Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Tolerance of virucidal alcohol-based hand rubs - healthy volunteer trial

    Summary
    EudraCT number
    		 2010-018624-20
    Trial protocol
    		 DE  
    Global end of trial date
    17 Jan 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Oct 2019
    First version publication date
    04 Oct 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    OPM-CIC-G-H-0902
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical Center - University of Freiburg
    Sponsor organisation address
    Breisacherstr. 153, Freiburg, Germany, 79110
    Public contact
    Prof Dr Dettenkofer, Markus, Medical Center - University of Freiburg, +49 761 27082070, annette.keldermann@uniklinik-freiburg.de
    Scientific contact
    Prof Dr Dettenkofer, Markus, Medical Center - University of Freiburg, +49 761 27082070, annette.keldermann@uniklinik-freiburg.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Dec 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Aug 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Uncoated viruses such as adenovirus or norovirus are a challenge for infection control strategies since these pathogens are highly resistant to disinfectants. Hand hygiene is accepted to be an essential measure to prevent infections caused by adeno- or norovirus. In case of an adeno- or norovirus infection within the clinical setting it is strongly recommended to use a virucidal hand rub and to exchange conventional hand disinfectants by virucidal ones (German recommendation by the Robert Koch-Institute; www.rki.de). Disadvantage of virucidal hand rubs, however, might be limited skin-tolerability compared to conventional products. This in turn may impair hand hygiene compliance. The aim of this trial is to compare the tolerability of three different virucidal hand rubs and a reference conventional product. This is a cross-over trial with 4 periods.
    Protection of trial subjects
    The safety, tolerability and acceptance of hand hygiene preparations impacts on compliance. In Germany, hand rub is classified as a drug, approval of which includes evaluation for efficacy, safety and tolerability. Nonetheless, few systematic scientific trials are available on the safety and tolerability of hand rubs. In particular, comparative data are missing for different preparations and their composition. The results obtained in this work on the safety and tolerability of four different virucidal hand rubs should provide important information to optimize their safety and tolerability.
    Background therapy
    		 none
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jun 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    22
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects were recruited from students of the Medical Center, University of Freiburg, and nursing students of the Freiburg Academy of Medical Professions. Inclusion criteria were subject's written informed consent, age > 18 years; legal capacity; healthy in body and mind and not under medical treatment at the time of inclusion.

    Pre-assignment
    Screening details
    		 healthy volunteers

    Period 1
    Period 1 title
    Intervention 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 R - P1 - P3 - P2 / Period 1
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 1 received R in period 1.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Softa-Man® pure
    Investigational medicinal product code
    60998.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (=total application of 90 mL per day).

    Arm title
    		 P1 - P2 - R - P3 / Period 1
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 2 received P1 in period 1.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Softa-Man(R) acute
    Investigational medicinal product code
    61000.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (= total application of 90 mL per day).

    Arm title
    		 P2 - P3 - P1 - R / Period 1
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 3 received P2 in period 1.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sterillium(R) virugard
    Investigational medicinal product code
    13814.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (= total application of 90 mL per day).

    Arm title
    		 P3 - R - P2 - P1 / Period 1
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 4 received P3 in period 4.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Manorapid(R) Synergy
    Investigational medicinal product code
    57801.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (=total application of 90 mL per day).

    Number of subjects in period 1
    		R - P1 - P3 - P2 / Period 1 P1 - P2 - R - P3 / Period 1 P2 - P3 - P1 - R / Period 1 P3 - R - P2 - P1 / Period 1
    Started
    5
    6
    6
    5
    Completed
    5
    6
    6
    4
    Not completed
    0
    0
    0
    1
         Consent withdrawn by subject
    -
    -
    -
    1
    Period 2
    Period 2 title
    Intervention 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Blinding of products were done by the pharmacy using a working bench.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 R - P1 - P3 - P2 / Period 2
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 1 received P1 in period 2.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Softa-Man(R) acute
    Investigational medicinal product code
    61000.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (= total application of 90 mL per day).

    Arm title
    		 P1 - P2 - R - P3 / Period 2
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 2 received P2 in period 2.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sterillium(R) virugard
    Investigational medicinal product code
    13814.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (= total application of 90 mL per day).

    Arm title
    		 P2 - P3 - P1 - R / Period 2
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 3 received P3 in period 2.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Manorapid(R) Synergy
    Investigational medicinal product code
    57801.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (=total application of 90 mL per day).

    Arm title
    		 P3 - R - P2 - P1 / Period 2
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 4 received R in period 2.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Softa-Man® pure
    Investigational medicinal product code
    60998.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (=total application of 90 mL per day).

    Number of subjects in period 2
    		R - P1 - P3 - P2 / Period 2 P1 - P2 - R - P3 / Period 2 P2 - P3 - P1 - R / Period 2 P3 - R - P2 - P1 / Period 2
    Started
    5
    6
    6
    4
    Completed
    5
    5
    6
    4
    Not completed
    0
    1
    0
    1
         Consent withdrawn by subject
    -
    1
    -
    1
    Joined
    0
    0
    0
    1
         Restarting
    -
    -
    -
    1
    Period 3
    Period 3 title
    Intervention 3
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Blinding of products were done by the pharmacy using a working bench.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 R - P1 - P3 - P2 / Period 3
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 1 received P3 in period 3.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Manorapid(R) Synergy
    Investigational medicinal product code
    57801.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (=total application of 90 mL per day).

    Arm title
    		 P1 - P2 - R - P3 / Period 3
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 2 received R in period 3.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Softa-Man® pure
    Investigational medicinal product code
    60998.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (=total application of 90 mL per day).

    Arm title
    		 P2 - P3 - P1 - R / Period 3
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 3 received P1 in period 3.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Softa-Man(R) acute
    Investigational medicinal product code
    61000.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (= total application of 90 mL per day).

    Arm title
    		 P3 - R - P2 - P1 / Period 3
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 4 received P2 in period 3.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sterillium(R) virugard
    Investigational medicinal product code
    13814.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (= total application of 90 mL per day).

    Number of subjects in period 3
    		R - P1 - P3 - P2 / Period 3 P1 - P2 - R - P3 / Period 3 P2 - P3 - P1 - R / Period 3 P3 - R - P2 - P1 / Period 3
    Started
    5
    5
    6
    4
    Completed
    3
    5
    5
    4
    Not completed
    2
    1
    1
    1
         Consent withdrawn by subject
    2
    1
    1
    1
    Joined
    0
    1
    0
    1
         Restarted
    -
    1
    -
    -
         Restarting
    -
    -
    -
    1
    Period 4
    Period 4 title
    Intervention 4
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Blinding procedure took place within the pharmacy.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 R - P1 - P3 - P2 / Period 4
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 1 received P2 in period 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sterillium(R) virugard
    Investigational medicinal product code
    13814.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (= total application of 90 mL per day).

    Arm title
    		 P1 - P2 - R - P3 / Period 4
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 2 received P3 in period 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Manorapid(R) Synergy
    Investigational medicinal product code
    57801.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (=total application of 90 mL per day).

    Arm title
    		 P2 - P3 - P1 - R / Period 4
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 3 received R in period 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Softa-Man® pure
    Investigational medicinal product code
    60998.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (=total application of 90 mL per day).

    Arm title
    		 P3 - R - P2 - P1 / Period 4
    Arm description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 4 received P1 in period 4.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Softa-Man(R) acute
    Investigational medicinal product code
    61000.00.00
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Cutaneous use
    Dosage and administration details
    4 days with 30 hand disinfections each day; 3 mL per hand disinfection (= total application of 90 mL per day).

