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    Summary
    EudraCT Number:2012-004621-24
    Sponsor's Protocol Code Number:V00034CR3131B
    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:2013-06-27
    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 number2012-004621-24
    A.3Full title of the trial
    Emollients in the management of atopic dermatitis in children: prevention of flares.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Emollients in the management of atopic dermatitis in children: prevention of flares.
    A.3.2Name or abbreviated title of the trial where available
    Emollients in the management of AD
    A.4.1Sponsor's protocol code numberV00034CR3131B
    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 MEDICAMENT
    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 MEDICAMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPIERRE FABRE MEDICAMENT
    B.5.2Functional name of contact pointCarine FABRE
    B.5.3 Address:
    B.5.3.1Street Address3 avenue Hubert Curien
    B.5.3.2Town/ cityTOULOUSE
    B.5.3.3Post code31035
    B.5.3.4CountryFrance
    B.5.4Telephone number+33534506357
    B.5.5Fax number+33534506592
    B.5.6E-mailcarine.fabre@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 DEXERYL
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE MEDICAMENT
    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.3.2Product code V0034CR
    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 INNGlycerol
    D.3.9.1CAS number 56-81-5
    D.3.9.3Other descriptive nameGLYCEROL
    D.3.9.4EV Substance CodeSUB07948MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNWhite soft paraffin
    D.3.9.1CAS number 8000026-37-1
    D.3.9.3Other descriptive nameWHITE SOFT PARAFFIN
    D.3.9.4EV Substance CodeSUB15722MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPARAFFIN LIQUID
    D.3.9.2Current sponsor codeV0049
    D.3.9.3Other descriptive nameParaffin liquid
    D.3.9.4EV Substance CodeSUB30031
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Atopic dermatitis
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the ability of DEXERYL to prevent flares after treatment of a previous flare by a topical corticosteroid.
    E.2.2Secondary objectives of the trial
    To assess the time to first flare, the number of flares
    To evaluate the consumption of topical corticosteroid
    To evaluate DEXERYL effect on the skin dryness and pruritus
    To evaluate DEXERYL on the subjective perception of the skin
    To document the clinical, local and systemic, safety of DEXERYL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients, male or female children, presenting with the following criteria may be included (V1):
    Age between 2 and 6 years included,
    - Presenting with atopic dermatitis according to the diagnostic criteria of the UK Working Party,
    - Who has presented within the previous 6 months at least one duly documented flare treated by corticosteroids,
    - Who present a current flare,
    - Whose objective SCORAD score is [15-40] (grade 3) at inclusion,
    - Whose parent(s) or guardian(s) has given his/her (their) written consent for their child's participation in the study,
    - Whose parent(s) or guardian(s) is (are) cooperative with regard to compliance with study-related constraints,
    - Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation).
    After treatment of the current flare, patients should have for randomization (V2):
    - Objective SCORAD score is < 15,
    - No lichenification, no excoriation, no oozing/crusts, no oedema/papulation,
    - Erythema intensity < 1 (residual erythema area ≤ 10% of extent),
    - Xerosis intensity> 1,
    - No pruritus, no sleep disorders (< 1 on VAS of SCORAD).
    If lesions are not cleared in 21 days, patient cannot be randomized.
    E.4Principal exclusion criteria
    * Criteria related to pathologies
    - Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation,
    - Primary bacterial, viral, fungal or parasitic skin infection,
    - Ulcerated lesions, acne or rosacea,
    - Dermatological disease other than atopic dermatitis which could interfere with the assessment,
    - Immunosuppression,
    - History of serious disease considered by the investigator hazardous for the patient or incompatible with the study.
    * Criteria related to treatments
    - Use of oral corticosteroids or immunosuppressants during the last 14 days,
    - Use of topical corticosteroids during the last 7 days,
    - Use of systemic or local antibiotics on the lesions during the last 7 days,
    - Use of non-steroid anti-inflammatory drugs or antihistamines during the last 7 days,
    - Regular use of food supplements that could, in the opinion of the investigator, modify skin properties (e.g. synbiotics),
    - History of hypersensitivity or intolerance to one of the components of the tested or associated products, or to cosmetics.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with at least one flare assessed by the investigator over the 12 weeks of treatment
    In case of occurrence of flare, the patient should be seen as soon as possible by the investigator to confirm the flare, and if necessary to prescribe appropriate treatments.
    A flare will be defined as following : measurable increased extent or intensity of lesions in less than 2 weeks under continued treatment (in this case: emollient or no emollient), corresponding to a significant increase (> 25%) in medical score (SCORAD or last PO-SCORAD) or to the introduction of a new line of therapy (topical corticosteroid).
    E.5.1.1Timepoint(s) of evaluation of this end point
    D28, D56, D84
    E.5.2Secondary end point(s)
    • Time to first flare assessed by the investigator over the 12 weeks of treatment
    • Number of patients in complete remission defined as a period without flare of at least 8 weeks without anti-inflammatory treatment (avoidance of irritants / allergens and emollients not included)
    • Number of patients needing corticosteroids or immunosuppressants over the 12 weeks of treatment
    • Consumption of corticosteroid: number of days of application, weight of corticosteroid used
    • Xerosis score (from SCORAD) over the 12 weeks of treatment
    • Pruritus score (VAS from SCORAD) over the 12 weeks of treatment
    • Sleep loss score (VAS from SCORAD) over the 12 weeks of treatment
    • SCORAD and objective SCORAD scores assessed by the investigator at every visit over the 12 weeks of treatment
    • PO-SCORAD (Patient Oriented SCORAD) score assessed twice weekly by the parents over the 12 weeks of treatment
    • IGA (Investigator Global Assessment) assessed by the investigator at every visit over the 12 weeks of treatment
    • POEM score (Patient-Oriented Eczema Measure) assessed weekly by parents over the 12 weeks of treatment
    • Assessment of the local tolerability (examination of the skin) and the systemic safety (general clinical examination and reported adverse events).
    • Overall assessment of treatment use by the parents on a 4 point scale at 12th week (only for patients treated by one of 2 emollients).
    E.5.2.1Timepoint(s) of evaluation of this end point
    D28, D56, D84
    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) 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 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
    No treatment (arm n°2).Atopiclair (arm n°3) is a class IIa authorised MD used as a positive control.
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 409
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 409
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Consent is given by the parent(s) or guardian(s) beacause child aged 2 to 6.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 409
    F.4.2.2In the whole clinical trial 409
    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 Decision2013-01-21
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-12
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