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    The EU Clinical Trials Register currently displays   42570   clinical trials with a EudraCT protocol, of which   7009   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-001753-26
    Sponsor's Protocol Code Number:DC0984LE401
    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:2015-09-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2013-001753-26
    A.3Full title of the trial
    Clinical and biophysics evaluation of the cutaneous modifications following the local use of a lotion containing 0,1 % of trétinoïne.
    Evaluation clinique et biophysique des modifications cutanées secondaires à l’utilisation locale d’une lotion contenant 0,1% de trétinoïne.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the cutaneous modifications following the local use of an anti acneic lotion.
    Evaluation des modifications cutanées secondaires à l’utilisation locale d’une lotion anti-acnéique.
    A.4.1Sponsor's protocol code numberDC0984LE401
    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 Dermo-cosmétique
    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 Dermo-cosmétique
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPierre Fabre Dermo-cosmétique
    B.5.2Functional name of contact pointQUESTEL
    B.5.3 Address:
    B.5.3.1Street AddressCentre de Recherche sur la Peau, 2 rue Viguerie, BP 3071, Cedex 3
    B.5.3.2Town/ cityTOULOUSE
    B.5.3.3Post code31025
    B.5.3.4CountryFrance
    B.5.4Telephone number33562488505
    B.5.5Fax number33562488599
    B.5.6E-mailemmanuel.questel@pierre-fabre.com
    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 LOCACID 0.1% lotion
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Dermatologie
    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 Cutaneous liquid
    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 INNtretinoin
    D.3.9.1CAS number 302-79-4
    D.3.9.4EV Substance CodeSUB11246MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    Acne
    Acné
    E.1.1.1Medical condition in easily understood language
    Acne
    Acné
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10000497
    E.1.2Term Acnes
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10000496
    E.1.2Term Acne
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level SOC
    E.1.2Classification code 10040785
    E.1.2Term Skin and subcutaneous tissue disorders
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLGT
    E.1.2Classification code 10040798
    E.1.2Term Skin appendage conditions
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Measure the evolution on 21 days of the skin dryness consecutive to the local application of trétinoïne treatment compared with an untreated zone.
    Mesurer l’évolution sur 21 jours de la sécheresse cutanée consécutive à l’application locale d’un traitement à base de trétinoïne comparativement à une zone témoin non traitée.
    E.2.2Secondary objectives of the trial
    Measure by clinical, biometrological, spectroscopiques, biochemical, molecular and illustrative methods, some criterion associated to the skin dryness consecutive to the local application of a trétinoïne treatment.
    Mesurer par des méthodes cliniques, biométrologiques, spectroscopiques, biochimiques, moléculaires et illustratives, différents critères associés à la sécheresse cutanée consécutive à l’application locale d’un traitement à base de trétinoïne.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Relative to the population:
    O male Adult.
    O Age included between 18 and 30 inclusive years.
    O Phototype I to IV
    o Pilosity reduced at the level of the top of the back
    o Subject affiliated to a French national insurance scheme,
    o Subject having given its written consent to its participation in the study.
    O Registration in the national file of the persons who lend themselves to biomedical researches.

    Relative to the pathology:
    Subject having a moderated acne at the level of the back, the evaluation by the investigator global assessment of the acne (rank 1, 2, 3)
    Relatifs à la population :
    o Adulte de sexe masculin.
    o Age compris entre 18 et 30 ans inclus.
    o Phototype I à IV
    o Pilosité réduite au niveau de la partie supérieure du dos
    o Sujet affilié à un régime de sécurité sociale français,
    o Sujet ayant donné son consentement écrit à sa participation à l’étude.
    o Inscription au fichier national des personnes qui se prêtent à des recherches biomédicales.

    Relatifs à la pathologie :
    Sujet ayant une acné minime à modérée au niveau du dos, évaluation par l’investigateur sur une échelle classique globale de l’acné (grade 1, 2, 3)
    E.4Principal exclusion criteria
    Relative to the pathologies:
    · Any dermatological pathology on the back, other than the acne.
    · Existence of a chronic affection or an evolutionary acute pathology which can interfere with the study.

    Relative to treatments:
    · Use of a self-tanning, keratolytic or exfoliating product on the back in 2 weeks preceding the inclusion.
    · Use on the back of any product which can interfere with the study (produced moisturizer, care product) in 2 weeks preceding the inclusion.
    · Treatment by oral route by antibiotics in 2 weeks preceding the inclusion.
    · Treatment by oral route by anti-inflammatory or corticoid during more than 2 consecutive days in 2 weeks preceding the inclusion.
    - Treatment by local use on the study zone : by anti-inflammatory, corticoid or antibiotics during more than 2 consecutive days in 2 weeks preceding the inclusion.
    · Hormonal treatment (in thyroid, anti-acned) by oral route in two months preceding the inclusion.
    · Any anti-acned treatment:
    O By local use on the study zone (acid azélaique, peroxide of benzoyle, antibiotics, rétinoïdes) in the month preceding the beginning of the study,
    o By oral use: antibiotics (tétracyclines or macrolides) or zinc in the month preceding the beginning of the study,
    o By oral use: rétinoïdes in 6 months preceding the beginning of the study.
    · Allergy or for intolerance in one of the components of the LOCACID lotion ®.
    · Histories known for allergy or intolerance to the latex.