    Number of subjects in period 4
    		R - P1 - P3 - P2 / Period 4 P1 - P2 - R - P3 / Period 4 P2 - P3 - P1 - R / Period 4 P3 - R - P2 - P1 / Period 4
    Started
    3
    5
    5
    4
    Completed
    5
    5
    4
    5
    Not completed
    0
    1
    2
    0
         Consent withdrawn by subject
    -
    1
    2
    -
    Joined
    2
    1
    1
    1
         Restarted
    2
    1
    1
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    R - P1 - P3 - P2 / Period 1
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 1 received R in period 1.

    Reporting group title
    P1 - P2 - R - P3 / Period 1
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 2 received P1 in period 1.

    Reporting group title
    P2 - P3 - P1 - R / Period 1
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 3 received P2 in period 1.

    Reporting group title
    P3 - R - P2 - P1 / Period 1
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 4 received P3 in period 4.

    Reporting group values
    		 R - P1 - P3 - P2 / Period 1 P1 - P2 - R - P3 / Period 1 P2 - P3 - P1 - R / Period 1 P3 - R - P2 - P1 / Period 1 Total
    Number of subjects
    		 5 6 6 5 22
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 5 6 6 5 22
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 23 (23 to 24) 26.5 (23.5 to 31) 24.5 (23.25 to 25.75) 25 (22 to 26) -
    Gender categorical
    Units: Subjects
        Female
    		 3 5 3 4 15
        Male
    		 2 1 3 1 7
    Subject analysis sets

    Subject analysis set title
    Safety analysis
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All the analyses were performed in the safety population, including subjects who had started treatment in at least one period.

    Subject analysis sets values
    		 Safety analysis
    Number of subjects
    22
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    22
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    25 (23 to 26)
    Gender categorical
    Units: Subjects
        Female
    15
        Male
    7

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    R - P1 - P3 - P2 / Period 1
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 1 received R in period 1.

    Reporting group title
    P1 - P2 - R - P3 / Period 1
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 2 received P1 in period 1.

    Reporting group title
    P2 - P3 - P1 - R / Period 1
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 3 received P2 in period 1.

    Reporting group title
    P3 - R - P2 - P1 / Period 1
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 4 received P3 in period 4.
    Reporting group title
    R - P1 - P3 - P2 / Period 2
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 1 received P1 in period 2.

    Reporting group title
    P1 - P2 - R - P3 / Period 2
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 2 received P2 in period 2.

    Reporting group title
    P2 - P3 - P1 - R / Period 2
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 3 received P3 in period 2.

    Reporting group title
    P3 - R - P2 - P1 / Period 2
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 4 received R in period 2.
    Reporting group title
    R - P1 - P3 - P2 / Period 3
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 1 received P3 in period 3.

    Reporting group title
    P1 - P2 - R - P3 / Period 3
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 2 received R in period 3.

    Reporting group title
    P2 - P3 - P1 - R / Period 3
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 3 received P1 in period 3.

    Reporting group title
    P3 - R - P2 - P1 / Period 3
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 4 received P2 in period 3.
    Reporting group title
    R - P1 - P3 - P2 / Period 4
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 1 received P2 in period 4.

    Reporting group title
    P1 - P2 - R - P3 / Period 4
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 2 received P3 in period 4.

    Reporting group title
    P2 - P3 - P1 - R / Period 4
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 3 received R in period 4.

    Reporting group title
    P3 - R - P2 - P1 / Period 4
    Reporting group description
    		 Healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of four days each with a washout period. Arm 4 received P1 in period 4.

    Subject analysis set title
    Safety analysis
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All the analyses were performed in the safety population, including subjects who had started treatment in at least one period.

