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    Summary
    EudraCT Number:2021-006013-11
    Sponsor's Protocol Code Number:HOTPANTS
    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:2022-07-13
    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 number2021-006013-11
    A.3Full title of the trial
    Hyperbaric Oxygen Therapy for Pyoderma gangrenosum As a New Treatment Strategy
    Hyperbare Zuurstoftherapie voor pyoderma gangrenosum als nieuwe behandel mogelijkheid
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hyperbaric oxygen therapy for pyoderma gangrenosum
    Hyperbare zuurstoftherapie voor pyoderma gangrenosum
    A.4.1Sponsor's protocol code numberHOTPANTS
    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 SponsorErasmus MC, department of dermatology
    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 supportEADV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmusMC, department of dermatology
    B.5.2Functional name of contact pointCoördinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressDr.Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015CA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310107040110
    B.5.6E-maile.kop@erasmusmc.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 Oxygen
    D.2.1.1.2Name of the Marketing Authorisation holderSOL S.p.A. Via Borgazzi 27 20900 Monza Italy
    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 nameoxygen
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRespiratory use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.3Other descriptive nameOXYGEN
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeGas
    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
    Pyoderma gangrenosum
    Pyoderma gangrenosum
    E.1.1.1Medical condition in easily understood language
    Atypical chronic wounds
    Atypische chronische wonden
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the clinical efficacy of HBO treatment on top of standard regular wound care and anti-inflammatory treatment in patients with PG, with time to wound closure as the primary outcome. Controls will be treated with regular wound care and anti-inflammatory treatment.
    E.2.2Secondary objectives of the trial
    • To assess the effect of HBOT on:
    1. Changes in markers of inflammation, mRNA expression in micro-biopsies in wound edges.
    2. Alterations in mitochondrial O2 levels (non-invasive) with the use of off-label 5- ALA-plaster and CE approved COMET device
    3 The number of activated neutrophils in peripheral venous blood.
    • To assess the effect of HBOT on Pain reduction (NRS score).
    • To assess the effect of HBOT on Health Related-Quality of Life (WOUND-Q).
    • To assess the prevalence of recurrence of PG in patients treated with and without adjuvant HBOT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Confirmed diagnosis pyoderma gangrenosum by referring specialist (dermatologist, clinical immunologist or rheumatologist)
    • Unsatisfactory response of treatment after six weeks prednisone.
    • Fit for hyperbaric oxygen therapy as assessed by the hyperbaric physician.
    • Age ≥18 years at baseline
    • All genders
    • Able and willing to give written informed consent and to comply with the study requirements.
    - Bevestigde diagnose pyoderma gangrenosum door de verwijzende specialist (b.v. dermatoloog, klinisch immunoloog of rheumatoloog).
    - Onvoldoende respons op behandeling na 6 weken prednison
    - Fit om hyperbare zuurstoftherapie te ondergaan beoordeeld door de hyperbaar arts
    - Leeftijd 18 jaar en ouder op baseline.
    - Alle geslachten.
    - In staat en akkoord om informed consent te ondertekenen en voldoen aan de studie voorwaarden.
    E.4Principal exclusion criteria
    • Language barrier
    • Unable to give informed consent
    - Pregnancy
    - Taalbarriere
    - onvermogen om informed consent te geven
    - Zwangerschap
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the difference in wound healing time between the group with HBOT and the group without HBOT
    E.5.1.1Timepoint(s) of evaluation of this end point
    Wound healing time (time to full re-epithelialization) will be measured by the primary physician with a baseline of wound measurement and photography (3D validated measurement tool), after 3 weeks, 6 weeks (ending HBOT) and after 3 and 6 months (if the wounds are still present). Patients will be asked to perform weekly photographs (2D validated measurement tool) of the wounds if still present and sending these to the primary physician.
    E.5.2Secondary end point(s)
    - Difference in changes of inflammation markers, mRNA expression in micro-biopsies in wound edges in patients with pyoderma gangrenosum with and without HBOT
    - Difference in alterations in mitochondrial O2 levels (non-invasive) of pyoderma wounds versus patients without HBOT
    - Difference in the number of activated neutrophils in peripheral venous blood in patients with pyoderma gangrenosum with and without HBOT
    - Difference in Pain reduction (NRS score) in patients with pyoderma gangrenosum with and without HBOT
    - Difference in Improvement of Health Related-Quality of Life, with WOUND-Q in patients with pyoderma gangrenosum with and without HBOT
    - Difference in prevalence of recurrence of PG in patients treated with and without adjuvant HBOT.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Changes in inflammatory cytokines mRNA in pyoderma in patients with and without HBOT: start trial, week 3 and 6
    - Measurement effect of HBOT in mitochondria: alterations in mitochondrial O2 levels (non-invasive) of pyoderma wounds versus patients without HBOT: start trial, week 3 and 6
    - Neutrophil count in peripheral venous blood: start trial, week 3 and 6
    - Pain reduction (NRS score): standard measurement once a week.
    - Improvement of Health Related-Quality of Life, with WOUND-Q : start trial, week 6, 12, 26 and 52.
    - Recurrence of PG in patients treated with and without adjuvant HBOT: 12, 26 and 52 weeks
    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 Yes
    E.6.5Efficacy Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.7.1Other trial design description
    prospective cohort
    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
    standard wound care
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    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 years3
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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)
    Patients will be treated in accordance with general practice
    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 Decision2022-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-29
    P. End of Trial
    P.End of Trial StatusOngoing
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