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    Clinical Trial Results:
    A randomised, placebo-controlled trial to investigate the effectiveness of an antimicrobial product in the elimination of Staphylococcus aureus colonisation from the anterior nares of adult subjects with atopic eczema. A proof of concept study (the NASSAELIM pilot).

    Summary
    EudraCT number
    		 2011-004183-29
    Trial protocol
    		 GB  
    Global end of trial date
    21 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 May 2016
    First version publication date
    06 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DERC-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dermal Laboratories Limited
    Sponsor organisation address
    Tatmore Place, Gosmore, Hitchin, United Kingdom, SG4 7QR
    Public contact
    Krystyna Sykes, Dermal Laboratories, 01462 458866, clinical@dermal.co.uk
    Scientific contact
    Krystyna Sykes, Dermal Laboratories, 01462 458866, clinical@dermal.co.uk
    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
    11 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Apr 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The principal objective was to determine whether the test cream is more effective than placebo (blank product) at removing Staphylococcus aureus bacteria from the nostrils of individuals with atopic eczema, when instilled into the nostrils 3 times daily for 7 days. This was determined by microbiological screening of swabs taken from the nostrils before and after treatment.
    Protection of trial subjects
    Nasal Staphylococcus aureus decolonisation was not, at the time of the study, undertaken as part of standard care in atopic eczema, and so treatment with a test IMP of unknown effectiveness for this particular purpose, or indeed with a placebo IMP, raised no added risks as such to human subjects. Also the study design was such that admitted subjects’ participation did not affect their standard of care or their ongoing treatment for atopic eczema or any other ongoing medical condition. Microbiological swabbing, although frequent, was minimally invasive and, at worse, an inconvenience.
    Background therapy
    		 The subjects were allowed to carry on applying their usual treatments to manage their eczema or any other ongoing medical condition with the exception of oral corticosteroid, oral immunosuppressant or oral antibacterial treatment. However, the subjects were asked not to use any other topically applied nasal treatments apart from the test products.
    Evidence for comparator
    		 The use of the Placebo comparator in this study was chosen because this is the gold standard when assessing effectiveness and because this did not present any significant ethical issues; given that Nasal Staphylococcus Aureus decolonisation was not, at the time of the study, undertaken as part of standard care in atopic eczema.
    Actual start date of recruitment
    27 Oct 2014
    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
    United Kingdom: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    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)
    6
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment rate was exceptionally slow (only 18 were screened and 6 randomised in 6 months compared to the expectation in the study protocol of screening 60-100 potential subjects in this period). The study was therefore terminated.

    Pre-assignment
    Screening details
    		 Eligible subjects were adults aged >16 years old, diagnosed with Atopic Eczema and screened positive for the presence of Staphylococcus aureus (SA) in the nostrils. 18 subjects attended screening, of which 1 subject did not meet initial eligibility criteria, 1 subject dropped out and 10 subjects tested negative for SA and so were not randomised.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    The test product and placebo were presented in identical containers and labelled (in accordance with the randomisation list) by an independent Sponsor department; blinded from the clinical team. Investigators were issued code-break envelopes for use in case of emergency. The primary endpoint was Staphylococcus Aureus elimination determined microbiologically. Subjects were asked to refrain from discussing their particular study treatment with other subjects and with the investigator/CRO staff.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Test product (DERC)
    Arm type
    		 Experimental

    Investigational medicinal product name
    DERC
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Intranasal use
    Dosage and administration details
    Subjects were asked to gently apply a match head size of the product into each nostril 3 times daily for a treatment period of 7 days.

    Arm title
    		 Placebo
    Arm description
    		 Placebo comparator
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PL1
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Intranasal use
    Dosage and administration details
    Subjects were asked to gently apply a match head size of the product into each nostril 3 times daily for a treatment period of 7 days.

    Number of subjects in period 1
    		Active Placebo
    Started
    2
    4
    Completed
    2
    3
    Not completed
    0
    1
         Withdrawn due to early termination
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All randomised subjects

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 6 6
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 6 6
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 3 3
        Male
    		 3 3
    Ethnic group
    Units: Subjects
        Caucasian
    		 6 6
    Solar skin type
    Units: Subjects
        White (always burns, never tans)
    		 0 0
        White (usually burns, tans with difficulty)
    		 2 2
        Cream (sometimes mild burn, gradually tans)
    		 4 4
        Brown (rarely burns, tans with ease)
    		 0 0
        Dark brown (very rarely burns, tans very easily)
    		 0 0
        Black (never burns, tans very easily)
    		 0 0
    Baseline swab result: Staphylococcus Aureus
    Units: Subjects
        Positive (colony count >1000 CFU)
    		 6 6
        Negative
    		 0 0
    Baseline swab result: Presence of MRSA
    Units: Subjects
        Positive
    		 0 0
        Negative
    		 6 6
    Objective SCORAD classification of Atopic Eczema
    Units: Subjects
        Mild Atopic Eczema
    		 5 5
        Moderate Atopic Eczema
    		 1 1
        Severe Atopic Eczema
    		 0 0
    Baseline Objective SCORAD
    Units: Objective SCORAD
        median (full range (min-max))
    		 9 (3 to 18) -

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Test product (DERC)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo comparator

    Primary: Primary

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    End point title
    		 Primary [1]
    End point description
    The percentage of subjects with Staphylococcus Aureus (SA) eradicated from the anterior nares at the end of the treatment period (day 8 swabbing), for each treatment group.
    End point type
    Primary
    End point timeframe
    End of treatment (day 8 microbiological swabbing)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis for this end point as study terminated owing to unacceptably slow recruitment.
    End point values
    		 Active Placebo
    Number of subjects analysed
    2
    3 [2]
    Units: % Subjects with SA eradicated
    0
    0
    Notes
    [2] - One subject withdrawn due to early termination
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 50 days depending on subjects' microbiological screening results for Staphylococcus Aureus nasal colonisation (this includes 2 weeks late onset)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    All randomised patients
    Reporting group description
    		 -

    Serious adverse events
    		 All randomised patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All randomised patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 6 (66.67%)
    General disorders and administration site conditions
    Influenza like illness
    Additional description: MedDRA LLT - Flu like symptoms
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal mucosal disorder
    Additional description: MedDRA LLT - Nasal Mucosal Erythema
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Epistaxis
    Additional description: MedDRA LLT - Nasal mucus blood tinged
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
    Additional description: MedDRA LLT - Cold
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Nasal herpes
    Additional description: MedDRA LLT - Nasal herpes
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1

    More information

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

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    21 Apr 2015
    Study terminated by the Sponsor because of recruitment difficulties - only 6 subjects recruited in 6 months compared to the expected number of 60-100 in the same period.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Because the study was terminated early with only 6 subjects randomised compared to the planned sample size of 32 evaluable subjects, no comparative analyses of DERC vs. the Placebo were conducted. Only simple data summaries are available.
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    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.

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