    Primary: Transepidermal water loss (TEWL)

    		 Close Top of page
    End point title
    		 Transepidermal water loss (TEWL)
    End point description
    The primary endpoint was skin barrier function measured by transepidermal water loss (TEWL) in g/hm2 at the end of the 4-day application period.
    End point type
    Primary
    End point timeframe
    Measured at the end of the 4-day application period
    End point values
    		 R - P1 - P3 - P2 / Period 1 P1 - P2 - R - P3 / Period 1 P2 - P3 - P1 - R / Period 1 P3 - R - P2 - P1 / Period 1 R - P1 - P3 - P2 / Period 2 P1 - P2 - R - P3 / Period 2 P2 - P3 - P1 - R / Period 2 P3 - R - P2 - P1 / Period 2 R - P1 - P3 - P2 / Period 4 P1 - P2 - R - P3 / Period 4 P2 - P3 - P1 - R / Period 4 P3 - R - P2 - P1 / Period 4 R - P1 - P3 - P2 / Period 3 P1 - P2 - R - P3 / Period 3 P2 - P3 - P1 - R / Period 3 P3 - R - P2 - P1 / Period 3
    Number of subjects analysed
    4
    5
    6
    4
    5
    5
    6
    4
    3
    5
    3
    4
    5
    5
    4
    5
    Units: g/hm2
        arithmetic mean (standard deviation)
    26.93 ( 5.07 )
    21.26 ( 4.92 )
    19.25 ( 6.17 )
    13.93 ( 3.39 )
    17.92 ( 2.63 )
    19.94 ( 9.41 )
    15.48 ( 3.08 )
    23.98 ( 6.39 )
    13.40 ( 2.72 )
    20.67 ( 1.33 )
    23.74 ( 8.20 )
    28.03 ( 12.99 )
    17.08 ( 5.09 )
    21.50 ( 6.95 )
    24.08 ( 3.26 )
    13.02 ( 2.11 )
    Statistical analysis title
    		 Analysis of TEWL in SAF, P1 vs R
    Statistical analysis description
    This is a cross-over trial with 4 periods in 22 patients. The analysis was performed in the safety population (SAF) including all patients who started treatment in at least one of the 4 intervention period.
    Comparison groups
    R - P1 - P3 - P2 / Period 1 v P1 - P2 - R - P3 / Period 1 v P2 - P3 - P1 - R / Period 1 v P3 - R - P2 - P1 / Period 1 v R - P1 - P3 - P2 / Period 2 v P1 - P2 - R - P3 / Period 2 v P2 - P3 - P1 - R / Period 2 v P3 - R - P2 - P1 / Period 2 v R - P1 - P3 - P2 / Period 4 v P1 - P2 - R - P3 / Period 4 v P2 - P3 - P1 - R / Period 4 v P3 - R - P2 - P1 / Period 4 v R - P1 - P3 - P2 / Period 3 v P1 - P2 - R - P3 / Period 3 v P2 - P3 - P1 - R / Period 3 v P3 - R - P2 - P1 / Period 3
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.42
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.33
         upper limit
    		 2.26
    Notes
    [1] - The effects of the different agents on TEWL were analyzed in linear models including 'agent’, 'period', 'randomized sequence' and baseline measurement as fixed effects, and 'subject within sequence' as random effect. Differences between mean results per agent were estimated with 95% confidence intervals. This is the analysis of P1 vs R.
    Statistical analysis title
    		 Analysis of TEWL in SAF, P2 vs R
    Statistical analysis description
    This is a cross-over trial with 4 periods in 22 patients. The analysis was performed in the safety population (SAF) including all patients who started treatment in at least one of the 4 intervention period.
    Comparison groups
    R - P1 - P3 - P2 / Period 1 v P1 - P2 - R - P3 / Period 1 v P2 - P3 - P1 - R / Period 1 v P3 - R - P2 - P1 / Period 1 v R - P1 - P3 - P2 / Period 2 v P1 - P2 - R - P3 / Period 2 v P2 - P3 - P1 - R / Period 2 v P3 - R - P2 - P1 / Period 2 v R - P1 - P3 - P2 / Period 4 v P1 - P2 - R - P3 / Period 4 v P2 - P3 - P1 - R / Period 4 v P3 - R - P2 - P1 / Period 4 v R - P1 - P3 - P2 / Period 3 v P1 - P2 - R - P3 / Period 3 v P2 - P3 - P1 - R / Period 3 v P3 - R - P2 - P1 / Period 3
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.45
         upper limit
    		 -3.96
    Notes
