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    Clinical Trial Results:
    An intra-individual randomized controlled study to evaluate the efficacy and tolerance of the product RV4421A BS0042 in association with a moderately potent topical corticosteroid in adults with Atopic Dermatitis

    Summary
    EudraCT number
    		 2014-002194-10
    Trial protocol
    		 DE  
    Global end of trial date
    09 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Dec 2018
    First version publication date
    12 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RV4421A2013147
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pierre Fabre Dermo Cosmétique
    Sponsor organisation address
    45 place Abel Gance, Boulogne, France, 92654
    Public contact
    not applicable, proDERM GmbH, AHougardy@proDERM.de
    Scientific contact
    not applicable, proDERM GmbH, AHougardy@proDERM.de
    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
    24 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective will be to evaluate the benefit of the association of the product RV4421A BS0042 with a moderately potent topical corticosteroid compared with the moderately potent topical corticosteroid alone, in improvement of Atopic Dermatitis in adults, measured by the reduction of L-SCORAD at Day 3 (D3).
    Protection of trial subjects
    This study was performed in accordance with the principles stated in the Declaration of Helsinki (1964) and subsequent amendments, and in accordance with the EN ISO 14155 (2011) and national regulations. The protocol and related documents (including the informed consent form) were submitted for approval to an independent Ethics Committees before the study set up, according to national régulations. The first application of the associated product and test product was performed at investigational centre under the study personnel control in order to explain the way of use to the patient and to evaluate the immediate local tolerance. Additionally to the test product (on one arm or leg), all patients received on both arms or legs an activetreatment by an appropriate, representative, widely used and in the European Union (EU) approved TCS for 10 days.
    Background therapy
    		 No other therapy was used during the trial. The patient was allowed to apply any topical medication on face and body, except on both study arms or legs. For instance, topical treatments prescribed by the investigator for the other AD lesions than those on study arms or legs were allowed throughout the duration of the study. During the 2nd period of the study (from D10 to D24), in case of worsening of lesions on one/both arm(s) or leg(s) leading to the need of a product application, the patient was authorized to apply any product on his/her suitable arm(s) or leg(s).
    Evidence for comparator
    		 According to several guidelines for treatment of Atopic Dermatitis, potent steroids should be avoided and moderately potent Topical Corticosteroids (TCS) are recommended on areas where the skin is already thin, such as flexures. Desonide 0.1 % cream (LOCAPRED) has been chosen as TCS because it is one of the most prescribed TCS in France and it is commercialized in most of Europe.
    Actual start date of recruitment
    01 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
    Germany: 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)
    0
    Adults (18-64 years)
    54
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This superiority clinical study was conducted as a European, multicentre, randomized, open-label, controlled, intra-individual(right/left arm/leg) trial on 54 adults with moderate to severe AD with symmetric lesions on arms or popliteal fossa. All patients were recruited in 4 centres in Germany

    Pre-assignment
    Screening details
    		 The patients with a phototype > IV were not included in the study because of difficulties in assessing the local tolerance of the products on darker skin.

    Period 1
    Period 1 title
    First Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 First Group
    Arm description
    		 Left arm/popliteal fossa: twice daily application of the product RV4421A BS0042 in association with once daily application of TCS on the AD lesions (10 days) Right arm/ popliteal fossa: once daily application of TCS alone on the AD lesions
    Arm type
    		 Experimental

    Investigational medicinal product name
    RV4421A-BS0042
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The test product had to be applied twice daily (morning and evening) on lesions of only one study arm or popliteal fossa according to randomization, after the associated product, if applicable. One fingertip unit of test product had to be applied on only one arm or popliteal fossa, at each application. If the patient presented other lesions on the same arm or the same leg, he would also apply the test product on these lesions. The first application of test product was performed at the investigational centre.

    Investigational medicinal product name
    topical corticosteroid (TCS)
    Investigational medicinal product code
    Locapred 0.1%
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The TCS was applied once daily (evening only) on lesions of both study arms or popliteal fossa, before the test product if applicable. Two fingertip units of TCS were applied per study arm or popliteal fossa, at each application. If the patient presented other lesions on the study arm(s) or leg(s), he also applied the associated product on these lesions. The first application of TCS was performed at the investigational centre.

