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   43865   clinical trials with a EudraCT protocol, of which   7286   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:
    A placebo controlled evaluation of a developmental gel for the treatment of atopic eczema.

    Summary
    EudraCT number
    		 2011-004184-79
    Trial protocol
    		 GB  
    Global end of trial date
    08 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jul 2016
    First version publication date
    31 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NIAD-01
    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
    Amanda Wigens, Dermal Laboratories Limited, 0044 01462458866, clinical@dermal.co.uk
    Scientific contact
    Amanda Wigens, Dermal Laboratories Limited, 0044 01462458866, 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 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to find out whether the 4% nicotinamide gel (NIAD Gel) offers therapeutically relevant treatment of mild to moderate atopic eczema compared to placebo, using a bilateral (within subject comparison) study design. If the active gel is beneficial in treating the very itchy, red and inflamed ‘flared’ atopic eczema skin areas, this may help us develop a new product which can help reduce the impact of atopic eczema on the lives of patients and their families. This study was powered for two endpoints: the difference between the improvement from baseline Investigator Global Assessment (IGA) for the NIAD Gel treated areas compared to the Placebo treated areas after the 4 weeks treatment period, and the change from baseline Three Item Severity Score (TISS = erythema + oedema + excoriation) for the NIAD treated areas compared to the Placebo treated areas after the 4 week treatment period.
    Protection of trial subjects
    Topical application of the product was consistent with standard care. The main risk to the participants presented by this research was that of the treatment (active and placebo) not working. This was mitigated by the chosen study design and methodology, which restricted the application of both active and placebo gels to relatively small areas of the body while allowing other topical treatments to continue elsewhere. Also, reported placebo effects are not uncommon in similar studies, therefore significant worsening of the skin condition on the treatment areas was not likely.
    Background therapy
    		 The use of the IMPs was restricted to the patient's volar forearms only. Elsewhere, they were allowed to carry on applying their usual topical treatments to manage their eczema.
    Evidence for comparator
    		 Use of a placebo comparison involving limited treatment areas only (the volar forearms) was chosen because this offers the advantages of scientific rigor (from placebo control) whilst also permitting patients to continue using their normal eczema treatments elsewhere; thereby minimising ethical issues associated with a placebo.
    Actual start date of recruitment
    10 Jun 2013
    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: 54
    Worldwide total number of subjects
    54
    EEA total number of subjects
    54
    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)
    7
    Adults (18-64 years)
    47
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Potential participants were primarily identified from a review of the study centre's patient volunteer database. In addition, a study poster/advert was displayed in local GP surgeries and other locations, in order to publicise the study to the wider community.

    Pre-assignment
    Screening details
    		 68 patients were screened of which 54 were consented and randomised into the study. Of these, 51 patients were included in the Intention-To-Treat (ITT) population used in the outcome analysis.

    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

    Arms
    Arm title
    		 Active and Placebo
    Arm description
    		 Bilateral design - all patients received active and placebo.
    Arm type
    		 Active and Placebo

    Investigational medicinal product name
    NIAD Gel
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The product was applied topically three times daily for four weeks. Patients were asked to apply a sufficient amount of gel to ensure complete coverage of the treatment area in the left or right volar forearm (from the front of the wrist to just above the creases of the elbow) with a thin film of the product.

    Investigational medicinal product name
    Placebo Gel
    Investigational medicinal product code
    PL1
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The product was applied topically three times daily for four weeks. Patients were asked to apply a sufficient amount of gel to ensure complete coverage of the treatment area in the other volar forearm (from the front of the wrist to just above the creases of the elbow) with a thin film of the product.

    Number of subjects in period 1
    		Active and Placebo
    Started
    54
    Baseline to 2 weeks
    50
    2 weeks to 4 weeks
    50
    Completed
    50
    Not completed
    4
         No longer able to attend appointments
    2
         Lost to follow-up
    1
         Lack of efficacy
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All randomised patients.

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 54 54
    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)
    		 7 7
        Adults (18-64 years)
    		 47 47
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 37 37
        Male
    		 17 17
    Ethnic group
    Units: Subjects
        Caucasian
    		 52 52
        Asian
    		 2 2
    Solar skin type
    Units: Subjects
        White (always burns never tans)
    		 14 14
        White (usually burns tans with difficulty)
    		 11 11
        Cream (sometimes mild burn gradually tans)
    		 27 27
        Brown (rarely burns tans with ease)
    		 1 1
        Dark brown (very rarely burns tans very easily)
    		 1 1
        Black (never burns tans very easily)
    		 0 0
    Subject analysis sets

    Subject analysis set title
    ITT analysis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention-to-treat (ITT) analysis set.

    Subject analysis set title
    N/A (bilateral study design)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Bilateral design - all patients received active and placebo.

