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    Clinical Trial Results:
    Efficacy and tolerance of Tazarotene cream in lamellar ichthyosis (LI): a dose-finding study.

    Summary
    EudraCT number
    		 2006-006878-22
    Trial protocol
    		 FR   DE  
    Global end of trial date
    20 Apr 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    05 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
    R00002 CR 201 (ORF)
    Additional study identifiers
    ISRCTN number
    		 ISRCTN86666250
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Orfagen
    Sponsor organisation address
    3, avenue Hubert Curien, Toulouse CEDEX 1, France, 31035
    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-000510-PIP02-10
    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
    13 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Apr 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Apr 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To assess and compare the short-term efficacy of Tazarotene 0.05% and 0.1% vehicled in an emollient cream in LI patients.
    Protection of trial subjects
    Included patients benefited from close management of their disease, with weekly visits during the treatment period and fortnightly visits during the treatment free follow-up period. During visits, a thorough clinical examination, as well as a paraclinical examination at baseline and on Day 28, were performed. Local and systemic adverse effects were searched and monitored throughout the study. Blood samplings for routine laboratory tests and for plasmatic dosage of tazarotenic acid were performed only at baseline and on Day 28, sampling about 33 mL of blood in adults and about 20 mL in children. Blood samples were repeated for follow-up only when clinically significant abnormal values were observed. A standard moisturizer was applied at least once a day on all sites at distance from the test products application. In order to avoid any risk of teratogenicity inherent to retinoid exposure, women of childbearing potential had to stay under reliable contraception and to use condom in addition, up to at least 8 weeks after their last test product application. Women of childbearing potential with no reliable contraception were excluded from the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Feb 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
    France: 11
    Country: Number of subjects enrolled
    Germany: 19
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    7
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    20
    From 65 to 84 years
    0
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Selected patients performed a wash-out period of 7 to 28 days, during which patients were treated only with a standard moisturizer provided by the sponsor, before assessment of their inclusion/exclusion criteria and enrollment in the study period.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 R0002CR 0.05% / Placebo
    Arm description
    		 Patients who applied the active R0002CR 0.05% and Vehicle cream on two randomly designated test sides (left and right side of the body).
    Arm type
    		 Experimental lower dosage / placebo

    Investigational medicinal product name
    R0002CR 0.05%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Application of R0002CR 0.05% on one randomly allocated sides (left side or right side of the body) once daily for 4 weeks (e.g. every evening).

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Application of vehicle cream on the other randomly allocated side (left side or right side of the body) once daily for 4 weeks (e.g. every evening).

    Arm title
    		 R0002CR 0.1% / Placebo
    Arm description
    		 Patients who applied the active R0002CR 0.1% and Vehicle cream on two randomly designated test sides (left and right side of the body).
    Arm type
    		 Experimental higher dosage / placebo

    Investigational medicinal product name
    R0002CR 0.1%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Application of R0002CR 0.1% on one randomly allocated sides (left side or right side of the body) once daily for 4 weeks (e.g. every evening).

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Application of vehicle cream on the other randomly allocated side (left side or right side of the body) once daily for 4 weeks (e.g. every evening).

    Number of subjects in period 1
    		R0002CR 0.05% / Placebo R0002CR 0.1% / Placebo
    Started
    15
    15
    Completed
    15
    15
    Period 2
    Period 2 title
    Period II
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 R0002CR 0.05% / Treatment free
    Arm description
    		 Treatment-free follow-up of remitting lesions at Period II entry (lesions treated with R0002CR 0.05% during period I).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 R0002CR 0.1% / Treatment free
    Arm description
    		 Treatment-free follow-up of remitting lesions at Period II entry (lesions treated with R0002CR 0.1% during period I).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo / Treatment free
    Arm description
    		 Treatment-free follow-up of remitting lesions at Period II entry (lesions treated with vehicle during period I).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2 [1]
    		R0002CR 0.05% / Treatment free R0002CR 0.1% / Treatment free Placebo / Treatment free
    Started
    8
    9
    4
    Completed
    7
    9
    4
    Not completed
    1
    0
    0
         Consent withdrawn by subject
    1
    -
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Treatment free Period II: body sides with remitting lesions only entered the Period II.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    R0002CR 0.05% / Placebo
    Reporting group description
    		 Patients who applied the active R0002CR 0.05% and Vehicle cream on two randomly designated test sides (left and right side of the body).

    Reporting group title
    R0002CR 0.1% / Placebo
    Reporting group description
    		 Patients who applied the active R0002CR 0.1% and Vehicle cream on two randomly designated test sides (left and right side of the body).

    Reporting group values
    		 R0002CR 0.05% / Placebo R0002CR 0.1% / Placebo Total
    Number of subjects
    		 15 15 30
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 26.1 ( 12.6 ) 33.5 ( 23.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 5 13
        Male
    		 7 10 17

    End points

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    End points reporting groups
    Reporting group title
    R0002CR 0.05% / Placebo
    Reporting group description
    		 Patients who applied the active R0002CR 0.05% and Vehicle cream on two randomly designated test sides (left and right side of the body).

    Reporting group title
    R0002CR 0.1% / Placebo
    Reporting group description
    		 Patients who applied the active R0002CR 0.1% and Vehicle cream on two randomly designated test sides (left and right side of the body).
    Reporting group title
    R0002CR 0.05% / Treatment free
    Reporting group description
    		 Treatment-free follow-up of remitting lesions at Period II entry (lesions treated with R0002CR 0.05% during period I).