    Arm title
    		 Second Group
    Arm description
    		 Left arm/ popliteal fossa: once daily application of TCS alone on the AD lesions Right arm/ popliteal fossa: twice daily application of the product RV4421A BS0042 in association with once daily application of TCS on the AD lesions (10 days)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Topical corticosteroid
    Investigational medicinal product code
    Locapred 0.1%
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The TCS was applied once daily (evening only) on lesions of both study arms or popliteal fossa, before the test product if applicable. Two fingertip units of TCS were applied per study arm or popliteal fossa, at each application. If the patient presented other lesions on the study arm(s) or leg(s), he also applied the associated product on these lesions. The first application of TCS was performed at the investigational centre.

    Investigational medicinal product name
    RV4421A-BS0042
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The test product had to be applied twice daily (morning and evening) on lesions of only one study arm or popliteal fossa according to randomization, after the associated product, if applicable. One fingertip unit of test product had to be applied on only one arm or popliteal fossa, at each application. If the patient presented other lesions on the same arm or the same leg, he would also apply the test product on these lesions. The first application of test product was performed at the investigational centre.

    Number of subjects in period 1
    		First Group Second Group
    Started
    26
    28
    Completed
    23
    24
    Not completed
    3
    4
         Lack of efficacy
    3
    4
    Period 2
    Period 2 title
    Maintenance period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 First Group
    Arm description
    		 Left arm: twice daily application of the product RV4421A BS0042 (2 weeks). Right arm: not any product application (2 weeks).
    Arm type
    		 Experimental

    Investigational medicinal product name
    RV4421A-BS0042
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The test product had to be applied twice daily (morning and evening) on lesions of only one study arm or popliteal fossa according to randomization, after the associated product, if applicable. One fingertip unit of test product had to be applied on only one arm or popliteal fossa, at each application. If the patient presented other lesions on the same arm or the same leg, he would also apply the test product on these lesions. The first application of test product was performed at the investigational centre.

    Arm title
    		 Second Group
    Arm description
    		 Left arm: no product was applied during the maintenance phase in this arm (2 weeks) Right arm: twice daily application of the product RV4421A BS0042 (2 weeks)
    Arm type
    		 Experimental

    Investigational medicinal product name
    RV4421A-BS0042
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The test product had to be applied twice daily (morning and evening) on lesions of only one study arm or popliteal fossa according to randomization, after the associated product, if applicable. One fingertip unit of test product had to be applied on only one arm or popliteal fossa, at each application. If the patient presented other lesions on the same arm or the same leg, he would also apply the test product on these lesions. The first application of test product was performed at the investigational centre.

    Number of subjects in period 2
    		First Group Second Group
    Started
    23
    24
    Completed
    22
    24
    Not completed
    1
    0
         Personal Reason
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    First Period
    Reporting group description
    		 Fifty four patients with moderate to severe AD were included in the study. Fifty four patients were evaluated at D3 and D10, and 46 patients completed the study at D24. Eight patients discontinued during the study (before D24): 7 patients were not included in the 2nd period and 1 patient was withdrawn for a personal reason during the 2nd period.

    Reporting group values
    		 First Period Total
    Number of subjects
    		 54 54
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 54 54
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 26.06 ( 12.11 ) -
    Gender categorical
    Units: Subjects
        Female
    		 31 31
        Male
    		 23 23
    Phototype
    Description of the phototype classified with the Fitzpatrick scale
    Units: Subjects
        Phototype I
    		 1 1
        Phototype II
    		 16 16
        Phototype III
    		 26 26
        Phototype IV
    		 11 11
    L-IGA Score (Locapred alone)
    The Local Investigator's Global Assessment (L-IGA) score was assessed by the investigator independently on both study elbow creases/arms or popliteal fossa on a 6-point scale ranged from 0 (clear) to 5 (very severe disease).
    Units: Subjects
        Moderate Disease
    		 35 35
        Severe Disease
    		 19 19
    L-IGA Score (RV4421 + Locapred)
    The Local Investigator's Global Assessment (L-IGA) score was assessed by the investigator independently on both study elbow creases/arms or popliteal fossa on a 6-point scale ranged from 0 (clear) to 5 (very severe disease).
    Units: Subjects
        Moderate disease
    		 33 33
        Severe disease
    		 21 21

    End points

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    End points reporting groups
    Reporting group title
    First Group
    Reporting group description
    		 Left arm/popliteal fossa: twice daily application of the product RV4421A BS0042 in association with once daily application of TCS on the AD lesions (10 days) Right arm/ popliteal fossa: once daily application of TCS alone on the AD lesions

    Reporting group title
    Second Group
    Reporting group description
    		 Left arm/ popliteal fossa: once daily application of TCS alone on the AD lesions Right arm/ popliteal fossa: twice daily application of the product RV4421A BS0042 in association with once daily application of TCS on the AD lesions (10 days)
    Reporting group title
    First Group
    Reporting group description
    		 Left arm: twice daily application of the product RV4421A BS0042 (2 weeks). Right arm: not any product application (2 weeks).

