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    Summary
    EudraCT Number:2016-003802-14
    Sponsor's Protocol Code Number:CRC-PSO-SKINPEN-A-27
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-10-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-003802-14
    A.3Full title of the trial
    Skin penetration of anti-inflammatory compounds in lesional compared to non-lesional skin of psoriasis patients
    Eindringen von entzündungshemmenden Wirkstoffen in erkrankter im Vergleich zu gesunder Haut von Patienten mit Schuppenflechte (Psoriasis)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Skin penetration of anti-inflammatory compounds in lesional compared to non-lesional skin of psoriasis patients
    Eindringen von entzündungshemmenden Wirkstoffen in erkrankter im Vergleich zu gesunder Haut von Patienten mit Schuppenflechte (Psoriasis)
    A.4.1Sponsor's protocol code numberCRC-PSO-SKINPEN-A-27
    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 SponsorCharité - Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportCharité - Universitätsmedizin Berlin
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité -Universitätsmedizin Berlin
    B.5.2Functional name of contact pointCharité -Universitätsmedizin Berlin
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number4930450518122
    B.5.5Fax number4930450518952
    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 Dexamethason 0,05% Creme LAW (CARINOPHARM GmbH Bahnhofstr. 1831008 Elze, registration number 3000820.00.01)
    D.2.1.1.2Name of the Marketing Authorisation holderCARINOPHARM GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDexamethason 0,05% Creme LAW
    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 INNDEXAMETHASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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 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 Protopic® 0,1% Salbe, LEO Pharma A/S Industriparken 55, 2750 Ballerup Danemark, registration numbers EU/1/02/201/003, EU/1/02/201/004, EU/1/02/201/006)
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameProtopic 0,1% Salbe
    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 INNtacrolimus monohydrate
    D.3.9.1CAS number 109581-93-3
    D.3.9.3Other descriptive nameTACROLIMUS MONOHYDRATE
    D.3.9.4EV Substance CodeSUB23141
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    Psoriasis vulgaris
    E.1.1.1Medical condition in easily understood language
    Psoriasis vulgaris
    Schuppenflechte
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10050576
    E.1.2Term Psoriasis vulgaris
    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
    The aim of this study is to compare skin barrier physiology, integrity and the penetration of topically applied anti-inflammatory drugs (dexamethasone, tacrolimus) in lesional (chronic psoriasis plaques) and non-lesional skin of young and aged psoriasis patients.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Male patients with the clinical diagnosis of psoriasis vul-garis
     age 25-35 years or ≥ 65 years
     Active psoriasis vulgaris lesions of the chronic plaque type, target lesion score ≥ 8, minimum area size in parallel with non-lesional skin (minimum area size 8 cm2) on the one upper thigh
     Skin type Fitzpatrick II-III
    E.4Principal exclusion criteria
     Skin lesions other than psoriasis-plaques in the investiga-tional sites
     Systemic anti-psoriatic therapy with therapies other than biologicals (e.g., retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the trial.
     Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to Visit 1 and during the trial:
    a. etanercept – within 4 weeks prior to Visit 1
    b. adalimumab, infliximab – within 2 months prior to Visit 1
    c. ustekinumab – within 4 months prior to Visit 1
    d. experimental products – within 4 weeks/5 halflives (whichever is longer) prior to Visit 1
     UVB therapy or excessive sun exposure therapy within 2 weeks prior to Visit 1 or during the trial.
     Any topical treatment on the scalp and body including corticosteroids (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 or during the trial.
     Predisposition to keloid formation or hypertrophic scars
     Known allergies or intolerance against any component of the study products or study material including disinfect-ants, local anesthetics, cyanoacrylate or other glue and tape components
     Known Diabetes mellitus
     Arterial hypertension with values of ≥ 140/90 mmHg at Screening visit
     Medication with beta-blockers
     Known thrombopenia, coagulation disorder or medication with anticoagulant
     Known allergies against any of the substances of the test medication
     Known allergies against local anesthetics
     Known allergy against ingredients of any glues
     Intake of acetylic acid or NSARs 10 days prior to first visit and during the study
     Atopic diseases (atopic dermatitis, allergic rhinitis, allergic asthma)
     History of malignant tumors or systemic immunologic diseases other than psoriasis
     Participation in another clinical trial in the last 4 weeks prior to this study
    E.5 End points
    E.5.1Primary end point(s)
    1. Tissue concentrations of topically applied anti-inflammatory drugs (dexamethasone 0,05% or tacrolimus 0,1%, respectively), in lesional (chronic psoriasis plaque) versus non-lesional thigh skin, assessed in eluates obtained by dermal microdialysis and in tissue extracts from skin punch biopsy assessed by mass spectrometry and x-ray microscopy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tissue concentration on eluates measured every 30 minutes during 6 hours (total collection time). Tissue concentration of dexamethasone 0,05% and tacrolimus 0,1% 6 hours after topical application will be determined in the skin biopsies using mass spectrometry. eluates, extracts from skin biopsies, non-invasive spectra and spectra from tissue sections.
    E.5.2Secondary end point(s)
    1. To assess the skin penetration of topically applied anti-inflammatory compounds (Dexamethason 0,05% Creme LAW®, Protopic® 0,1% Salbe) in lesional compared to non-lesional skin of psoriasis patients.
    2. To identify skin barrier parameters in lesional skin compared to non-lesional skin, which could serve as trigger signals for stimuli-responsive drug delivery systems.
    3. To compare the penetration and the differences between lesional and non-lesional skin in young patients to those in aged patients.
    4. To advance minimal-invasive and non-invasive analytical methods for skin penetration assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Skin penetration of dexamethasone 0.05% and tacrolimus 0, 1% will be measured using Raman Microscopy before (Visit 1, and Visit 2 hour 0) and after (Visit 2, hour 6) application of anti-inflammatory compounds.
    2. Skin barrier parameters (TEWL, SCH, pH, OCT, confocal microscopy) will be measured on visit 1 for lesional and non-lesional skin areas.
    3. Penetration profiles before (Visit 1, and Visit 2 hour 0) and after (Visit 2, hour 6) application of dexamethasone 0,05% or tacrolismus 0,1% will be compared between young and aged patients.
    4. The minimal invasive microdialysis will be performed on Visit 2 for a total period of 6 hours; the non-invasive procedure cyanoacrylate skin surface stripping will be perfomed at visit 1 to acess protease activity of lesional and non-lesional skin.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    The trial is an exploratory, experimental clinical study to compare skin barrier physiology, integrity and the penetration of topically applied anti-inflammatory drugs in lesional and non-lesional skin of young and aged psoriasis patients.
    The generated insights will directly be used to make decisions on the chemical architectures needed in clinical practice.
    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 No
    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 No
    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 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 years
    E.8.9.1In the Member State concerned months
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female No
    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 state24
    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)
    After study termination, the investigator will offer to the participant possible treatment options of his psoriasis. Upon subject's request, this treatment can also be initiated at the Charité Dermatology Department outpatient unit. In case of undesired effects/ adverse events which require treatment, the subject will be treated adeqately. At study end, all ongoing AEs/ local intolerances (i.e.itching, erythema, burning) will be followed up until they are resolved.
    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 Decision2016-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-07-10
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