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    Summary
    EudraCT Number:2014-001493-34
    Sponsor's Protocol Code Number:OM01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-14
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2014-001493-34
    A.3Full title of the trial
    Evaluation of the suitability of PD P 506 A in the photodynamic therapy of Distal Subungual Onychomycosis (DSO) of the great toenail.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Test of 5-ALA-containing patch application and subsequent illumination as therapy of mild to moderate fungal infections of the great toenail.
    A.4.1Sponsor's protocol code numberOM01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of Sponsorphotonamic GmbH & Co. KG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportphotonamic GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationphotonamic GmbH & Co. KG
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressTheaterstrasse 6
    B.5.3.2Town/ cityWedel
    B.5.3.3Post code22880
    B.5.3.4CountryGermany
    B.5.6E-mailinfo@photonamic.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Alacare 8 mg medicated plaster
    D.2.1.1.2Name of the Marketing Authorisation holderGalderma Spirig
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Medicated plaster
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpilesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN5-aminolevulinic acid hydrochloride
    D.3.9.1CAS number 5451-09-2
    D.3.9.3Other descriptive nameAMINOLEVULINIC ACID HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB21578
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Onychomycosis (OM) is a chronic fungal infection of the finger- or toenails and one of the commonest dermatological conditions. It accounts for one third of fungal skin infections and constitutes about a half of all nail abnormalities.
    In most cases, OM is caused by dermatophytes, mostly Trichophyton rubrum (84-90%). Yeasts (e.g. Candida parapsilosis; approx. 8 %) or moulds like Scopulariopsis brevicaulis (approx. 6%) are other common causative organisms of OM.
    E.1.1.1Medical condition in easily understood language
    Onychomycosis is a chronic fungal infection of the finger- or toenails. It is one of the most frequent diseases of the body surface.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    • 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.
    • 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.
    • Evaluation of safety and tolerability of PD P 506 A photodynamic therapy of DSO of the great toenail(s).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male patients, 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 will be confirmed 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of nails with Clinically Complete Cure (CCR; clinically complete clear nail).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after the last study treatment
    E.5.2Secondary end point(s)
    • Photo documentation.
    • Percentage of nails with negative result after 12 months using laboratory methods (KOH test, periodic acid-Schiff (PAS) stain and mycology culture).
    • Percentage of nails with CCR after 3 and 6 months of treatment.
    • Frequency and severity of adverse events and local tolerability signs/symptoms.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6 and 12 months of treatment (see above).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-03-02
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