    Relative to the population:
    · Exposure the back to the sun planned during the study.
    · Presence on the experimental zone of solar erythema or other mark which can interfere with the evaluation of the cutaneous reactions (pigmentation disorders, tattoo).
    · Participation in a clinical trial on the back in the week preceding the inclusion.
    · Subject in the impossibility to conform to theprotocol requirements.
    · Subject having perceived, within the framework of clinical trials, compensations superior to 4 500 euros, this included study, during the last 12 months.
    · Subject in incapacity to understand the information (for linguistic or psychiatric causes) and to give its consent.
    • Subject confiscated his liberty by administrative or legal decision or guardianship.
    · Subject which participates at present or which participated in another clinical trial and being in period of exclusion during which he can not participate to another clinical trial.
    Relatifs aux pathologies :
    • Toute pathologie dermatologique au niveau du dos, autre que l’acné.
    • Existence d’une affection chronique ou d’une pathologie aiguë évolutive pouvant interférer avec l’étude.

    Relatifs aux traitements :
    • Utilisation d’un produit auto-bronzant, kératolytique ou exfoliant au niveau du dos dans les 2 semaines précédant l’inclusion.
    • Utilisation au niveau du dos de tout produit pouvant interférer avec l’étude (produit hydratant, produit de soin,…) dans les 2 semaines précédant l’inclusion.
    • Traitement par voie orale par antibiotiques dans les 2 semaines précédant l’inclusion.
    • Traitement par voie orale par anti-inflammatoires ou corticoïdes pendant plus de 2 jours consécutifs dans les 2 semaines précédant l’inclusion.
    • Traitement par voie locale sur la zone à l’étude par anti-inflammatoires, corticoïdes ou antibiotiques pendant plus de 2 jours consécutifs dans les 2 semaines précédant l’inclusion.
    • Traitement hormonal (à visée thyroïdienne, anti-acnéique) par voie orale dans les deux mois précédant l’inclusion.
    • Tout traitement anti-acnéique :
    o Par voie locale sur la zone à l’étude (acide azélaique, peroxyde de benzoyle, antibiotiques, rétinoïdes...) dans le mois précédant le début de l’étude,
    o Par voie générale, par antibiotiques (tétracyclines ou macrolides) ou par le zinc dans le mois précédant le début de l’étude,
    o Par voie générale par rétinoïdes dans les 6 mois précédant le début de l’étude.
    • Antécédents connus d’allergie ou d’intolérance à un des composants du LOCACID lotion®.
    • Antécédents connus d’allergie ou d’intolérance au latex.

    Relatifs à la population :
    • Exposition solaire du dos prévue pendant l’étude.
    • Présence sur la zone expérimentale d’érythème solaire ou autre marque pouvant interférer avec l'évaluation des réactions cutanées (troubles de la pigmentation, tatouage...).
    • Participation à une étude clinique au niveau du dos dans la semaine précédant l’inclusion.
    • Sujet dans l’impossibilité de se conformer aux exigences du protocole.
    • Sujet ayant perçu, dans le cadre d’études cliniques, des indemnités supérieures à 4 500 euros, cette étude comprise, au cours des 12 derniers mois.
    • Sujet en incapacité de comprendre l’information (pour des causes linguistiques ou psychiatriques) et de donner son consentement à la participation.
    • Sujet confisqué de sa liberté par décision administrative ou légale ou sous tutelle.
    • Sujet qui participe actuellement ou qui a participé à une autre étude clinique et se trouvant en période d’exclusion au cours de laquelle il ne peut participer à aucune autre recherche biomédicale.
    E.5 End points
    E.5.1Primary end point(s)
    SRRC score which measures the skin dryness at day 1 and day 22
    Score SRRC mesurant la sécheresse cutanée à Jour 1 et Jour 22
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 1 and day 22
    Jour 1 et Jour 22
    E.5.2Secondary end point(s)
    Some criterion linked to the skin dryness.
    Différents critères associés à la sécheresse cutanée.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, day 8, day 15, day 22
    Jour 1, Jour 8, Jour 15, Jour 22
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Clinical study: research and development
    Etude clinique : recherche et développement
    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 No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    controlatéral
    controlateral
    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 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 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
    LVLS
    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 months9
    E.8.9.1In the Member State concerned days0
    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: 24
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state24
    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 Decision2013-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-20
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