    Subject analysis sets values
    		 ITT analysis set N/A (bilateral study design)
    Number of subjects
    51
    51
    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)
    6
        Adults (18-64 years)
    45
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    34
        Male
    17
    Ethnic group
    Units: Subjects
        Caucasian
    49
        Asian
    2
    Solar skin type
    Units: Subjects
        White (always burns never tans)
    12
        White (usually burns tans with difficulty)
    10
        Cream (sometimes mild burn gradually tans)
    27
        Brown (rarely burns tans with ease)
    1
        Dark brown (very rarely burns tans very easily)
    1
        Black (never burns tans very easily)
    0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Active and Placebo
    Reporting group description
    		 Bilateral design - all patients received active and placebo.

    Subject analysis set title
    ITT analysis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention-to-treat (ITT) analysis set.

    Subject analysis set title
    N/A (bilateral study design)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Bilateral design - all patients received active and placebo.

    Primary: Baseline improvement IGA, NIAD arm minus Placebo arm

    		 Close Top of page
    End point title
    		 Baseline improvement IGA, NIAD arm minus Placebo arm
    End point description
    The primary endpoint is the difference between the improvement from baseline Investigator Global Assessment (IGA) for the NIAD Gel treated areas compared to the Placebo treated areas after the 4 weeks treatment period.
    End point type
    Primary
    End point timeframe
    Difference in improvement from baseline to final assessment (after 4 weeks of treatment).
    End point values
    		 ITT analysis set N/A (bilateral study design)
    Number of subjects analysed
    51
    51 [1]
    Units: percent
    number (not applicable)
        -2 (placebo arm improved more)
    0
    0
        -1 (placebo arm improved more)
    12
    0
        0 (both arms same improvement)
    57
    0
        +1 (NIAD arm improved more)
    25
    0
        +2 (NIAD arm improved more)
    4
    0
        Missing
    2
    0
    Attachments
    		 Primary outcome
    Notes
    [1] - Bilateral design - all patients received active and placebo.
    Statistical analysis title
    		 Primary outcome
    Statistical analysis description
    The number of subjects included in this analysis is 51 (not 102), this is because it is a bilateral study.
    Comparison groups
    ITT analysis set v N/A (bilateral study design)
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.032 [3]
    Method
    		 Wilcoxon signed ranks test
    Confidence interval
    Notes
    [2] - Analysed on a paired basis to reflect the bilateral study design.
    [3] - Significant at 5% level (2-sided).

    Secondary: Baseline improvement TISS, NIAD arm minus Placebo arm

    		 Close Top of page
    End point title
    		 Baseline improvement TISS, NIAD arm minus Placebo arm
    End point description
    The secondary outcome is the change from baseline Three Item Severity Score (TISS) for the NIAD treated areas compared to the Placebo treated areas after the 4 week treatment period. TISS is the sum of the SCORAD intensity item scores for Erythema, Oedema/papulation and Excoriations/scratches (each on a 0 to 3 scale).
    End point type
    Secondary
    End point timeframe
    Difference in improvement from baseline to final assessment (after 4 weeks of treatment).
    End point values
    		 ITT analysis set N/A (bilateral study design)
    Number of subjects analysed
    51
    51 [4]
    Units: Mean improvement in TISS score
    least squares mean (confidence interval 95%)
        NIAD minus Placebo (adjusted mean and 95% CI)
    0.31 (0.01 to 0.61)
    0 (0 to 0)
    Notes
    [4] - Bilateral design - all patients received active and placebo.
    Statistical analysis title
    		 Secondary outcome
    Statistical analysis description
    This endpoint was analysed by fitting the data using a mixed model taking into account the bilateral study design, with baseline TISS as covariate, randomised group, arm and treatment as fixed effects and subject as a random effect. The treatment effect was assessed using the within subject error term and the arm effect was assessed using the between subject error term. The number of subjects included in this analysis is 51 (not 102), this is because it is a bilateral study.
    Comparison groups
    ITT analysis set v N/A (bilateral study design)
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04 [5]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [5] - Significant at 5% level (2-sided).

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Baseline to 6 weeks (this includes 2 weeks late onset).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 As reported in CRF
    Dictionary version
    N/A
    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 / 54 (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
    20 / 54 (37.04%)
    Skin and subcutaneous tissue disorders
    Worsening/flare of eczema
    Additional description: Adverse events probably or possibly related to NIAD and/or Placebo.
         subjects affected / exposed
    7 / 54 (12.96%)
         occurrences all number
    7
    Redness of skin/Dryness of skin/Itching/Increased papulation
    Additional description: Adverse events probably or possibly related to NIAD and/or Placebo.
         subjects affected / exposed
    8 / 54 (14.81%)
         occurrences all number
    14
    Stinging (or 'nip')
    Additional description: Adverse events probably or possibly related to NIAD and/or Placebo.
         subjects affected / exposed
    11 / 54 (20.37%)
         occurrences all number
    11

    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 reported
    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 Apr 28 23:42:37 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA