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    Summary
    EudraCT Number:2018-004338-13
    Sponsor's Protocol Code Number:TOPIC
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-28
    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 number2018-004338-13
    A.3Full title of the trial
    Short term clinical efficacy of topical treatment with clindamycin-benzoyl peroxide gel compared with clindamycin lotion in mild to moderate Hidradenitis Suppurativa
    Effectiviteit van lokale behandeling met clindamycine 1%/benzoyl peroxide 5% gel vergeleken met clindamycine 1% lotion.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical effect of topical treatment with clindamycin-benzoyl peroxide gel compared with clindamycin lotion in mild to moderate Hidradenitis Suppurativa
    Effectiviteit van lokale behandeling met clindamycine 1%/benzoyl peroxide 5% gel vergeleken met clindamycine 1% lotion.
    A.3.2Name or abbreviated title of the trial where available
    TOPIC
    A.4.1Sponsor's protocol code numberTOPIC
    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 SponsorDepartment of Dermatology, Erasmus University Medical Center
    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 supportErasmus University Medical Center, Department of Dermatology
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus University Medical Center, Department of Dermatology
    B.5.2Functional name of contact pointE.P. Prens
    B.5.3 Address:
    B.5.3.1Street Addressdr. Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 GD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310107040110
    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 Duac gel
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    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 nameDUAC
    D.3.2Product code RVG 31531
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hidradenitis Suppurativa
    Hidradenitis Suppurativa
    E.1.1.1Medical condition in easily understood language
    Hidradenitis Suppurativa
    Hidradenitis Suppurativa
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020041
    E.1.2Term Hidradenitis suppurativa
    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
    To assess the frequency of flares (active lesions) over the course of 12 weeks of treatment.
    Bepalen van de frequentie van actieve leasies tijdens 12 weken behandeling.
    E.2.2Secondary objectives of the trial
    - To assess the clinical efficacy after 12 weeks of treatment.
    - To assess the skin-related pain after 12 weeks of treatment.
    - To assess the pruritus after 12 weeks of treatment.
    - To assess treatment satisfaction after 12 of treatment.
    - To assess the sustained efficacy and treatment satisfaction after 4 weeks of follow-up after end of treatment.
    - To evaluate the effect of both treatments on the diversity of the microbiome after 12 weeks of treatment and 4 weeks of follow-up after end of treatment.
    - To evaluate the change in resistance pattern after 12 weeks of treatment and 4 weeks of follow-up after end of treatment.
    - To assess the short-term safety and tolerability of both treatments.
    - Bepalen van klinische effectiviteit na 12 weken behandeling.
    - Bepalen van huid-gerelateerde pijn na 12 weken behandeling.
    - Bepalen van jeuk na 12 weken behandeling.
    - Bepalen tevredenheid van de behandeling na 12 weken behandeling.
    - Bepalen van het voortduren van klinische effectiviteit na 4 weken follow-up na eind van de behandeling.
    - Bepalen van de diversiteit van het microbioom na 12 weken behandeling en na 4 weken na follow-up na eind van de behandeling.
    - Bepalen van het resistentiepatroon na 12 weken behandeling en na 4 weken na follow-up na eind van de behandeling.
    - Bepalen van veiligheid en verdraagbaarheid van beide behandelingen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years.
    2. Mild to moderate HS defined as a HS-PGA of 2 or 3 with at least 2 lesions in each eligible anatomical area.
    3. A diagnosis of HS for more than six months prior to baseline.
    4. Able and willing to give written informed consent and to comply with the study requirements
    1. Leeftijd ≥18 jaar.
    2. Mild tot matige HS gebaseerd op een HS-PGA van 2 of 3 met minimaal 2 leasies in elke in aanmerking komende anatomische lichaamsregio.
    3. Diagnose van HS minimal 6 maanden voor baseline.
    4. Beireid om geschreven informed consent te geven en zich te houden aan de regels die gelden binnen de studie.
    E.4Principal exclusion criteria
    1. Contraindication for treatment with either clindamycin lotion 1% or clindamycin 1%/benzoyl peroxide 5% gel.
    2. Superinfection of HS lesions.
    3. Current or recurrent clinically significant skin condition in the HS treatment area other than HS.
    4. Presence of other uncontrolled clinically significant major disease.
    5. Pregnant and lactating women.
    6. The use of systemic antibiotics 14 days prior to inclusion.
    7. The use of topical antibiotics or Resorcinol cream in the eligible areas 14 days prior to inclusion.
    1. Contraindicatie voor clindamycine lotion 1% ofclindamycine 1%/benzoylperoxide 5% gel.
    2. Superinfectie van HS leasies.
    3. Huidige, of terugkerende klinisch significante huid ziekte in de te behandelen regio, buiten HS.
    4. Aanwezigheid van ongecontroleerde klinisch significante ziekte.
    5. Zwangere vrouwen en vrouwen die borstvoeding geven.
    6. Gebruik van systemische antibiotica 14 dagen voor inclusie.
    7. Gebruik van topicale antibiotica en Resorcinol cream in de in aanmerking komende anatomische regio's 14 dagen voor inclusie.
    E.5 End points
    E.5.1Primary end point(s)
    The frequency of flares (active lesions)
    Bepalen van de frequentie van actieve leasies
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over the course of 12 weeks of treatment.
    Tijdens 12 weken behandeling.
    E.5.2Secondary end point(s)
    1. Clinical efficacy
    2. Skin-related pain
    3. Pruritus
    4. Treatment satisfaction
    5. Sustained efficacy
    6. Diversity of the microbiome
    7. Resistance pattern
    8. The short-term safety and tolerability of both treatments
    - Klinische effectiviteit
    - Huid-gerelateerde pijn
    - Jeuk
    - Tevredenheid met de behandeling
    - Voortduren van klinische effectiviteit
    - Diversiteit van het microbioom
    - Resistentiepatroon
    - Veiligheid en verdraagbaarheid van beide behandelingen
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints 1,2,3, 4, 6, 7, and 8 will be measured after 12 weeks of treatment. Endpoint 4, 5, 6, and 7 will also be measured after 4 weeks of follow-up after end of treatment.
    Secondaire eindpunten 1,2,3, 4, 6, 7, and 8 worden gemeten na 12 weken behandeling. Endpunten 4, 5, 6, and 7 worden ook gemeten na 4 follow-up na behandeling.
    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 Yes
    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 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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Beoordelaar is geblindeerd, en binnen 1 patient
    Assesor blinded and intra-patient
    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.8.5The 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 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: 30
    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 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 state30
    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
    Geen
    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 Decision2019-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-11
    P. End of Trial
    P.End of Trial StatusOngoing
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