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    Summary
    EudraCT Number:2020-000851-11
    Sponsor's Protocol Code Number:W00118CR401
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-04
    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 number2020-000851-11
    A.3Full title of the trial
    Frequency and Intensity of local reactions in patients treated with 4% 5-FU vs 4% 5-FU associated with an emollient cream: a randomised, controlled clinical trial
    Fréquence et Intensité des réactions locales chez les patients traités avec du 5-FU à 4 % comparé au 5-FU à 4 % associé à une crème émolliente dans un essai clinique randomisé et contrôlé
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Frequency and Intensity of local reactions in patients treated with 4% 5-FU vs 4% 5-FU associated with an emollient cream: a randomised, controlled clinical trial
    Fréquence et Intensité des réactions locales chez les patients traités avec du 5-FU à 4 % comparé au 5-FU à 4 % associé à une crème émolliente dans un essai clinique randomisé et contrôlé
    A.3.2Name or abbreviated title of the trial where available
    TOLAK
    A.4.1Sponsor's protocol code numberW00118CR401
    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 SponsorPierre Fabre Dermatologie
    B.1.3.4CountryFrance
    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 supportPierre Fabre Dermatologie
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKatholisches Klinikum Bochum gGmbH
    B.5.2Functional name of contact pointNational Coordination center
    B.5.3 Address:
    B.5.3.1Street AddressGudrunstraße 56
    B.5.3.2Town/ cityBochum
    B.5.3.3Post code44791
    B.5.3.4CountryGermany
    B.5.4Telephone number+49234509 6052
    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 Tolak 40 mg/g Creme
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Dermo-Kosmetik GmbH
    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 Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFluorouracil
    D.3.9.3Other descriptive nameFLUOROURACIL
    D.3.9.4EV Substance CodeSUB07721MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    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.IMP: 2
    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 Dexeryl
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre
    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.3.1Product nameDexeryl
    D.3.4Pharmaceutical form Cream
    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 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
    Actinic keratosis with 5 or more clinically recognizable (palpable and/or visible to unaided eye) AK lesions of the face, and/or ears and/or scalp. The lesions must be clinically typical non hypertrophic and/or nonhyperkeratotic.
    Kératose actinique avec au moins 5 lésions cliniquement reconnaissables (palpables et / ou visibles à l'œil nu) du visage et / ou des oreilles et / ou du cuir chevelu. Les lésions doivent être cliniquement typiques non hypertrophiques et / ou non hyperkératosiques.
    E.1.1.1Medical condition in easily understood language
    Actinic keratosis
    Kératose actinique
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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
    The main study objective is to assess the frequency and the intensity of the local skin reactions at the end of the treatment course (or before in case of patient withdrawal).
    L'objectif principal de l'étude est d'évaluer la fréquence et l'intensité des réactions cutanées locales à la fin du traitement (ou avant en cas de retrait du patient).
    E.2.2Secondary objectives of the trial
    The other objectives are to evaluate the drop-outs due to AEs related to local skin reactions, the general safety and the clinical efficacy by the investigator.
    Patients will evaluate the treatment satisfaction (acceptability), the treatment adherence and the health-related quality of life during the treatment.
    Les autres objectifs sont d'évaluer les abandons dus aux EI liés aux réactions cutanées locales, la tolérance générale et l'efficacité clinique par l'investigateur.
    Les patients évalueront la satisfaction au traitement (acceptabilité), l'observance du traitement et la qualité de vie liée pendant le traitement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible only if all of the following criteria apply:
    Age
    1. Participant must be more than 18 years old inclusive, at the time of signing the informed consent.
    Type of Participant and Disease Characteristics
    2. Individuals with a clinical diagnosis of actinic keratosis (AK).
    3. Individuals harboring 5 or more clinically recognizable (palpable and/or visible to unaided eye) AK lesions of the face, and/or ears and/or scalp. The AK lesions must be clinically typical non hypertrophic and/or nonhyperkeratotic.
