesthesia
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Nov 2014
    Reason: Request by IEC Westfalen-Lippe (1) Request by competent authority BfArM (2, 3, 4, 5) Amendments: 1. Addition of exclusion criterion “Diagnosis of polyneuropathy” 2. Re-check of inclusion/exclusion criteria on visits 2, 3 and 4 3. Patient to be asked for AEs and changes in concomitant medication at Visit 1 (day of first PDT) 4. Documentation of actions taken in case of local reactions in CRF 5. Documentation of AEs in CRF between patient inclusion and Visit 4 (instead of “between study treatment and Visit 4”)
    21 Apr 2015
    Reason: Adaptation of inclusion / exclusion criteria due to low recruitment Amendments: 1. Raising of upper maximum age to 75 (instead of 64) 2. Inclusion of female patients. Females need to be postmenopausal or not of childbearing potential because of tubal ligation or hysterectomy.
    11 Dec 2015
    Reason: Administrative reasons (1, 3) Change of study sites (2) Amendments: Change of responsibility for PV from medac GmbH to spm² – safety projects & more GmbH including revision of the affected chapters of CSP 2. Site Fürth was replaced by site Detmold (site Fürth had not recruited any patient) 3. Appendices 2 (SPC Alacare) and 3 (SAE form) were replaced by current versions

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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