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    Clinical Trial Results:
    Topical brimonidine reduces IPL-induced erythema without affecting efficacy: a randomized controlled trial in patients with facial telangiectasias

    Summary
    EudraCT number
    		 2015-004789-27
    Trial protocol
    		 DK  
    Global end of trial date
    13 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jan 2018
    First version publication date
    19 Jan 2018
    Other versions
    Summary report(s)
    		 Abstract

    Trial information

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    Trial identification
    Sponsor protocol code
    21.November.2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02761174
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 H-15018114: ID-number: 16/8/76
    Sponsors
    Sponsor organisation name
    Bispebjerg Hospital
    Sponsor organisation address
    Bispebjerg bakke 23, København NV, Denmark, 2400
    Public contact
    Dermatologisk Afdeling, Bispebjerg Hospital, 0045 20736670, acvissing@gmail.com
    Scientific contact
    Dermatologisk Afdeling, Bispebjerg Hospital, 0045 20736670, acvissing@gmail.com
    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
    29 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We aimed at investigating, whether topical brimonidine could reduce IPL- induced post-inflammatory response in terms of erythema, oedema and pain in patients with facial telangiectasias.
    Protection of trial subjects
    Treatments were performed by highly trained dermatologist and study assistants applied brimonidine at the hospital, where patients were observed for more than 30 minutes after.
    Background therapy
    		 Same procedure followed after each of 3 facial Intense Pulsed Light (IPL) treatments, given at 3-week intervals. Patients received IPL to both sides of the face (allocated side and control side) using PR applicator with wavelength bands of 530-750 nm and spot size 10x48 mm. Colourless gel was applied before IPL on treatment areas to optimize optical coupling between the light guide and the skin. Similar IPL-settings were applied between facial sides to induce equal immediate IPL-responses guided by clinical endpoints of erythema, vasoconstriction or transient purpura.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Mar 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 10
    Country: Number of subjects enrolled
    Belgium: 9
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    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)
    17
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Inclusion criteria were patients with symmetrical distribution of moderate to severe facial telangiectasias, based on clinical photo-guidelines. Males and females at 18-65 years old with Fitzpatrick skin types I-III were included.

    Pre-assignment
    Screening details
    		 Inclusion criteria were patients with symmetrical distribution of moderate to severe facial telangiectasias, based on clinical photo-guidelines. Males and females at 18-65 years old with Fitzpatrick skin types I-III were included. All fertile women documented non-reactive urine pregnancy test at the day of inclusion and used effective birth control

    Pre-assignment period milestones
    Number of subjects started
    		 19
    Intermediate milestone: Number of subjects
    baseline, 1. treatment: 19
    Intermediate milestone: Number of subjects
    the day after baseline: 19
    Intermediate milestone: Number of subjects
    2. treatment: 19
    Intermediate milestone: Number of subjects
    3. treatment: 19
    Intermediate milestone: Number of subjects
    final follow-up: 19
    Number of subjects completed
    		 19

    Period 1
    Period 1 title
    Baseline to follow-up (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Data analyst, Assessor [2]
    Blinding implementation details
    Randomization was conducted with consecutively numbered, closed, non-transparent envelopes containing a computer-generated allocation. Envelopes were opened in a numeric order immediately before first treatment. The envelope contained either the letter L (left) or R (right), indicating the facial side receiving topical brimonidine.

    Arms
    Arm title
    		 Brimonidine and air-cooling (treatment) vs air-cooling alone
    Arm description
    		 The trial was a split-face trial, thus patients were their own control in which one side of the face received topical brimonidine and air-cooling and the other side air-cooling alone (control)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Brimonidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    pea sized amount

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Evaluator and data analyst was blinded to treatment, while patients and study assistants that applied brimonidine were not
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Evaluator and data analyst was blinded to treatment, while patients and study assistants that applied brimonidine were not
    Number of subjects in period 1
    		Brimonidine and air-cooling (treatment) vs air-cooling alone
    Started
    19
    baseline, 1. treatment
    19
    The day after the first treatment
    19
    2. treatment, 3-weeks after baseline
    19
    3. treatment, 6 weeks after baseline
    19
    Follow-up, 10 weeks after baseline
    19
    Completed
    19

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline to follow-up
    Reporting group description
    		 -

    Reporting group values
    		 Baseline to follow-up Total
    Number of subjects
    		 19 19
    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)
    		 17 17
        From 65-84 years
    		 2 2
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 6 6
    Subject analysis sets

    Subject analysis set title
    brimonidine and air-cooling vs. air-cooling alone
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    NOTE!! This was an intra-individual split-face trial, where patients were their own control. Therefor NOT 38 patients BUT in total 19 patients were included in full analysis

    Subject analysis sets values
    		 brimonidine and air-cooling vs. air-cooling alone
    Number of subjects
    19
    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)
    17
        From 65-84 years
    2
        85 years and over
    0
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    13
        Male
    6

    End points

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    End points reporting groups
    Reporting group title
    Brimonidine and air-cooling (treatment) vs air-cooling alone
    Reporting group description
    		 The trial was a split-face trial, thus patients were their own control in which one side of the face received topical brimonidine and air-cooling and the other side air-cooling alone (control)

    Subject analysis set title
    brimonidine and air-cooling vs. air-cooling alone
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    NOTE!! This was an intra-individual split-face trial, where patients were their own control. Therefor NOT 38 patients BUT in total 19 patients were included in full analysis

    Primary: clinical on-site evaluation of erythema and oedema

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    End point title
    		 clinical on-site evaluation of erythema and oedema
    End point description
    Blinded clinical on-site evaluation of erythema and oedema were assessed separately on a validated 5-point scale and 4-point scale, respectively by the same blinded-evaluators at each site
    End point type
    Primary
    End point timeframe
    primary outcomes were evaluated separately for brimonidine and control side immediately after each of the 3 IPL-treatment and at 30-60 minutes after incubation of brimonidine and were further evaluated the day after the first treatment and at follow-up
    End point values
    		 Brimonidine and air-cooling (treatment) vs air-cooling alone brimonidine and air-cooling vs. air-cooling alone
    Number of subjects analysed
    19
    19
    Units: 0-4, 0-3
    19
    19
    Attachments
    		 summary
    Statistical analysis title
    		 non-parametric Wilcoxon signed rank test
    Statistical analysis description
    Brimonidine and air-cooling was compared to air-cooling alone, in this split-face intra-individual study where patients were there own control
    Comparison groups
    Brimonidine and air-cooling (treatment) vs air-cooling alone v brimonidine and air-cooling vs. air-cooling alone
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon signed rank test
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Notes
    [1] - non-parametric Wilcoxon signed rank test

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the whole study
    Adverse event reporting additional description
    No adverse events directly attributable to topical brimonidine were observed during trial period. IPL-treatment induced superficial wounds after application of fluences higher than median levels in three patients on both brimonidine and control sides that resolved before follow-up.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 superficial wounds
    Dictionary version
    1
    Reporting groups
    Reporting group title
    patients
    Reporting group description
    		 -

    Serious adverse events
    		 patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (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
    		 patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No adverse events directly attributable to topical brimonidine were observed during trial period. IPL-treatment induced superficial wounds after application of fluences higher than median levels in three patients on both brimonidine and control sides that resolved before follow-up.

    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? No

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