    4. Subject in good general condition and free of any disease state or condition which, in the investigator's opinion, could impair evaluation of actinic keratosis or could expose the subject to an unacceptable risk by study participation.
    Sex
    5. Male or female.
    A Female participant is eligible to participate if she is not a woman of childbearing potential (WOCBP), defined as postmenopausal (cessation of menses >12 months) or surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, total hysterectomy).

    Informed Consent
    6. Capable of giving signed informed consent as described in Appendix 1: Regulatory, Ethical, and Study Oversight Considerations, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    Ethical/Legal considerations
    7. Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation).
    Les participants ne sont éligibles que si tous les critères suivants s'appliquent:
    Âge
    1. Le participant doit être âgé de plus de 18 ans inclus, au moment de la signature du consentement éclairé.
    Type de participant et caractéristiques de la maladie
    2. Les personnes avec un diagnostic clinique de kératose actinique (KA).
    3. Les personnes présentant au moins 5 lésions AK cliniquement reconnaissables (palpables et / ou visibles à l'œil nu) du visage et / ou des oreilles et / ou du cuir chevelu. Les lésions AK doivent être cliniquement typiques non hypertrophiques et / ou non hyperkératosiques.
    4. Sujet en bon état général et exempt de tout état pathologique ou condition qui, de l'avis de l'investigateur, pourrait nuire à l'évaluation de la kératose actinique ou exposer le sujet à un risque inacceptable en participant à l'étude.
    Sexe
    5. Homme ou femme.
    Une participante est éligible à participer si elle n'est pas une femme en âge de procréer (WOCBP), définie comme ménopausée (arrêt des règles> 12 mois) ou chirurgicalement stérile (antécédents de ligature des trompes bilatérale, ovariectomie bilatérale, hystérectomie totale).

    Consentement éclairé
    6. Capable de donner un consentement éclairé signé comme décrit dans l'annexe 1: Considérations réglementaires, éthiques et de supervision de l'étude, qui comprend le respect des exigences et des restrictions énumérées dans le formulaire de consentement éclairé (ICF) et dans ce protocole.
    Considérations éthiques / juridiques
    7. Affilié à un système de sécurité sociale, ou est un bénéficiaire (si applicable dans la réglementation nationale).
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Medical Conditions
    1. With AK lesions within treatment areas which are hyperkeratotic or which are clinically suspected to be squamous cell carcinoma (SCC).
    2. With pre-existing local skin reactions with a total score ≥ 3.
    3. History of hypersensitivity to the ingredients of Tolak® or Dexeryl®.
    4. With a known allergy to peanut or soya.
    5. Non postmenopausal or non surgically sterile woman considered as WOCBP, pregnant or breastfeading women.
    Prior/Concomitant Therapy
    6. Under systemic 5-fluorouracil or any systemic cancer treatment within eight weeks prior to the study.
    7. Under any other topical AK treatments or therapies (e.g., Cryotherapy or Photodynamic therapy) in the treatment area(s) within eight weeks prior to starting the study.
    8. Treated with systemic steroids, immunosuppressants or immunomodulators within four weeks prior to the study.
    9. Under prescription retinoids or topical steroids in the treatment area(s) within four weeks prior to the study.
    10. With known dihydropyrimidinedehydrogénase (DPD) deficiency or under treatment with brivudine, sorivudine or analogues within 4 weeks prior to starting the study.
    11. Treated with glycolic acid products and alpha-hydroxy products in the treatment area(s) within four weeks prior to starting the study.