    [2] - The effects of the different agents on TEWL were analyzed in linear models including 'agent’, 'period', 'randomized sequence' and baseline measurement as fixed effects, and 'subject within sequence' as random effect. Differences between mean results per agent were estimated with 95% confidence intervals. This is the analysis of P2 vs R.
    Statistical analysis title
    		 Analysis of TEWL in SAF, P3 vs R
    Statistical analysis description
    This is a cross-over trial with 4 periods in 22 patients. The analysis was performed in the safety population (SAF) including all patients who started treatment in at least one of the 4 intervention period.
    Comparison groups
    P1 - P2 - R - P3 / Period 1 v P2 - P3 - P1 - R / Period 1 v R - P1 - P3 - P2 / Period 1 v P3 - R - P2 - P1 / Period 1 v R - P1 - P3 - P2 / Period 2 v P1 - P2 - R - P3 / Period 2 v P2 - P3 - P1 - R / Period 2 v P3 - R - P2 - P1 / Period 2 v R - P1 - P3 - P2 / Period 4 v P1 - P2 - R - P3 / Period 4 v P2 - P3 - P1 - R / Period 4 v P3 - R - P2 - P1 / Period 4 v R - P1 - P3 - P2 / Period 3 v P1 - P2 - R - P3 / Period 3 v P2 - P3 - P1 - R / Period 3 v P3 - R - P2 - P1 / Period 3
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.0002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -7.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.45
         upper limit
    		 -3.9
    Notes
    [3] - The effects of the different agents on TEWL were analyzed in linear models including 'agent’, 'period', 'randomized sequence' and baseline measurement as fixed effects, and 'subject within sequence' as random effect. Differences between mean results per agent were estimated with 95% confidence intervals. This is the analysis of P3 vs R.
    Statistical analysis title
    		 Analysis of TEWL in SAF, P1 vs P2
    Statistical analysis description
    This is a cross-over trial with 4 periods in 22 patients. The analysis was performed in the safety population (SAF) including all patients who started treatment in at least one of the 4 intervention period.
    Comparison groups
    R - P1 - P3 - P2 / Period 1 v P1 - P2 - R - P3 / Period 1 v P2 - P3 - P1 - R / Period 1 v P3 - R - P2 - P1 / Period 1 v R - P1 - P3 - P2 / Period 2 v P1 - P2 - R - P3 / Period 2 v P2 - P3 - P1 - R / Period 2 v P3 - R - P2 - P1 / Period 2 v R - P1 - P3 - P2 / Period 4 v P1 - P2 - R - P3 / Period 4 v P2 - P3 - P1 - R / Period 4 v P3 - R - P2 - P1 / Period 4 v R - P1 - P3 - P2 / Period 3 v P1 - P2 - R - P3 / Period 3 v P2 - P3 - P1 - R / Period 3 v P3 - R - P2 - P1 / Period 3
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.0013
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.54
         upper limit
    		 9.79
    Notes
    [4] - The effects of the different agents on TEWL were analyzed in linear models including 'agent’, 'period', 'randomized sequence' and baseline measurement as fixed effects, and 'subject within sequence' as random effect. Differences between mean results per agent were estimated with 95% confidence intervals. This is the analysis of P1 vs P2.
    Statistical analysis title
    		 Analysis of TEWL in SAF, P1 vs P3
    Statistical analysis description
    This is a cross-over trial with 4 periods in 22 patients. The analysis was performed in the safety population (SAF) including all patients who started treatment in at least one of the 4 intervention period.
    Comparison groups
    R - P1 - P3 - P2 / Period 1 v P1 - P2 - R - P3 / Period 1 v P2 - P3 - P1 - R / Period 1 v P3 - R - P2 - P1 / Period 1 v R - P1 - P3 - P2 / Period 2 v P1 - P2 - R - P3 / Period 2 v P2 - P3 - P1 - R / Period 2 v P3 - R - P2 - P1 / Period 2 v R - P1 - P3 - P2 / Period 4 v P1 - P2 - R - P3 / Period 4 v P2 - P3 - P1 - R / Period 4 v P3 - R - P2 - P1 / Period 4 v R - P1 - P3 - P2 / Period 3 v P1 - P2 - R - P3 / Period 3 v P2 - P3 - P1 - R / Period 3 v P3 - R - P2 - P1 / Period 3
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.38
