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    Clinical Trial Results:
    Evaluation of the protection activity of microfine Ti02, pigmentary Ti02 and bisoctrizole and their combinations in voluntary patients with idiopathic solar urticaria (SU): phase II photoprovocation test.

    Summary
    EudraCT number
    		 2007-000911-27
    Trial protocol
    		 GB  
    Global end of trial date
    22 Apr 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Aug 2016
    First version publication date
    18 Jun 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • New data added to full data set
    As the study was linked to a PIP, and despite PIP removal, replacement of the clinical study report synopsis by the study data sets.

    Trial information

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    Trial identification
    Sponsor protocol code
    V00096 CR 205 (ORF)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Orfagen
    Sponsor organisation address
    3, avenue Hubert Curien, Toulouse CEDEX 1, France,
    Public contact
    Clinical project manager, Orfagen, info@orfagen.com
    Scientific contact
    Clinical project manager, Orfagen, info@orfagen.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000585-PIP01-09
    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
    25 Mar 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Apr 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, Tinosorb MBBT) and their respective combinations.
    Protection of trial subjects
    Patients benefit from thorough clinical examination. Local and systemic adverse effects were searched and monitored throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jan 2008
    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: 5
    Country: Number of subjects enrolled
    United States: 10
    Worldwide total number of subjects
    15
    EEA total number of subjects
    5
    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)
    12
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 After check of compliance with inclusion / non inclusion criteria, and after a wash-out period for patients who received potientally interfering treatments, patients were included in the study period (eg. 2 days for emolliant on back; 7 days for topical corticosteroids; 4 weeks for immunosuppressive agents;2 days for antihistaminiques) .

    Period 1
    Period 1 title
    Study Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Investigator, Monitor, Data analyst, Assessor [2]
    Blinding implementation details
    Because the test materials were not matched in appearance, a double-blind procedure cannot be applied . Accordingly, the assessment parameters (e.g. reading) were evaluated by the investigator who was masked to the test allocation sites.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 V0096 CR vehicle
    Arm description
    		 In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.
    Arm type
    		 Placebo

    Investigational medicinal product name
    V0096 CR vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    2mg/cm2. Single application of the test materials (total of 8 treated sites) prior to irradiation using a solar simulator.

    Arm title
    		 Ti02 microfine 12.15% alone
    Arm description
    		 In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ti02 microfine 12.15% alone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    2mg/cm2. Single application of the test materials (total of 8 treated sites) prior to irradiation using a solar simulator.

    Arm title
    		 Ti02 pigmentary 3% alone
    Arm description
    		 In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ti02 pigmentary 3% alone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    2mg/cm2. Single application of the test materials (total of 8 treated sites) prior to irradiation using a solar simulator.

    Arm title
    		 Bisoctrizole 10% alone
    Arm description
    		 In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bisoctrizole 10% alone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    2mg/cm2. Single application of the test materials (total of 8 treated sites) prior to irradiation using a solar simulator.

    Arm title
    		 Combination of Ti02 microfine 12.15% + Ti02 pigmentary 3%
    Arm description
    		 In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Combination of Ti02 microfine 12.15% + Ti02 pigmentary 3%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    2mg/cm2. Single application of the test materials (total of 8 treated sites) prior to irradiation using a solar simulator.

    Arm title
    		 Combination of Ti02 microfine 12.15% + bisoctrizole 10%
    Arm description
    		 In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Combination of Ti02 microfine 12.15% + bisoctrizole 10%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    2mg/cm2. Single application of the test materials (total of 8 treated sites) prior to irradiation using a solar simulator.

    Arm title
    		 Combination of Ti02 pigmentary 3% + bisoctrizole 10%
    Arm description
    		 In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Combination of Ti02 pigmentary 3% + bisoctrizole 10%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    2mg/cm2. Single application of the test materials (total of 8 treated sites) prior to irradiation using a solar simulator.

    Arm title
    		 V0096: Test product
    Arm description
    		 The test product is a combination of Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% . In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Test product
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    2mg/cm2. Single application of the test materials (total of 8 treated sites) prior to irradiation using a solar simulator.

