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    Summary
    EudraCT Number:2018-004222-28
    Sponsor's Protocol Code Number:LIKLO1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-02
    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 ConcernedSweden - MPA
    A.2EudraCT number2018-004222-28
    A.3Full title of the trial
    Efficacy of topical treatment with clobetasol in symptomatic oral lichen
    planus. A multicenter placebo-controlled randomized clinical trial.
    Effekten av lokalbehandling med klobetasol vid symptomgivande oral
    lichen planus. En multicenter placebokontrollerad randomiserad klinisk
    studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to assess the efficacy of Clobetasol mouth rinses in patients
    with oral lichen planus.
    Klinisk studie för att bedöma effekten av Clobetasol munsköljningar hos
    patienter med oral lichen planus.
    A.4.1Sponsor's protocol code numberLIKLO1
    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 SponsorMalmö University
    B.1.3.4CountrySweden
    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 supportMalmö University
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMalmö University
    B.5.2Functional name of contact pointFredrik Gränse
    B.5.3 Address:
    B.5.3.1Street AddressCarl Gustavs väg 34
    B.5.3.2Town/ cityMalmö
    B.5.3.4CountrySweden
    B.5.4Telephone number+46406658432
    B.5.6E-mailfredrik.granse@mau.se
    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 Klobetasol APL Munhålegel 0,025%
    D.2.1.1.2Name of the Marketing Authorisation holderAPL
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameKlobetasol APL Munhålegel 0,025%
    D.3.2Product code A01AC
    D.3.4Pharmaceutical form Mouthwash
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    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 placeboOromucosal gel
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Oral lichen planus
    Oral lichen planus
    E.1.1.1Medical condition in easily understood language
    Oral lichen planus is a common chronic inflammatory disease of the oral
    mucosa. It can cause symptoms ranging from mild discomfort to severe
    pain with difficulty eating and speaking.
    Oral lichen planus är en vanlig kronisk inflammatorisk sjukdom i
    munslemhinnan. Det kan orsaka symtom som sträcker sig från lätt
    obehag till svår smärta med svårigheter att äta och tala.
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10030983
    E.1.2Term Oral lichen planus
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 investigate the treatment effect of mouthwash with clobetasol
    compared to placebo in symptomatic oral lichen planus.
    Att undersöka behandlingseffekten av munsköljning med klobetasol
    jämfört med placebo vid symptomgivande oral lichen planus.
    E.2.2Secondary objectives of the trial
    To investigate the presence of candida in lichen lesions.
    Att undersöka förekomst av candida i lichen lesioner.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Symptomatic Oral lichen planus.
    2. Age > 40 years
    1. Symptomgivande oral lichen planus.
    2. Ålder > 40 år.
    E.4Principal exclusion criteria
    1. Lichenoid contact reactions.
    2. Graft versus host disease.
    3. Plaque-associated lichenoid reaction.
    4. Intraoral diseases with blisters.
    5. Ongoing treatment with antibiotics.
    6. Ongoing treatment with cortisone or other immunomodulatory drug.
    7. Hypersensitivity to clobetasol propionate.
    8. Severe periodontitis, as defined by Papapanou et al 2018 (4):
    CAL > 5 mm, probing depth> 6 mm, furcation involvement 2 and 3.
    9. Poor oral hygiene (plaque index [according to Silness-Löe]> 2).
    10. Oral lichen planus not verified by biopsy.
    11. Hypersensitivity to nystatin.
    12. Not reached menopaus.
    13. Ongoing or previosly intraoral malignancy.
    14. Ongoing participation in another drug study.
    1. Lichenoida kontaktreaktioner.
    2. Graft versus host disease.
    3. Plack-associerad lichenoid reaktion.
    4. Intraorala blåsbildande sjukdomar.
    5. Pågående behandling med antibiotika.
    6. Pågående behandling med kortison eller annat immunomodullerande
    läkemedel.
    7. Överkänslighet mot klobetasolpropionat.
    8. Svår parodontit, definition enl Papapanou et al 2018:
    Klinisk stödjevävnadsförlust > 5 mm, fickdjup > 6 mm,
    furkationsinvolvering 2 och 3.
    9. Uttalat dålig munhygien (plackindex [enl Silness-Löe] > 2).
    10. Ej biopsiverifierad oral lichen planus.
    11. Överkänslighet mot nystatin.
    12. Ej uppnådd menopaus.
    13. Pågående eller tidigare intraoral malignitet.
    14. Pågående deltagande i annan läkemedelsstudie.
    E.5 End points
    E.5.1Primary end point(s)
    Change in lesion Activity score
    Förändring i lesionens Activity score
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of 4 weeks treatment.
    Efter 4 veckors behandling
    E.5.2Secondary end point(s)
    Change in OHIP-14
    Change in Pain score
    Change in Burning sensation score
    Förändring i OHIP-14
    Förändring i Pain score
    Förändring i Burning sensation score
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of 4 weeks treatment.
    Efter 4 veckors behandling
    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 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 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 trial3
    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 concerned2
    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
    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 days28
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state90
    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)
    None
    Ingen
    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 Decision2020-02-10
    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 StatusOngoing
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