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    Summary
    EudraCT Number:2011-003295-37
    Sponsor's Protocol Code Number:V00034CR3121B
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-18
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2011-003295-37
    A.3Full title of the trial
    Efficacy of the V0034CR01B emollient on xerosis in children with atopic dermatitis. Randomised, vehicle-controlled, parallel-groups, double-blind study with an open label extension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of the V0034CR01B emollient on xerosis in children with atopic dermatitis. Randomised, vehicle-controlled, parallel-groups, double-blind study with an open label extension
    A.4.1Sponsor's protocol code numberV00034CR3121B
    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, cream
    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 V0034CR01B
    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.3.9.3Other 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCream
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    xerosis in children with atopic dermatitis
    E.1.1.1Medical condition in easily understood language
    skin dryness
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    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
    To demonstrate the efficacy of V0034CR01B cream on xerosis in children with atopic dermatitis.
    E.2.2Secondary objectives of the trial
    To document the impact of the absence and the reintroduction of emollient treatment.
    To document the clinical (local and systemic) safety of the treatment over the study duration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age between 2 and 6 years included,
    - Presenting with atopic dermatitis according to the diagnostic criteria of the UK Working Party,
    - With xerosis on the body and a xerosis score > 2 (SCORAD sub-score) on the anterior part of lower limbs,
    - Whose objective SCORAD score is < 15 at inclusion,
    - Associated signs such as hyperlinearity in the palms and/or scales on the lower limbs,
    - 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).
    E.4Principal exclusion criteria
    Criteria related to pathologies
    - Acute phase of atopic dermatitis with moderate/severe erythema, mild/moderate/sever excoriation, crust, oozing or exudation,
    - 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,
    - History of hypersensitivity or intolerance to one of the components of the tested or associated products, or to cosmetics,
    - 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, 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).

    Criteria related to the population
    - Child with a brother or sister already included in this study,
    - Patient and/or parent(s) or guardian(s) linguistically or psychologically unable to understand the information given or give his/her(their) informed consent or who refuses(refuse) to give his/her(their) consent in writing,
    - Parent(s) or guardian(s) subject to an administrative or court order or subject to guardianship or wardship,
    - Parent(s) or guardian(s) who cannot be contacted by telephone in an emergency,
    - Participation to another clinical trial or being in the exclusion period of another clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    Xerosis score: mean evolution over the different time-points of double-blind period D1–D28 (D7, D14, D21 and D28).
    E.5.1.1Timepoint(s) of evaluation of this end point
    D7, D14, D21 and D28
    E.5.2Secondary end point(s)
    Double-blind period:
    - Xerosis score: evolution at the different time-points of double-blind period D1–D28 (D7, D14, D21 and D28).
    - Xerosis VAS: evolution at D14 and D28.
    - Xerosis measured by the corneometer: Hydration Index (HI) evolution at D14 and D28.
    - Evolution of Objective SCORAD at D28.
    - Number of responders to treatment (patients who decrease the grade in xerosis score and whose objective SCORAD is lower than their objective SCORAD at baseline) and non responders to treatment at D28.
    Exploratory criteria
    - Number of days of application of the moderately potent corticosteroid.
    Open-label period:
    - In patients treated with V0034CR01B: the evolution of xerosis score, xerosis VAS, HI, objective SCORAD and the number of responders to treatment (patients who decrease the grade in xerosis score and those objective SCORAD is lower then objective SCORAD at baseline) at D56 and D84.
    - In non treated follow-up patients: the evolution of xerosis score, xerosis VAS, HI, objective SCORAD and the number of failures at D56 and D84.
    Global evaluations:
    - Overall assessment of treatment efficacy by the investigator on a 4 point scale at the end double-blind period D28 and at the end of open-label period at D84 (only for patients treated with V0034CR01B).
    - Overall assessment of treatment efficacy by the parents on a 4 point scale at the end double-blind period D28 and at the end of open-label period at D84 (only for patients treated with V0034CR01B).
    - Overall assessment of treatment use by the parents on a 4 point scale at the end double-blind period D28 and at the end of open-label period at D84 (only for patients treated with V0034CR01B).
    Safety evaluations:
    - Assessment of the local tolerability (examination of the skin) and the systemic safety (general clinical examination and reported adverse events).
    E.5.2.1Timepoint(s) of evaluation of this end point
    D7, D14, D21, D28 (double-blind)
    D56, D84 (open-label)
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    The end of study is the date of the last visit of the last patient undergoing the trial.
    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 months8
    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 months8
    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: 232
    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: 232
    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)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 232
    F.4.2.2In the whole clinical trial 232
    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 applicable
    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 Decision2011-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-05-24
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