    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: because the test materials containing TiO2 microfine alone, TiO2 pigmentary alone, bisoctrizole alone, and their combinations are not matched in appearance, a double-blind procedure cannot be applied. Accordingly, the assessment parameters will be evaluated by the investigator who will be masked to the test allocation sites
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: because the test materials containing TiO2 microfine alone, TiO2 pigmentary alone, bisoctrizole alone, and their combinations are not matched in appearance, a double-blind procedure cannot be applied. Accordingly, the assessment parameters will be evaluated by the investigator who will be masked to the test allocation sites
    Number of subjects in period 1
    		V0096 CR vehicle Ti02 microfine 12.15% alone Ti02 pigmentary 3% alone Bisoctrizole 10% alone Combination of Ti02 microfine 12.15% + Ti02 pigmentary 3% Combination of Ti02 microfine 12.15% + bisoctrizole 10% Combination of Ti02 pigmentary 3% + bisoctrizole 10% V0096: Test product
    Started
    15
    15
    15
    15
    15
    15
    15
    15
    Completed
    14
    14
    14
    14
    14
    14
    14
    14
    Not completed
    1
    1
    1
    1
    1
    1
    1
    1
         Consent withdrawn by subject
    1
    1
    1
    1
    1
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study Period
    Reporting group description
    		 Total population

    Reporting group values
    		 Study Period Total
    Number of subjects
    		 15 15
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 12
        From 65-84 years
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    V0096 CR vehicle
    Reporting group description
    		 In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.

    Reporting group title
    Ti02 microfine 12.15% alone
    Reporting group description
    		 In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.

    Reporting group title
    Ti02 pigmentary 3% alone
    Reporting group description
    		 In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.

    Reporting group title
    Bisoctrizole 10% alone
    Reporting group description
    		 In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.

    Reporting group title
    Combination of Ti02 microfine 12.15% + Ti02 pigmentary 3%
    Reporting group description
    		 In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.

    Reporting group title
    Combination of Ti02 microfine 12.15% + bisoctrizole 10%
    Reporting group description
    		 In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.

    Reporting group title
    Combination of Ti02 pigmentary 3% + bisoctrizole 10%
    Reporting group description
    		 In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.

    Reporting group title
    V0096: Test product
    Reporting group description
    		 The test product is a combination of Ti02 microfine 12.15% + Ti02 pigmentary 3% + bisoctrizole 10% . In order to compare the photoprotection activity of the 3 active ingredients alone (microfine TiO2, pigmentary TiO2, bisoctrizole) of the test and their respective combinations, each product was applied on randomised test areas before exposition to 1 Minimal Urticarial Dose (MUD), 3 MUD, 5 MUD, 7 MUD.

    Primary: Photodermatosis Protection Factor (PPF)

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    End point title
    		 Photodermatosis Protection Factor (PPF) [1]
    End point description
    The PPF for each test product was calculated by dividing the MUD of the protected skin by the MUD of the unprotected skin, in each treatment group.
    End point type
    Primary
    End point timeframe
    MUD reading 30 min after test product removal. (Application of test product => 15 min later: phototesting with 1 MUD, 3 MUD, 5 MUD or 7 MUD => removal of test product => 30 min later: reading of the MUD)
    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: 8 different products applied on different test areas.
    End point values
    		 V0096 CR vehicle Ti02 microfine 12.15% alone Ti02 pigmentary 3% alone Bisoctrizole 10% alone Combination of Ti02 microfine 12.15% + Ti02 pigmentary 3% Combination of Ti02 microfine 12.15% + bisoctrizole 10% Combination of Ti02 pigmentary 3% + bisoctrizole 10% V0096: Test product
    Number of subjects analysed
    15
    15
    15
    15
    15
    15
    15
    15
    Units: PPF
        arithmetic mean (standard error)
    1.93 ( 0.27 )
    3.27 ( 0.7 )
    2.33 ( 0.42 )
    3.53 ( 0.72 )
    3.67 ( 0.69 )
    3.8 ( 0.75 )
    3.93 ( 0.75 )
    4.33 ( 0.64 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Whole study duration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Randomised patients
    Reporting group description
    		 -

    Serious adverse events
    		 Randomised patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Randomised patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 15 (6.67%)
    Skin and subcutaneous tissue disorders
    Urticaria thermal
         subjects affected / exposed
    1 / 15 (6.67%)
         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? 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.

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