         upper limit
    		 9.89
    Notes
    [5] - The effects of the different agents on TEWL were analyzed in linear models including 'agent’, 'period', 'randomized sequence' and baseline measurement as fixed effects, and 'subject within sequence' as random effect. Differences between mean results per agent were estimated with 95% confidence intervals. This is the analysis of P1 vs P3.
    Statistical analysis title
    		 Analysis of TEWL in SAF, P2 vs P3
    Statistical analysis description
    This is a cross-over trial with 4 periods in 22 patients. The analysis was performed in the safety population (SAF) including all patients who started treatment in at least one of the 4 intervention period.
    Comparison groups
    R - P1 - P3 - P2 / Period 1 v P1 - P2 - R - P3 / Period 1 v P2 - P3 - P1 - R / Period 1 v P3 - R - P2 - P1 / Period 1 v R - P1 - P3 - P2 / Period 2 v P1 - P2 - R - P3 / Period 2 v P2 - P3 - P1 - R / Period 2 v P3 - R - P2 - P1 / Period 2 v R - P1 - P3 - P2 / Period 4 v P1 - P2 - R - P3 / Period 4 v P2 - P3 - P1 - R / Period 4 v P3 - R - P2 - P1 / Period 4 v R - P1 - P3 - P2 / Period 3 v P1 - P2 - R - P3 / Period 3 v P2 - P3 - P1 - R / Period 3 v P3 - R - P2 - P1 / Period 3
    Number of subjects included in analysis
    73
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 = 0.99
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.69
         upper limit
    		 3.64
    Notes
    [6] - The effects of the different agents on TEWL were analyzed in linear models including 'agent’, 'period', 'randomized sequence' and baseline measurement as fixed effects, and 'subject within sequence' as random effect. Differences between mean results per agent were estimated with 95% confidence intervals. This is the analysis of P2 vs P3.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Each day during the intervention period the volunteer was questioned about adverse events.
    Adverse event reporting additional description
    The percentage of subjects experiencing at least one adverse event
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13
    Reporting groups
    Reporting group title
    P1 Group
    Reporting group description
    		 P1 = Investigational Product 1: Softa-Man® acute

    Reporting group title
    P2 Group
    Reporting group description
    		 P2 = Investigational Product 2: Sterillium® virugard

    Reporting group title
    P3 Group
    Reporting group description
    		 P3 = Investigational Product 3: Manorapid® Synergy

    Reporting group title
    R Reference
    Reporting group description
    		 R = Reference: Softa-Man® pure

    Serious adverse events
    		 P1 Group P2 Group P3 Group R Reference
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 P1 Group P2 Group P3 Group R Reference
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 21 (85.71%)
    5 / 20 (25.00%)
    16 / 18 (88.89%)
    10 / 18 (55.56%)
    Injury, poisoning and procedural complications
    Skin injury
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Application site pruritus
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Erythema
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin exfoliation
         subjects affected / exposed
    13 / 21 (61.90%)
    5 / 20 (25.00%)
    14 / 18 (77.78%)
    8 / 18 (44.44%)
         occurrences all number
    13
    5
    14
    8
    Skin reaction
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 20 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
         occurrences all number
    0
    0
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    none

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26448861
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 11:33:36 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA