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    Summary
    EudraCT Number:2016-003997-41
    Sponsor's Protocol Code Number:RC16_0019
    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:2017-10-20
    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 number2016-003997-41
    A.3Full title of the trial
    Controlled and double blind comparison of a traditional dressing versus a biologic dressing composed of fetal fibroblasts and keratinocytes in association with a collagen matrix on skin donor sites
    Pansement biologique composé de fibroblastes et de kératinocytes fœtaux en association avec une matrice de collagène
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Controlled and double blind comparison of a traditional dressing versus a biologic dressing composed of fetal fibroblasts and keratinocytes in association with a collagen matrix on skin donor sites
    Pansement biologique composé de fibroblastes et de kératinocytes fœtaux en association avec une matrice de collagène
    A.3.2Name or abbreviated title of the trial where available
    CICAFAST
    A.4.1Sponsor's protocol code numberRC16_0019
    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 supportDGOS
    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 de la Recherche
    B.5.3 Address:
    B.5.3.1Street Address5, allée de l'Ile Gloriette
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44093
    B.5.3.4CountryFrance
    B.5.4Telephone number0033253482884
    B.5.5Fax number0033253482836
    B.5.6E-maildamien.fairier@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 No
    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.3.1Product nameCICAFAST
    D.3.4Pharmaceutical form Transdermal system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    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) Yes
    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
    Split thickness skin graft
    E.1.1.1Medical condition in easily understood language
    Split thickness skin graft
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10041667
    E.1.2Term Split thickness skin graft
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare wound healing of CICAFAST versus conventional treatment (JELONET®) in the treatment of STSG donor site at D8.
    E.2.2Secondary objectives of the trial
    Evaluate the concordance between the healing at D8 (or D11 and D15) judged by blind physician observer and the evaluation of healing by two experts using photographs
    Compare wound healing’s rapidity of CICAFAST versus conventional treatment (JELONET®) in the treatment of STSG donor site.
    Evaluate the tolerance of CiCAFAST versus the conventional treatment (JELONET®)
    Compare the pain of the wound healing with CICAFAST versus conventional treatment (JELONET®)
    Compare the quality of the wound healing with CICAFAST versus conventional treatment (JELONET®)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Female or male aged ≥18 years old
    For potentially childbearing female effective contraception is required
    Patient who need skin graft ( height from 100cm2 to 200cm2 and thickness 1.2mm) after surgery excision
    Patients with social security
    Patients able to understand and follow the trial instructions
    Patients who have signed an informed consent
    E.4Principal exclusion criteria
    Patients suffering from uncontrolled metabolic disease ( for instance diabete), from a psychiatric disorder not treated, with severe arteritis of lower and/or upper limbs, treated with anticoagulant (unless treatment stop 7 days before the surgery), with severe venous insufficiency, suffering of severe polyneuropathy, with known allergy to bovine protein, receiving corticosteroids, immunosuppressive or cytotoxic agents
    Grade 2, 3 or 4 infections at the inclusion visit
    Patient intolerant to the conventional treatment (JELONET®)
    Patient intolerant to the stretchable strip (NYLEX®)
    Pregnant or breast-feeding women
    Patients participating in interventional clinical trial
    Vulnerable people : persons deprived of liberty; under trusteeship or under curatorship
    E.5 End points
    E.5.1Primary end point(s)
    The number of complete healing at D8 judged by blind physician observer. Healing is defined as 80% or more wound closure (determined by a ruler).
    E.5.1.1Timepoint(s) of evaluation of this end point
    D8
    E.5.2Secondary end point(s)
    • The healing at D8 (or D11 and D15) judged by blind experts on picture. Healing is defined as 80% or more wound closure
    • Time to healing (in days) judged by blind physician observer
    • AE notification: case of infection (patients with 1 or 2 infections controlled by antibiotherapy will stay in the study. Patients with grade 3 or 4 infection will be withdrawn from the trial) and case of biological dressing (CICAFAST) rejection.
    • Evaluation of the quality of the wound healing by an observer (physician who will not do the patient surgery) at M3 and M6, OSAS scale will be used, by the patient (PSAS scale will be used) and blind expertise on picture by 2 external experts (Visual Analogue Scale 1 like normal skin to 10 the worst scar) and the results of scars’confocal microscopy at M3. A second evaluation of complete healing will be performed by two exterior independent experts evaluating the photographs taken until complete healing (Healing is defined as 80% or more wound closure).
    • Number of painful day/wound from the surgery until the complete healing
    E.5.2.1Timepoint(s) of evaluation of this end point
    D8, D11, D15, M3 and M6
    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) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    JELONET: paraffin gauze dressing
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Yes
    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 years
    E.8.9.1In the Member State concerned months18
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state38
    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)
    Not different from the expected normal treatment of that condition
    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 Decision2017-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-09
    P. End of Trial
    P.End of Trial StatusOngoing
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