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    Summary
    EudraCT Number:2016-002692-98
    Sponsor's Protocol Code Number:GH001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-13
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-002692-98
    A.3Full title of the trial
    An evaluation of the efficacy of HEXI-PREP by Clinell Wipes versus placebo and ChloraPrep, for use in pre-operative skin preparation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An evaluation of the efficacy of HEXI-PREP by Clinell Wipes versus placebo and ChloraPrep, for use in preoperative skin preparation
    A.3.2Name or abbreviated title of the trial where available
    HEXI-PREP by Clinell Wipes
    A.4.1Sponsor's protocol code numberGH001
    A.5.4Other Identifiers
    Name:2016-002692-98Number:EudraCT
    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 SponsorGAMA Healthcare
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGAMA Healthcare Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProTherax Ltd
    B.5.2Functional name of contact pointDavid Fairlamb
    B.5.3 Address:
    B.5.3.1Street Address3 Stepping Stones
    B.5.3.2Town/ cityEast Morton, Keighley
    B.5.3.3Post codeBD20 5UG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number 01274561815
    B.5.6E-maildavidfairlamb@protherax.com
    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 No
    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 nameHEXI-PREP by Clinell Wipes
    D.3.4Pharmaceutical form Cutaneous solution
    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 INNChlorhexidine Gluconate
    D.3.9.1CAS number 18472-51-0
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIsopropyl Alcohol
    D.3.9.1CAS number 67-63-0
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 RoleComparator
    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 ChloraPrep
    D.2.1.1.2Name of the Marketing Authorisation holderCareFusion UK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameChloraPrep
    D.3.4Pharmaceutical form Cutaneous solution
    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 INNChlorhexidine Gluconate
    D.3.9.1CAS number 18472-51-0
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIsopropyl Alcohol
    D.3.9.1CAS number 67-63-0
    D.3.9.4EV Substance CodeAS4
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 placeboCutaneous solution
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    For disinfection of the skin, immediately prior to invasive medical procedures
    E.1.1.1Medical condition in easily understood language
    For disinfection of the skin, immediately prior to invasive medical procedures
    E.1.1.2Therapeutic area Body processes [G] - Microbiological Phenomena [G06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10065586
    E.1.2Term Skin disinfection
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall trial objective is to evaluate the antimicrobial properties of HEXI-PREP by Clinell Wipes versus (1) Placebo, negative control (sterile saline 0.9%w/v) and (2) a positive control product, ChloraPrep (Chlorhexidine Gluconate 2.0%w/v / Isopropyl Alcohol 70%v/v) as per the methodology specified by the US Food & Drug Administration Tentative Final Monograph for Effectiveness Testing of a Patient Preoperative Skin Preparation.

    The primary objective of the study is to demonstrate superiority of HEXI-PREP by Clinell Wipe vs placebo (negative control) in reducing immediate bacterial load 1-10 minutes after administration to each respective test site.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study are to demonstrate superiority of HEXI-PREP by Clinell Wipe vs placebo (negative control) in terms of persistence of a reduction in bacterial load at time points from 30 minutes - 24 hours.
    Additionally, to assess the relative efficacy of HEXI-PREP by Clinell Wipes to ChloraPrep (positive control) in regard to a reduction in bacterial load at 1-10 minutes, and time periods 30 mins - 24 hours after administration to the test sites.
    A final secondary objective is to establish the safety profile (local tolerance) of the administered preparations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female participants 18-70 years, who have provided written informed consent to participate in the study.
    2. Treatment sites with a bacterial baseline count greater or equal to 5 log10/cm(2) at the groin, and greater or equal to 3 log10/cm(2) at the clavicle and median cubital fossa of the arm of Day -5 of the study.
    3. Participants, who in the opinion of the investigator, are in suitable health for inclusion in the study.
    E.4Principal exclusion criteria
    1. Participants who are exposed to topical antimicrobial agents, including medicated soaps, shampoos or lotions, who use biocide treated pools or hot-tubs, use tanning beds or sunbathing during the 14-day pre-test conditioning period or during the test period.
    2. Exposure of the test sites to strong detergents, solvents or other irritants during the 14-day pre-test conditioning period or during the test period.
    3. Use of systemic or topical antibiotic medications, steroid medications or any other product known to affect the normal microbial flora of the skin, up to 1 month prior to the screening period, during the 14-day pre-test conditioning period or during the test period.
    4. Known allergies to latex (rubber), alcohols, tape adhesives or to common antibacterial agents found in soaps, lotions or ointments, particularly chlorhexidine gluconate or chlorine.
    5. Female patients who are pregnant, become pregnant or are breast-feeding during the pre-test conditioning or during the test period.
    6. Active skin rashes or breaks in the skin at the test site
    7. Active skin diseases or inflammatory skin conditions including contact dermatitis within 10cm of the test site.
    8. Showering or bathing after Day -5 baseline sampling and unwilling to refrain from showering or bathing whilst at Surrey CRC (Day 0 to Day 1)
    9. Participation in another clinical trial within 90 days preceding randomisation
    10. Any other medical condition, which in the Investigator's opinion, should preclude participation.
    11. Unwillingness to fulfil the performance requirements of the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure will be based on a log10 reduction of the immediate baseline bacterial count at 1-10 minutes compared to placebo control.

    The co-primary analysis will test the hypothesis that HEXI-PREP by Clinell Wipe is superior to placebo at each of the three test sites within the ITT population at 1-10
    minutes after administration
    E.5.1.1Timepoint(s) of evaluation of this end point
    The co-primary analysis will test the hypothesis that HEXI-PREP by Clinell Wipe is superior to placebo at each of the three test sites within the ITT population at 1-10
    minutes after administration
    E.5.2Secondary end point(s)
    Secondary endpoint assessments will be based on persistence of a log10 reduction of the baseline bacterial counts at each of the three test sites over a period of up to 24 hours.
    Further secondary endpoints relate to local tolerance of the administered preparations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Persistence of a log10 reduction of the baseline bacterial counts will be conducted
    at 30 minutes and 6 hours (inguinal test sites) and 6 and 24 hours (clavicular and median cubital region of arm) after application to the test site compared to placebo and ChloraPrep active control
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Within participant
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 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 years0
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 240
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state240
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 240
    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)
    Ongoing therapy, if required, on completion of the clinical trial will be undertaken by referral to the participant's GP.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-06
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