    12. Treated with chemical peeling products in the treatment area(s) within eight weeks prior to starting the study.
    Prior/Concurrent Clinical Study Experience
    13. Is participating in another clinical trial
    14. Has participated in another clinical trial within the last 30 days, has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial
    Other Exclusions
    15. Is a family member of the Investigator or any associate, colleague, and employee assisting in the conduct of the study (secretary, nurse, technician,…)
    16. Is in a position likely to represent a conflict of interest
    17. Has forfeited his / her freedom by administrative or legal award or is under guardianship
    Les participants sont exclus de l'étude si l'un des critères suivants s'applique:
    Les conditions médicales
    1. Avec des lésions AK dans les zones de traitement qui sont hyperkératosiques ou qui sont cliniquement suspectées d'être un carcinome épidermoïde (SCC).
    2. Avec des réactions cutanées locales préexistantes avec un score total ≥ 3.
    3. Antécédents d'hypersensibilité aux ingrédients de Tolak® ou Dexeryl®.
    4. Avec une allergie connue à l'arachide ou au soja.
    5. Femme non ménopausée ou non chirurgicalement stérile considérée comme WOCBP, femme enceinte ou allaitante.
    Thérapie antérieure / concomitante
    6. Sous 5-fluorouracile systémique ou tout autre traitement systémique contre le cancer dans les huit semaines précédant l'étude.
    7. Dans le cadre de tout autre traitement ou thérapie topique d'AK (par exemple, cryothérapie ou thérapie photodynamique) dans la ou les zones de traitement dans les huit semaines précédant le début de l'étude.
    8. Traités avec des stéroïdes systémiques, des immunosuppresseurs ou des immunomodulateurs dans les quatre semaines précédant l'étude.
    9. Sous prescription de rétinoïdes ou de stéroïdes topiques dans la ou les zones de traitement dans les quatre semaines précédant l'étude.
    10. Avec un déficit connu en dihydropyrimidinedehydrogénase (DPD) ou sous traitement par brivudine, sorivudine ou analogues dans les 4 semaines précédant le début de l'étude.
    11. Traités avec des produits à base d'acide glycolique et des produits alpha-hydroxy dans la ou les zones de traitement dans les quatre semaines précédant le début de l'étude.
    12. Traités avec des produits de peeling chimiques dans la ou les zones de traitement dans les huit semaines précédant le début de l'étude.
    Expérience d'études cliniques antérieures / simultanées
    13. Participe à un autre essai clinique
    14. A participé à un autre essai clinique au cours des 30 derniers jours, a reçu un traitement avec des effets résiduels connus ou a fait l'objet d'une enquête susceptible d'interférer avec le présent essai clinique
    Autres exclusions
    15. Est-ce un membre de la famille de l'enquêteur ou de tout associé, collègue et employé participant à la conduite de l'étude (secrétaire, infirmière, technicien,…)
    16. Est susceptible de représenter un conflit d'intérêts
    17. A perdu sa liberté par décision administrative ou judiciaire ou est sous tutelle
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this trial is the Local Skin Reaction (LSR) total score
    Le critère d'évaluation principal de cet essai est le score total de réaction cutanée locale (LSR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    at W4, or at an optional visit (LOCF) in case of major local reactions.
    après 4 semaines, ou lors d'une visite facultative (LOCF) en cas de réactions locales majeures.
    E.5.2Secondary end point(s)
    The secondary outcomes will be the following:
    Tolerability:
    • Local skin reactions: LSR total score at week 2 and Weekweek 8;
    • LSR items alone at each visit (see below): presence/absence and intensity;
    • Local reactions CTCAE grade 3 or 4.
    Other safety evaluations:
    • Other AEs reported by patients or noticed by investigator (see section 8.4 AE and SAE of the protocol);
    • Drop outs due to AE related to local skin reactions (discontinuation rate);
    • Use of rescue treatment (TCS).
    AE will be collected during the whole study period from signature of informed consent up to week 8 (W8) or premature withdrawal. Any clinical findings obtained during the study, will be followed until the condition returns to normal or stabilized.
