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    The EU Clinical Trials Register currently displays   38596   clinical trials with a EudraCT protocol, of which   6341   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-000877-30
    Sponsor's Protocol Code Number:SK0608
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-27
    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 number2006-000877-30
    A.3Full title of the trial
    A 6 week, multi centre study to evaluate the efficacy and safety of E45 complete emollient therapy and E45 itch relief cream in the treatment of mild to moderate atopic eczema compared to a patients normal emollient regime defined as the frequent use of emollient/s (not containing lauromacrogols) listed in the BNF.
    A.3.2Name or abbreviated title of the trial where available
    Harbour Study
    A.4.1Sponsor's protocol code numberSK0608
    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 SponsorReckitt Benckiser Healthcare International
    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 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 E45 Cream
    D.2.1.1.2Name of the Marketing Authorisation holderCrookes Healthcare Limited
    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 IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnhydrous Lanolin
    D.3.9.1CAS number 8006-54-0
    D.3.9.3Other descriptive nameWool Fat
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.3Concentration number1.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNWhite Soft Paraffin
    D.3.9.1CAS number 8009-03-8
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.3Concentration number14.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLight Liquid Paraffin
    D.3.9.1CAS number 8012-95-1
    D.3.9.3Other descriptive nameMineral Oil
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.3Concentration number12.6
    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.IMP: 2
    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 E45 Itch Relief Cream
    D.2.1.1.2Name of the Marketing Authorisation holderCrookes Healthcare Limited
    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 IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLauromacrogol 400
    D.3.9.3Other descriptive nameLauromacrogols / Polidocanol
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.3Concentration number3.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUrea
    D.3.9.1CAS number 57-13-6
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.3Concentration number5.0
    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 Eczema
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of E45 complete emollient therapy against an unchanged emollient regime along with the role of E45 anti itch cream in controlling itch. This will be evaluated through validated quality of life questionnaires, investigators global assessment and diary cards.
    E.2.2Secondary objectives of the trial
    The secondary objective is to compare the tolerability of an E45 regime and the itch cream against an unchanged emollient regime. This will be evaluated through the collection of adverse events and a patient satisfaction questionnaire.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Only patients to whom all of the following conditions apply will be included:
    1. Age: 2-16 years of age
    2. Sex: male and female
    3. Primary diagnosis: A diagnosis of atopic eczema as defined by the UK working party criteria and confirmed by a general practitioner
    4. Patients who are using one of the top ten emollients (excluding lauromacrogols) listed in the BNF (see Appendix VI).
    5. Status: patients at an enrolled site whose diagnosis of atopic eczema is defined as mild to moderate by the Rajka and Langeland criteria (1989) (a score of 3 - 7.5) and for whom their IGA does not >/ = 3
    6. Patients who have a body surface area of at least 2% affected by atopic eczema.
    7. Patients for whom the adult with parental responsibility has given written informed consent and for who have themselves given concurrent assent.
    E.4Principal exclusion criteria
    Patients to whom any of the following conditions apply must be excluded:
    1. Patients who are pregnant or breast feeding.
    2. Patients who have used topical treatments other than emollients for the treatment of their atopic dermatitis in the last 3 days prior to consent (this includes but is not limited to all topical steroid preparations, Protopic, Elidel, antibioitics)
    3. Patients who have used any light or systemic treatments (including anti histamines) for the treatment of their atopic dermatitis in the past 28 days prior to consent.
    4. Patients who are using or have used in the past 28 days prior to consent systemic corticosteroids for the treatment of any disease.
    5. Patients who currently have or are suspected of previously having any disease (dermatological or other) that may interfere with the study protocol.
    6. Those previously randomised into the study.
    7. Those who have participated in a clinical trial in the previous 12 weeks prior to consent.
    8. Patients who are using, intend to use or have used in the preceding 4 weeks prior to consent any alternative, homeopathic treatments.
    9. Any previous history of allergy or known intolerance to any of the drugs or formulation constituents
    10. Those unable in the opinion of the Investigator to comply fully with the study requirements.
    E.5 End points
    E.5.1Primary end point(s)
    The study will look at two primary efficacy endpoints.
    The first, to assess the overall efficacy of the E45 emollient therapy regime, is the change in validated quality of life score (children’s dermatology life quality index (CDLQI)) from baseline to week 6, comparing treatment groups A and C.
    The second, to assess the efficacy of the E45 itch relief cream, is the cumulative change in the itch-severity visual analogue scale over the course of the study, comparing treatment groups A and B.
    Secondary efficacy endpoints include:
    · changes in the quality of life score at weeks 1 and 3
    · changes in the itch visual analogue scale by week
    · changes in the dermatitis family impact questionnaire
    · changes in the IGA
    · changes in the itch 4-point grading scale
    · changes in the subjective global assessment (SGA)
    · the number of eczema flares recorded (defined as an IGA > or = 3)

    Safety endpoints will include the incidence of all adverse events, serious adverse events, and treatment-related adverse events.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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
    Emollient/s (not containing lauromacrogols) listed in the BNF
    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 concerned15
    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
    The end of the study is defined as the last visit of the last subject undergoing the study.
    Reckitt Benckiser will notify the regulatory authority and ethics committee within 90 days of the end of the study (within 15 days if the study is ended prematurely).
    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 days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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
    Children and adolescents 2-16
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    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 Decision2006-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-02-16
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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