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    Clinical Trial Results:
    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.)

    Summary
    EudraCT number
    2013-001753-26
    Trial protocol
    FR  
    Global end of trial date
    20 Feb 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    03 Mar 2019
    First version publication date
    03 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DC0984LE401
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pierre Fabre Dermo-Cosmétique
    Sponsor organisation address
    2 rue Viguerie, Toulouse, France, 31025
    Public contact
    Emmanuel QUESTEL, Pierre Fabre Dermo-cosmétique, +33 562488505, emmanuel.questel@pierre-fabre.com
    Scientific contact
    Emmanuel QUESTEL, Pierre Fabre Dermo-cosmétique, +33 562488505, emmanuel.questel@pierre-fabre.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Feb 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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.)
    Protection of trial subjects
    Cette étude a été réalisée chez le sujet dans le respect de la Déclaration d’Helsinki (1964) et de ses révisions successives, des Bonnes Pratiques Cliniques (CPMP/ICH/135/95) et de la réglementation française en vigueur. Le protocole et les documents associés (incluant le formulaire d’information et de consentement) ont été soumis au Comité de Protection des Personnes (CPP) du Sud-Ouest et Outre-Mer III (Bordeaux) et à l’Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) avant sa mise en oeuvre. Cette étude clinique a débuté qu’après avoir reçu l’avis favorable du CPP et l’autorisation de l’autorité compétente (ANSM).
    Background therapy
    En cas de survenue d’irritation trop importante, il pouvait être décidé comme indiqué dans le RCP (ces réactions sont normales tant qu'elles restent modérées, dans les limites de la tolérance individuelle et susceptibles de céder à une simple réduction de posologie) de réduire la posologie selon l’avis de l’investigateur. Le produit pouvait par exemple être temporairement appliqué 1 jour sur 2. Les sujets devaient réaliser leur toilette corporelle la veille au soir des visites et n’appliquer aucun produit de soin au niveau du dos entre cette toilette et la visite. Les sujets ne devaient pas exposer le dos au soleil ou aux UV artificiels. Les sujets ne devaient pas appliquer de produit topique par exemple : auto-bronzant, kératolytique ou exfoliant (hors produit d’hygiène) au niveau du dos. Les sujets devaient éviter les bains (baignoire, piscine…), sauna et hammam.
    Evidence for comparator
    L'évolution de la sécheresse cutanée a été mesurée sur la zone d'application de la lotion Locacid 0,1% ainsi que sur une zone témoin non traitée.
    Actual start date of recruitment
    01 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    24 sujets devaient être inclus dans l'étude afin d'avoir 20 sujets analysables. Les sujets sortis prématurément de l’étude n’étaient pas remplacés et ne pouvaient pas être à nouveau inclus dans l’étude.

    Pre-assignment
    Screening details
    24 sujets de sexe masculin, âgés de 18 à 30 ans, avec un phototype I à IV et 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)) ont été inclus dans l'étude.

    Period 1
    Period 1 title
    Traitement (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Investigator [1]

    Arms
    Arm title
    Sujets
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Locacid 0,1% (trétinoïne)
    Investigational medicinal product code
    Other name
    DC984
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    La lotion Locacid 0,1% a été utilisée à une posologie de 1 mg/cm² (9 gouttes) sur une zone de 12cmx12cm au niveau du haut du dos sur une durée de traitement de 21 jours dont 15 d'application du produit. Le produit était appliqué une fois par jour (5j/sem) par une technicienne de recherche clinique. En cas de survenue d’irritation trop importante, il pouvait être décidé comme indiqué dans le RCP (ces réactions sont normales tant qu'elles restent modérées, dans les limites de la tolérance individuelle et susceptibles de céder à une simple réduction de posologie) de réduire la posologie selon l’avis de l’investigateur. Le produit pouvait par exemple être temporairement appliqué 1 jour sur 2.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The subject was aware of the treated zone of his back whereas the investigatorwasn't as the product was applied by a technician and remained blinded.
    Number of subjects in period 1
    Sujets
    Started
    24
    Completed
    22
    Not completed
    2
         Protocol deviation
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Traitement
    Reporting group description
    -

