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    Summary
    EudraCT Number:2019-001419-21
    Sponsor's Protocol Code Number:RC19_0042
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-01
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2019-001419-21
    A.3Full title of the trial
    Optimization of skin preparation to reduce Cutibacterium acnes colonization in superficial and deep samples during prosthetic shoulder surgery in male patients
    Optimisation de la préparation cutanée pour réduire la colonisation à Cutibacterium acnes dans des prélèvements superficiels et profonds lors de la chirurgie prothétique de l'épaule chez l'homme
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimization of skin preparation to reduce Cutibacterium acnes colonization in superficial and deep samples during prosthetic shoulder surgery in male patients
    A.3.2Name or abbreviated title of the trial where available
    OPRICA
    A.4.1Sponsor's protocol code numberRC19_0042
    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 SponsorCHU de Nantes
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistère de la santé - DGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nantes
    B.5.2Functional name of contact pointDirection recherche, CHU de Nantes
    B.5.3 Address:
    B.5.3.1Street Address5, allée de l'île Gloriette
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44093
    B.5.3.4CountryFrance
    B.5.4Telephone number0033253482813
    B.5.5Fax number0033253482836
    B.5.6E-mailbp-prom-regl@chu-nantes.fr
    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 Cutacnyl 5%
    D.2.1.1.2Name of the Marketing Authorisation holderGALDERMA INTERNATIONAL
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Cutaneous use
    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
    Cutibacterium acnes infection in shoulder arthroplasty with males
    E.1.1.1Medical condition in easily understood language
    Cutibacterium acnes infection in shoulder arthroplasty with males
    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
    Evaluate the efficacy of daily application, during the 5 days preceding the procedure, of a 5% benzoyl peroxide topical treatment in the surgical skin incision area, on the reduction of Cutibacterium acnes bacterial load in the dermis of the approach to shoulder arthroplasty in men.
    Evaluer l'efficacité de l'application quotidienne, pendant les 5 jours qui précèdent l’intervention, d'un topique de peroxyde de benzoyle 5 % au niveau de la zone d'incision cutanée opératoire, sur la diminution de charge bactérienne à Cutibacterium acnes au niveau du derme de la voie d'abord d'une arthroplastie d'épaule chez l'homme.
    E.2.2Secondary objectives of the trial
    ● Evaluate, in the context of shoulder arthroplasty in men, the effectiveness of applying 5% benzoyl peroxide to the skin incision area during the 5 days preceding the operation, on :
    o the bacterial load of Cutibacterium acnes on the skin, fat and capsular level ;
    o incidence of Cutibacterium acnes infections within 2 years of surgery.
    ● Evaluate, in the context of a shoulder arthroplasty in humans, the efficacy of alcoholic iodine povidone 5% (antiseptic from the operating area to the operating room) on the cutaneous bacterial load with Cutibacterium acnes;

    ● Characterize the different strains of Cutibacterium acnes found at the phylotypic and genotypic level;
    ● Evaluate the skin tolerance of the application of 5% benzoyl peroxide gel.
    ●Evaluer, dans le cadre d'une arthroplastie d'épaule chez l'homme, l’efficacité de l'application de peroxyde de benzoyle 5 %, sur la zone d'incision cutanée, pendant les 5 jours qui précèdent l’intervention, sur :
    o Evaluer la charge bactérienne à Cutibacterium acnes au niveau cutané, graisseux et capsulaire sur la voie d’abord;
    o Evaluer l'incidence des infections à Cutibacterium acnes dans les 2 ans suivant la chirurgie.
    ● Evaluer, dans le cadre d'une arthroplastie d'épaule chez l'homme, l’efficacité de la povidone iodée alcoolique 5 % (antiseptie de la zone opératoire au bloc) sur la charge bactérienne cutanée à Cutibacterium acnes ;
    ● Caractériser sur le plan phylotypique et génotypique les différentes souches de Cutibacterium acnes retrouvées ;
    ● Evaluer la tolérance cutanée de l'application du gel de peroxyde de benzoyle 5 %.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male patients,
    Adult patients,
    Patient without a history of surgical intervention on the operated shoulder,
    Patient managed for glenohumeral, partial (cup or anatomical hemi-arthroplasty) or total (anatomical or inverted) glenohumeral arthroplasty placement for primary osteoarthritis, or secondary to necrosis, massive rotator cuff tear or old fracture.
    Patients affiliated to a social security system
    Patients who have given their informed and written consent
    E.4Principal exclusion criteria
    ● Patient with arthroplasty for resumption of previous shoulder surgery or failure of arthroplasty
    ● Patient with arthroplasty for acute trauma
    ● Patient on immunosuppressive drugs
    ● Patient with inflammatory rheumatism
    ● Patient with progressive cancer pathology
    ● Allergies or intolerances concerning the modalities of selected skin preparations (Povidone Iodine, cefazolin, hypersensitivity to benzoyl peroxide)
    ● Dermatological pathologies in the area to be treated
    ● Acne treatment in the area to be treated within four weeks before inclusion
    ● Patient without possible help from a third party for the application of Cutacnyl® 5% in the intervention group if necessary
    ● Major under guardianship
    ● Patient under the protection of justice
    ● Patient not covered by social security
    E.5 End points
    E.5.1Primary end point(s)
    Number of patients in each group (interventional: benzoyl peroxide 5% for 5 days or control) with a positive Cutibacterium acnes sample at the dermis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day of the intervention (Day 0)
    E.5.2Secondary end point(s)
    ● Average number of positive intraoperative Cutibacterium acnes samples taken at the cutaneous level before and after cutaneous antisepsis of the operating area before incision, fat and capsular. The skin sample at inclusion will allow the initial cutaneous Cutibacterium acnes bacterial load to be compared between both groups;
    ● Average number of positive Cutibacterium acnes skin samples before and after alcoholic surgical site antisepsis (5% alcoholic iodine povidone) in each of the two study groups;
    ● Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups;
    ● Determination of phylotype, molecular typing by Multi-Locus Sequence Typing and Single-Locus Sequence Typing techniques and comparison of Cutibacterium acnes strains by molecular biology and characterization of antibiotic resistance;
    ● Evaluation of the skin tolerance of the topical application from the local tolerance scale (irritation, erythema and desquamation), at the time of inclusion and at D0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ● Day 0
    ● Day 0
    ● 2 years
    ● Day 0
    ● Day 0
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Blinded endpoint
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    no intervention
    E.8.2.4Number of treatment arms in the trial2
    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 concerned12
    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
    Last visit of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female No
    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 state110
    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)
    At the end of the study, patients willreceive appropriate routine medical care related to their condition based on local procedure
    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 Decision2019-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-18
    P. End of Trial
    P.End of Trial StatusOngoing
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