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    Summary
    EudraCT Number:2019-002643-23
    Sponsor's Protocol Code Number:STH19966
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-01-06
    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 number2019-002643-23
    A.3Full title of the trial
    Validation of a novel composite of skin biomarkers as a primary outcome measure for evaluating the safety of treatments for atopic dermatitis: a randomized controlled trial (phase 2) comparing the effects of crisaborole 2% ointment to betamethasone valerate 0.1% cream on skin structure and function in participants with atopic dermatitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Skin bioMARkers for atopic eczema Therapy evaluation
    A.3.2Name or abbreviated title of the trial where available
    Skin bioMARkers for atopic eczema Therapy evaluation
    A.4.1Sponsor's protocol code numberSTH19966
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04194814
    A.5.4Other Identifiers
    Name:REC CommitteeNumber:20/EM/0006
    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 SponsorSheffield Teaching Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSheffield Teaching Hospitals NHS Foundation Trust
    B.5.2Functional name of contact pointAimee Card
    B.5.3 Address:
    B.5.3.1Street AddressClinical Research & Innovation Office
    B.5.3.2Town/ cityRoyal Hallamshire Hospital, Glossop Road
    B.5.3.3Post codeS10 2JF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0)114 226 5945
    B.5.5Fax number +44 (0)114 226 5937
    B.5.6E-mailaimee.card@nhs.net
    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 Eucrisa
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameEucrisa
    D.3.2Product code Crisaborole PF-06930164
    D.3.4Pharmaceutical form Ointment
    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 INNCrisaborole
    D.3.9.1CAS number 906673-24-3
    D.3.9.2Current sponsor codePF-06930164
    D.3.9.3Other descriptive name5-(4-cyanophenoxy)-1,3-dihydro-1-hydroxy-2,1-benzoxaborole
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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.IMP: 2
    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 holderGlaxo Wellcome UK 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.3.1Product nameBetnovate Cream
    D.3.2Product code 10949/0014
    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 INNBetamethasone Valerate
    D.3.9.1CAS number 2152-44-5
    D.3.9.3Other descriptive nameBetamethasone 17-valerate
    D.3.9.4EV Substance CodeAS2
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    atopic eczema (synonym atopic dermatitis) and the adverse treatment side effect epidermal atrophy
    E.1.1.1Medical condition in easily understood language
    atopic eczema (synonym atopic dermatitis) is a chronic, relapsing, inflammatory disease of the skin.

    Epidermal atrophy is skin thinning
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003641
    E.1.2Term Atopic eczema
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10040799
    E.1.2Term Skin atrophy
    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
    This study is a part of a program of work to develop new biomarkers to evaluate the safety of treatments for atopic dermatitis. Further details on the wider program can be found in the protocol.

    AIM OF THIS STUDY:
    To directly compare the effects of crisaborole (2%) ointment to the potent topical corticosteroid (TCS) betamethasone valerate (0.1%) cream on the properties of the skin using an established model for quantifying the local adverse effects of TCS.

    By achieving this aim, we will provide the data needed to identify the most informative biomarkers of epidermal atrophy/local adverse effects of TCS treatment using multivariate analysis techniques and develop a preliminary panel for further validation in a subsequent study.

    PRIMARY OBJECTIVE:
    To determine whether twice daily treatment with crisaborole (2%) ointment, compared to betamethasone valerate (0.1%) cream, for up to 4 weeks is a cause of skin atrophy in patients with atopic dermatitis.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    The following secondary objectives relate to research question 3:
    • To investigate the kinetics of changes in epidermal thickness measured by structural OCT brought about by treatment with crisaborole (2%) ointment and betamethasone valerate (0.1%) cream
    • To determine the tolerability of crisaborole (2%) ointment, compared to betamethasone valerate (0.1%) cream
    • To determine the effect of crisaborole (2%) ointment, compared to betamethasone valerate (0.1%) cream, on skin barrier function
    • To determine the effect of crisaborole (2%) ointment, compared to betamethasone valerate (0.1%) cream, on skin dryness and the levels of natural moisturising factor in the skin