    Reporting group values
    Traitement Total
    Number of subjects
    24 24
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    24 24
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    25.63 (19 to 30) -
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    24 24
    Phototype
    Classification selon Fitzpatrick
    Units: Subjects
        II
    4 4
        III
    19 19
        IV
    1 1
    Etat cutané du dos à l'inclusion
    Units: Subjects
        Absence de caractéristique dermatologique
    22 22
        Cicatrice hypopigmentée
    1 1
        Tatouage en dehors des zones à l'étude
    1 1
    Cotation clinique de l'acné du dos (socre IGA)
    Units: Subjects
        Grade 0: Peau saine
    0 0
        Grade 1: Peau presque saine
    8 8
        Grade 2: Sévérité légère
    9 9
        Grade 3: Sévérité modérée
    7 7
        Grade 4: Sévère
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Sujets
    Reporting group description
    -

    Primary: Score SRRC (specified symptom sum score)

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    End point title
    Score SRRC (specified symptom sum score) [1]
    End point description
    Ce score comprend la cotation de la desquamation, de la rugosité, de la rougeur, et des fissures. Après vérification de la normalité des distributions, l'analyse primaire sera effectuée sur la FAS (Full Analysis Set n=22). Le critère principal portera sur l'évolution du score SRRC entre J1 et J22, et sur la comparaison de cette évolution entre les deux zones (traitée vs non traitée). L'analyse utilisée sera une analyse de covariance (ANCOVA) comportant les facteurs site, produit et séquence comme effet fixe, le facteur sujet comme effet aléatoire et la valeur à Baseline comme covariable. La distribution du critère SRRC n’est pas gaussienne, le test des rangs signés de Wilcoxon est utilisée afin de comparer les deux zones sur l’évolution J22-J1 et d’étudier l’évolution des deux zones. La comparaison inter-groupe met en évidence une différence d’évolution du score SRRC significative entre les 2 zones (p<0.0001).
    End point type
    Primary
    End point timeframe
    Le score SRRC déterminant la sécheresse cutanée a été mesuré lors du bilan de la visite 1 d'inclusion et lors de la visite 16 de fin d'étude (J22) pour chaque patient par l'investigateur.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been specified because the study is a single-arm study with intra-subjects control.
    End point values
    Sujets
    Number of subjects analysed
    22
    Units: not applicable
        Score=0
    0
        Score=1
    0
        Score=2
    1
        Score=3
    2
        Score=4
    3
        Score=5
    6
        Score=6
    4
        Score=7
    1
        Score=8
    2
        Score=9
    2
        Score=10
    1
    Attachments
    Evolution du score SRRC obtenue sur 22 sujets
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Les évènements indésirables ont été recueillis de l'inclusion du sujet jusqu'à la visite 16 (J22) de fin d'étude.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Safety set
    Reporting group description
    -

    Serious adverse events
    Safety set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Hematoma
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Safety set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 24 (100.00%)
    Injury, poisoning and procedural complications
    cutaneous lesion
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences all number
    2
    dental lesion
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Laryngeal pain
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Nervous system disorders
    Paresthesia
         subjects affected / exposed
    8 / 24 (33.33%)
         occurrences all number
    10
    Burning sensation
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    General disorders and administration site conditions
    Xerosis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Congenital cyst
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    fever
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Gastrointestinal disorders
    dental pain
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Skin exfoliation
         subjects affected / exposed
    21 / 24 (87.50%)
         occurrences all number
    30
    Pruritus
         subjects affected / exposed
    15 / 24 (62.50%)
         occurrences all number
    38
    Erytheme
         subjects affected / exposed
    24 / 24 (100.00%)
         occurrences all number
    105
    Dry skin
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    cutaneous dryness
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Rash papulosquamous
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Papule
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Scab
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Urticaria cholinergic
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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