    Reporting group title
    R0002CR 0.1% / Treatment free
    Reporting group description
    		 Treatment-free follow-up of remitting lesions at Period II entry (lesions treated with R0002CR 0.1% during period I).

    Reporting group title
    Placebo / Treatment free
    Reporting group description
    		 Treatment-free follow-up of remitting lesions at Period II entry (lesions treated with vehicle during period I).

    Subject analysis set title
    R0002CR 0.05% (R0002CR 0.05% / Placebo group)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Answer on body lesions treated with R0002CR 0.05% (patients from R0002CR 0.05% / Placebo group).

    Subject analysis set title
    R0002CR 0.1% (R0002CR 0.1% / Placebo group)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Answer on body lesions treated with R0002CR 0.1% (patients from R0002CR 0.1% / Placebo group).

    Subject analysis set title
    Placebo (R0002CR 0.05% / Placebo group)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Answer on body lesions treated with vehicle cream (patients from R0002CR 0.05% / Placebo group).

    Subject analysis set title
    Placebo (R0002CR 0.1% / Placebo group)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Answer on body lesions treated with vehicle cream (patients from R0002CR 0.1% / Placebo group).

    Primary: Responder for scaling and roughness

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    End point title
    		 Responder for scaling and roughness [1]
    End point description
    End point type
    Primary
    End point timeframe
    End of Period I
    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: Pairwise comparisons R0002CR 0.05% vs. Vehicle and R0002CR 0.1% vs. Vehicle: A statistically significant difference was achieved with each R0002CR group compared to vehicle group (p = 0.025). (no possibility to enter those data in EudraCT database).
    End point values
    		 R0002CR 0.05% (R0002CR 0.05% / Placebo group) R0002CR 0.1% (R0002CR 0.1% / Placebo group) Placebo (R0002CR 0.05% / Placebo group) Placebo (R0002CR 0.1% / Placebo group)
    Number of subjects analysed
    15
    15
    15
    15
    Units: Responders
    6
    8
    1
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From study beginning to study end.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    R0002CR 0.05% - Period I
    Reporting group description
    		 For safety analyses on Period I and Period II, a patient was considered in the two treatment groups corresponding to the two study treatments administered during the Period I on his/her left test side and on his/her right test side respectively.

    Reporting group title
    R0002CR 0.1% - Period I
    Reporting group description
    		 For safety analyses on Period I and Period II, a patient was considered in the two treatment groups corresponding to the two study treatments administered during the Period I on his/her left test side and on his/her right test side respectively.

    Reporting group title
    Placebo - Period I
    Reporting group description
    		 For safety analyses on Period I and Period II, a patient was considered in the two treatment groups corresponding to the two study treatments administered during the Period I on his/her left test side and on his/her right test side respectively.

    Reporting group title
    R0002CR 0.05% - Period II
    Reporting group description
    		 For safety during Period II, patients were analyzed according to the study treatment(s) actually received during the Period I (i.e. “as treated”).

    Reporting group title
    R0002CR 0.1% - Period II
    Reporting group description
    		 For safety during Period II, patients were analyzed according to the study treatment(s) actually received during the Period I (i.e. “as treated”).

    Reporting group title
    Placebo - Period II
    Reporting group description
    		 For safety during Period II, patients were analyzed according to the study treatment(s) actually received during the Period I (i.e. “as treated”).

    Serious adverse events
    		 R0002CR 0.05% - Period I R0002CR 0.1% - Period I Placebo - Period I R0002CR 0.05% - Period II R0002CR 0.1% - Period II Placebo - Period II
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 R0002CR 0.05% - Period I R0002CR 0.1% - Period I Placebo - Period I R0002CR 0.05% - Period II R0002CR 0.1% - Period II Placebo - Period II
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 15 (80.00%)
    12 / 15 (80.00%)
    10 / 30 (33.33%)
    2 / 8 (25.00%)
    0 / 9 (0.00%)
    1 / 17 (5.88%)
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Foot fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    Hyperaesthesia
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    Burning sensation
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    1 / 30 (3.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    4
    2
    2
    0
    0
    0
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    0 / 15 (0.00%)
    3 / 15 (20.00%)
    3 / 30 (10.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    3
    5
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Skin irritation
         subjects affected / exposed
    6 / 15 (40.00%)
    5 / 15 (33.33%)
    0 / 30 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    9
    11
    0
    1
    0
    0
    Skin erosion
         subjects affected / exposed
    1 / 15 (6.67%)
    2 / 15 (13.33%)
    1 / 30 (3.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    3
    1
    0
    0
    1
    Erythema
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 30 (3.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Pain of skin
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Prurigo
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 30 (3.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Skin fissures
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    1 / 30 (3.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    Skin lesion
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 30 (3.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Rash
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Actinic keratosis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Eczema
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Skin infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    Superinfection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Mar 2008
    - Extension of the study period . - Use of plastic gloves for test product applications. - Change in German and French co-investigators. - Addition of the ISCRTN number.
    06 May 2008
    - Extension of the study period. - Addition of an 11th centre. - Notify a change of German co-investigators
    20 Jan 2009
    - Extension of the study period. - Update of the Helsinki declaration.

    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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