    Exploratory objectives:
    The following exploratory objectives relate to research questions 1 and 2:
    • To investigate whether OCT-derived biomarkers (other than the established structural OCT biomarker) enable the accurate quantification of tissue changes (vascular and matrix) associated with epidermal a
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult participants with AD defined according to the UK working party diagnostic criteria
    2. Male or female aged 18-65 years old at baseline (Visit 1)
    3. Participants understands the purpose, modalities and potential risk of the trial
    4. Participants able to read and understand English
    5. Participants willing to sign the informed consent
    E.4Principal exclusion criteria
    1. Participants undergoing active drug treatment for AD (excludes the use of emollients) at baseline (Visit 1) and subject to any applicable washout period as defined by in section 8.8 ‘Prior and Concomitant Medication’
    2. Participants with a known allergy/hypersensitivity to any of the excipients of the trial investigational medicinal products.
    3. Participants with acne, suntan, birth marks, multiple nevi, tattoos, blemishes or dense body hair that obstruct the test areas.
    4. Investigator assessment of eczema severity at the treatment (anatomical) sites is almost clear or greater (score ≥1) based on the Investigators static global assessment scale at screening and baseline.
    5. Participants with a condition that in the opinion of the investigator contradicts participation in the study.
    6. Pregnant female participants; breastfeeding female participants; and female participants of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
    7. Use of any topical product on the test areas within 7 days prior to Baseline/Day 1, including cosmetic moisturizers and sunscreen. Use of moisturizers and/or sunscreen is permitted during the study to manage dry skin and sun exposure in areas surrounding but not on or overlapping the test areas.
    8. Participants who have used a tanning bed within 28 days of baseline (visit 1).
    9. Participants who have used any medication that could interfere with the trial aim prior to the start of the study (baseline/visit 1) treatment, and subject to the applicable washout period, as define in section 8.8 ‘Prior and Concomitant Medication’.
    10. Participants currently participating in another interventional clinical trial.
    11. Participants is incapable of giving fully informed consent.
    12. Participants judged by the PI to be inappropriate for the trial.
    E.5 End points
    E.5.1Primary end point(s)
    The difference in the change in epidermal thickness (day 29 – day 1), measured by structural OCT, between the sites treated with crisaborole (2%) ointment and betamethasone valerate (0.1%) cream.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Structural OCT images of epidermal thickness taken on day 1 and day 29
    E.5.2Secondary end point(s)
    The difference in the change in epidermal thickness measured by structural OCT during and after 28 days treatment.

    The difference in the change in visual redness/erythema score during and after 28 days treatment.

    The difference in the change in objective redness assessed with the Mexameter during and after 28 days treatment.

    The difference in the change in Trans-Epidermal Water Loss (TEWL) during and after 28 days treatment.

    The difference in skin barrier integrity (TEWLts20) after 28 days treatment.

    The difference in the change in visual skin dryness during and after 28 days treatment.

    The difference in Natural Moisturising Factor (NMF, filaggrin breakdown products) levels at the end of treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Structural OCT images of epidermal thickness taken on day 1, day 15, day 29 and day 57.

    Visual redness/erythema score determined on day 1, day 15, day 29 and day 57

    Objective redness assessed with the Mexameter measured on day 1, day 15, day 29 and day 57

    TEWL measurements on day 1, day 15, day 29 and day 57.

    TEWL measurements after tape-stripping (TEWLts20) on day 29

    Visual skin dryness scored on day 1, day 15, day 29 and day 57

    NMF will be quantified from superficial stratum corneum samples collected on day 29 using HPLC.
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 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 the trial is defined as the point at which all lab analyses required for the study endpoints has been completed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 37
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 37
    F.4.2.2In the whole clinical trial 37
    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. Since the intervention will not be used therapeutically here, there is no immediate need to continue to provide the treatment. betamethasone valerate cream is already available to patients on prescription. The efficacy of Crisaborole ointment has already been established and UK licencing is being sought.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-01-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-23
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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