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    Summary
    EudraCT Number:2007-002182-12
    Sponsor's Protocol Code Number:W0153-09
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2007-05-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-002182-12
    A.3Full title of the trial
    A SINGLE CENTER, SINGLE-BLIND, PARALLEL GROUP CLINICAL TRIAL TO INVESTIGATE THE EFFICACY AND SAFETY OF W0153 VS. STANDARD MOISTURIZER IN THE MAINTENANCE OF PATIENTS WITH ATOPIC DERMATITIS
    A.4.1Sponsor's protocol code numberW0153-09
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorStiefel Laboratories
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Betnovate Cream
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKine UK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Information not present in EudraCT
    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 INNbetamethasone-17-valerate
    D.3.9.1CAS number 2152-44-5
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.122
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the Safety and Efficacy of medical device W0153 vs. standard moisturizer in maintaining clearance of symptoms in subjects with atopic dermatitis whose symptoms have previously cleared using a combined corticosteroid (Betnovate Cream) and moisturizer regimen
    E.2.2Secondary objectives of the trial
    Investigator’s Global Assessment (six-point scale) at visits 1 to 6 inclusive.
    Overall rating of response to study investigational product by Subject (five-point scale) at visits 4, 5 and 6.
    Change in the signs measured by SASSAD as determined by the Investigator’s SASSAD rating scale at weeks 4, 8 and 12 post-clearance as compared to baseline.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subjects with mild-to-moderate AD based on Hanifin and Rajka diagnosis criteria and Rajka and Langeland grading system (score of 3 to 7.5).
    2.An Investigator’s Global Assessment (IGA) score of 2 or 3.
    3.Subjects of either sex aged 2 to 65 years.
    4.Subjects who are willing and able to provide written informed consent. For subjects aged under 16 years of age, assent (where appropriate) and parental/guardian consent must be obtained.
    5.Subjects (and/or parent/guardian) who agree to utilise subject diaries for the purposes of recording their (their childs) responses to questions regarding the signs and symptoms of their AD.
    6.Subjects who are prepared to use the trial products and standardised washing regimen as instructed for the duration of the trial in place of their normal product and regimen.
    7.Sexually active females of childbearing potential participating in the study must use a medically acceptable form of contraception (which includes oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception). A female of childbearing potential is defined as one who is biologically capable of becoming pregnant.
    E.4Principal exclusion criteria
    1.Subjects with severe AD who require systemic or very-potent topical steroid treatment.
    2.Subjects with facial AD.
    3.Subjects with acutely infected AD, or areas where the lesions are crusted, weeping, or pustular.
    4.Female subjects who are pregnant or lactating.
    5.Subjects who are currently receiving or who have received during the 14 days before study entry, topical or systemic therapy likely to interfere with the study (e.g., antibiotic therapy, corticosteroids, anti-histamines, immunomodulators, anti-inflammatory agents).
    6.Subjects who have participated, who are currently participating or who plan to participate in any other research study involving an investigational product or device at any time during and after the 4 weeks before study entry.
    7.Subjects with any significant concurrent illness including psoriasis, rosacea, acne vulgaris, peri-oral dermatitis and primary skin lesions caused by infection with fungi or bacteria.
    8.Subjects with a history of skin disease, other than AD, or allergy, likely to interfere with the study.
    9.Subjects considered unable or unlikely to attend the necessary visits.
    10.Employees or an immediate family member (partner, offspring, parents, siblings, or sibling’s offspring) of an employee of Euroderm Research or Stiefel Laboratories.
    11.Subjects with past medical history of hepatic, renal, cardiac, pulmonary, digestive, hematological, neurological, locomotor, cancer or psychiatric disease, which, in the opinion of the Investigator would compromise the safety of the subject or affect the outcome of the study.
    12.Subjects with known sensitivity to the test product ingredients.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the difference in time to the next AD flare (days) between the treatment groups.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) Information not present in EudraCT
    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
    Medical Device W0153 and standard moisturiser (maintenance period)
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    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 Yes
    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
    Children 2-16 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 200
    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 Decision2007-07-16
    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 Status
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