    Reporting group title
    Second Group
    Reporting group description
    		 Left arm: no product was applied during the maintenance phase in this arm (2 weeks) Right arm: twice daily application of the product RV4421A BS0042 (2 weeks)

    Primary: L-SCORAD

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    End point title
    		 L-SCORAD
    End point description
    The LSCORAD is the sum of all SCORAD objective signs scores evaluated on a chosen target area. The SCORAD objective signs were: erythema, oedema/papulation, oozing/crusts, excoriation, lichenification and xerosis. For the primary efficacy criterion (L-SCORAD Index), if at least one evaluation was missing after the first evaluation of post product application, the LOCF method (Last Observation Carried Forward) was used to replace missing data.
    End point type
    Primary
    End point timeframe
    The primary criterion was the L-SCORAD index assessed independently on both elbow creases/study arms or popliteal fossa by the investigator on a scale ranged from 0 to 18, at Visit 2 (D3).
    End point values
    		 First Group Second Group
    Number of subjects analysed
    26
    28
    Units: not applicable
        number (not applicable)
    26
    28
    Statistical analysis title
    		 L-SCORAD
    Comparison groups
    First Group v Second Group
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0005
    Method
    		 ANCOVA
    Parameter type
    		 F statistic
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    At inclusion, any concomitant disease was reported. At each further visit, the occurrence of AE was determined by the patient’s spontaneous reporting, the investigator’s non-leading questioning and his/her clinical/dermatological evaluation.
    Adverse event reporting additional description
    The patient’s assessment had at least to take into account the following functional signs: burning sensation, warm sensation, itching/pruritus, tightness, stinging/prickling. The investigator and patient’s assessment had at least to take into account the following physical signs: redness/erythema swelling/oedema, desquamation, dryness, vesicles.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not applicable
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    First + second Groups
    Reporting group description
    		 Throughout the whole study, 16 patients out of 54 included patients (72%) experienced at least one adverse event suspected to be related to the test product and associated products and reported a total of 30 AEs. Serious adverse events (SAE) were not reported during this study.

    Serious adverse events
    		 First + second Groups
    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: 5%
    Non-serious adverse events
    		 First + second Groups
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 54 (29.63%)
    Skin and subcutaneous tissue disorders
    Burning sensation
    Additional description: Burning sensation on application
         subjects affected / exposed
    10 / 54 (18.52%)
         occurrences all number
    21
    Exacerbation of Atopic Dermatitis
         subjects affected / exposed
    4 / 54 (7.41%)
         occurrences all number
    5
    Pruritus
         subjects affected / exposed
    3 / 54 (5.56%)
         occurrences all number
    3
    Pruritus sensation erythema
         subjects affected / exposed
    1 / 54 (1.85%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Mar 2015
    Modification of study areas: Arms In order to facilitate recruitment without changing the target population, it has been decided to extend the target areas from the elbow creases to the arms (including wrists). Indeed, in adults, atopic Dermatitis (AD) often appears in the elbow creases, but lesions affect also forearms and wrists. Furthermore, in this study, each patient’s arm followed randomly a specific treatment regimen (either topical corticosteroids (TCS) alone, or association of TCS with RV4421A BS0042) and all scores (including primary criterion) were assessed independently on both sides. We considered that lesions on arms (including on wrists), similar in terms of extent and severity, didn't need to be symmetrical in terms of specific location on arms. For example, a patient could be included if he presented similar target lesions on the left wrist and the right elbow crease without impacting the study results. In order to have comparable data between all included patients, inclusion criteria related to disease severity were not modified. Popliteal fossa In order to make facilitate recruitment without changing the target population, it has been decided to extend the target areas not only on the arms, but also on the popliteal fossa. Popliteal fossa are areas commonly affected by inflammatory lesions in the adult population. Furthermore, AD often appears in these areas in a symmetrical distribution, perfectly adapted to an intra-individual study. According to several guidelines, moderately potent topical corticosteroids (TCS), like the one used in this study, are recommended for AD affecting the flexures. Both products are adapted to lesions affecting the popliteal fossa. We considered that a patient could be included if he presents similar lesions on the popliteal fossa without impacting the study results.

    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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