    Patient reported outcomes:
    • Subjective signs at each visit: prurit (0-3), stinging/burning (0-3), pain (0-4);
    • Treatment satisfaction (acceptability): measured by TSQM-9 (treatment satisfaction questionnaire for medication) at W4 (end of treatment) or Patient Withdrawal (PW);
    • Treatment adherence: assessed by direct questioning of the participant by the investigatorusing a self questionnaire at W4; and Optional Visit (OV; when applicable);
    • Health-related quality of life: measured by AKQoL (actinic keratosis quality of life questionnaire, for Spain and Germany only) at baseline and W8 (4 weeks off-treatment and change from baseline).

    Clinical response (efficacy): measured by
    • Rates of patients with complete and partial clearance rates (cCR, pCR) at W8 (4 weeks off-treatment);
    • Change and Percentage change in number of AK lesions from baseline to week 2 (W2), W4 and W8.
    At each visit, the investigator will count of all visible and/or palpable actinic keratosis lesions in the treatment area(s).
    Les résultats secondaires seront les suivants:
    Tolérance:
    • Réactions cutanées locales: score total LSR à la semaine 2 et à la semaine 8;
    • Les items LSR seuls à chaque visite (voir ci-dessous): présence / absence et intensité;
    • Réactions locales CTCAE grade 3 ou 4.
    Autres évaluations de sécurité:
    • Autres EI rapportés par les patients ou remarqués par l'investigateur (voir rubrique 8.4 EI et EIG du protocole);
    • Abandons dus à des EI liés à des réactions cutanées locales (taux d'abandon);
    • Utilisation d'un traitement de secours (TCS).
    Les EI seront collectés pendant toute la durée de l'étude depuis la signature du consentement éclairé jusqu'à la semaine 8 (S8) ou le retrait prématuré. Tous les résultats cliniques obtenus au cours de l'étude seront suivis jusqu'à ce que la condition revienne à la normale ou se stabilise.
    Résultats rapportés par les patients:
    • Signes subjectifs à chaque visite: prurit (0-3), picotement / brûlure (0-3), douleur (0-4);
    • Satisfaction au traitement (acceptabilité): mesurée par TSQM-9 (questionnaire de satisfaction au traitement pour les médicaments) à S4 (fin de traitement) ou au retrait du patient (PW);
    • Observance du traitement: évaluée par un interrogatoire direct du participant par l'investigateur à l'aide d'un auto-questionnaire à S4; et visite facultative (VO, le cas échéant);
    • Qualité de vie liée à la santé: mesurée par AKQoL (questionnaire sur la qualité de vie de la kératose actinique, pour l'Espagne et l'Allemagne uniquement) au départ et à S8 (4 semaines sans traitement et changement par rapport au départ).

    Réponse clinique (efficacité): mesurée par
    • Taux de patients avec des taux de clairance complète et partielle (cCR, pCR) à S8 (4 semaines sans traitement);
    • Changement et changement en pourcentage du nombre de lésions AK entre le départ et la semaine 2 (S2), S4 et S8.
    À chaque visite, l'investigateur comptera toutes les lésions de kératose actinique visibles et / ou palpables dans la ou les zones de traitement.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Detailed in E.5.2
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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
    Group 1: patients treated with Tolak alone, Group 2: Patients treated with Tolak + Dexeryl
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Last Visit Last Patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days30
    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: 56
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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)
    Since Tolak® and Dexeryl® are already approved and marketed as drug and medical device respectively, the investigator will have the possibility to prescribe Tolak® and Dexeryl® to his/her patient for a new course, after the end of the clinical study and the recommended time period between courses, if he/she believes it is the best course of action for the patient.
    Puisque Tolak® et Dexeryl® sont déjà approuvés et commercialisés respectivement comme médicament et dispositif médical, l'investigateur aura la possibilité de prescrire Tolak® et Dexeryl® à son patient, après la fin de l'étude clinique et après la période recommandée entre deux traitements, s'il pense que c'est la meilleure ligne de conduite pour le patient.
    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 Decision2020-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-01-31
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    The status of studies in GB is no longer updated from 1.1.2021
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