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    Summary
    EudraCT Number:2020-002201-25
    Sponsor's Protocol Code Number:CHDR2007
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-07-17
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-002201-25
    A.3Full title of the trial
    A two-part (observational and intervention) study to explore disease characteristics of vulvar (pre)malignancies compared to healthy volunteers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Researching the characteristics of cancerous tissue of the reproduction organ of females.
    A.3.2Name or abbreviated title of the trial where available
    Deep phenotyping of vulvar (pre)malignant disease.
    A.4.1Sponsor's protocol code numberCHDR2007
    A.5.4Other Identifiers
    Name:ToetsingOnline number Number:NL73964.058.20
    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 SponsorCentre for Human Drug Research
    B.1.3.4CountryNetherlands
    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 supportCentre for Human Drug Reserach
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre for Human Drug Research
    B.5.2Functional name of contact pointNA
    B.5.3 Address:
    B.5.3.1Street AddressZernikedreef 08
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CL
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715246400
    B.5.5Fax number+31715246499
    B.5.6E-mailclintrials@chdr.nl
    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 Clobetasol propionate
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameClobetasol
    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 INNCLOBETASOL
    D.3.9.1CAS number 25122-41-2
    D.3.9.4EV Substance CodeSUB06678MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    lichen sclerosus, vulvar (pre)malignancies
    E.1.1.1Medical condition in easily understood language
    cancerous tissue of the female reproductive organ
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    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 evaluate disease related characteristics in patients with different vulvar conditions compared to healthy volunteers;
    To evaluate the variability of the selected biomarkers between subjects, and within subjects over time.
    E.2.2Secondary objectives of the trial
    To evaluate the feasibility, suitability and potential use of the skin microbiome as biomarker for early phase clinical drug development in patients with different vulvar conditions and to compare with healthy individuals.

    To design a machine learning model for diagnosis of vulvar (pre)malignant disease by combining individual biomarker assessments.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Non-pregnant female subjects, 25-95 years of age (inclusive); in general, stable good health as per judgment of the investigator based upon the results of a medical history, physical examination (BMI ≤ 30) and vital signs.
    2. If female of childbearing potential, have a negative urine pregnancy test at Day 0.
    3. Willing to give written informed consent and willing and able to comply with the study protocol.
    4. Ability to communicate well with the investigator in the Dutch or English language.
    5. Subject is willing to undergo vulvar biopsies.
    6. Subject is willing to refrain from washing (including bathing, swimming, showering and excessive sweating) the vulva counting from midnight of every study visit day.
    7. Subject is willing to refrain from application of products (e.g. ointments, crème or wash) on the vulva 24 hours prior to every study visit day.
    8. Subject is willing to refrain from sexual intercourse less than 24 hours prior to every study visit.
    9. Subject is willing to refrain from shaving, waxing or other hair removing treatments in the perineal area in the 24 hours prior to every study visit.
    10. Willing to refrain from any active treatment for vulvar HSIL and LS as from 14 days prior to Day 0.

    Eligible HSIL patients must meet all of the following inclusion criteria at screening:
    11. At least one sharply marginated lesion (plaque) that can be accurately measured (using RECIST criteria), in at least one dimension with a smallest diameter of ≥15 mm, with confirmed HSIL diagnosis by histologic confirmation. This histologic diagnosis does not necessarily have to be performed close to inclusion.

    Eligible LS patients must meet all of the following inclusion criteria at screening:
    12. Clinically and/or histologically diagnosed with LS and under topical treatment with topical corticosteroids or willing to start topical steroid treatment during study participation.

    Eligible VSCC patients must meet all of the following inclusion criteria at screening:
    13. Histologically confirmed primary or local recurrent VSCC.
    E.4Principal exclusion criteria
    1. Significant, uncontrolled or unstable disease in any organ system as per judgment of the investigator (regardless of association with the immunosuppressing disorder/therapy), including but not limited to: psychiatric, neurologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrine, hematologic or respiratory disease.
    2. History of immunological abnormality (e.g., immune suppression) that may interfere with study objectives, in the opinion of the investigator.
    3. Known infection requiring (topical or oral) antibiotic therapy within 28 days prior to Day 0;
    4. The use of any oral/systemic medication (e.g. immunomodulatory, immunosuppressive, acetylsalicylic acid) within 28 days prior to Day 0, if the investigator judges that it may interfere with the study objectives. The use of paracetamol (up to 4 g/day) is allowed;
    5. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
    6. Self-reported: (a) immunocompromised state, (b) sexually transmitted disease, (c) AIDS and/or (d) hepatitis.
    7. Have any current and / or recurrent clinically significant or subject reported skin condition in the vulvar area other than the vulvar disease wherefore subject is included in the study.

    Eligible vulvar patients must meet none of the following exclusion criteria at screening:
    8. Have any current relevant (inflammatory) skin infections in the treatment area other than the observational disease (vulvar LS, vulvar HSIL of VSCC), inclusively, but not limited to atopic dermatitis, herpes, candidiasis or psoriasis.
    9. Have used or received any topical vulvar HSIL treatment, laser therapy or surgery in the anogenital area within 28 days prior to Day 0
    10. Have used or received any topical corticosteroids or other topical immune suppressive treatment for LS within 14 days prior to Day 0
    11. Have used or received chemo-or radiotherapy or surgery in the anogenital area within 3 months prior to enrolment.
    E.5 End points
    E.5.1Primary end point(s)
    • Comparable biomarker measurements (as described below under endpoints) over time and within each subgroup for the observational part of the study
    • Difference in non-invasive and/or invasive biomarker measurements between different subgroups (that ultimately could lead to improved disease classification)
    • LS subgroup: change in any of the invasive and/or non-invasive biomarkers after 14 days of treatment with a topical steroid compared to measurements of untreated/non-lesional skin
    • Punch biopsies: histology (e.g. H&E), IHC (e.g. p16 and p53), mRNA extraction
    • Vulvar pH*
    • Hormonal status (FSH, LS, estrogen)
    • DermaToolbox:
    - 2D photography* (photo documentation)
    - 3D photography* (lesion dimensions)\ - Dermoscopy* (erythema + roughness scores)
    - Optical Coherence Tomography* (skin morphology, skin layer thickness, blood perfusion)
    - Confocal Microscopy* (skin morphology)
    - Ultrasonography* (skin morphology, skin layer thickness, tumour penetration up to 4cm)
    - Trans Epidermal Water Loss* (skin barrier function)
    •Clinical scores (e.g. Gunther, RECIST, PROVOKE)
    • Patient reported outcomes* (this may include, but is not limited to: NRS pruritus, NRS burning sensation, NRS pain, sleeplessness QoL, patient satisfaction scores of imaging tools)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0 - EOS
    E.5.2Secondary end point(s)
    • Anal microbiome* (16shRNA)
    • Vulvar and vaginal swabs* for microbiome and HPV typing

    Comparison using a Voting Classifier of the following models in the classification prediction:
    • Logistic Regression
    • Support Vector Machine
    • Linear Discriminant Analysis
    • Random Forest Classifier
    • Gradient Boost Classifier
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0 - EOS
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 No
    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
    Healthy volunteers which require no treatment
    E.8.2.4Number of treatment arms in the trial1
    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 years1
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    Return for care to General Pracitioner oo Medical Specialist.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation LUMC
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-10-15
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