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    Clinical Trial Results:
    Clinical trial on skin care in Neonatology. A comparison between two skin care products and no skin care

    Summary
    EudraCT number
    		 2005-001269-32
    Trial protocol
    		 AT  
    Global end of trial date
    28 Feb 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Oct 2021
    First version publication date
    24 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    01/05
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52, Innsbruck, Austria, 6020
    Public contact
    Univ.Prof.Dr.Ursula Kiechl-Kohlendorfer, Medical University Innsbruck, Paediatrics II, Anichstrasse 35, 6020 Innsbruck , +43 (0) 512 50504-27309, ursula.kiechl-kohlendorfer@tirol-kliniken.at
    Scientific contact
    Univ.Prof.Dr.Ursula Kiechl-Kohlendorfer, Medical University Innsbruck, Paediatrics II, Anichstrasse 35, 6020 Innsbruck , +43 (0) 512 50504-27309, ursula.kiechl-kohlendorfer@tirol-kliniken.at
    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
    28 Feb 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Feb 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Feb 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Comparison of the effect of 2 skin care products and no skin care on the integrity and condition of skin in newborn infants.
    Protection of trial subjects
    Infants, who developed dermatitis were treated with standard of care topical skin therapy. These neonates were switched to a therapy regime with ultrasic ⁄ ultrabas.
    Background therapy
    		 Subjects received treatment of an intensive care unit.
    Evidence for comparator
    		 There was no evidence for a comparator.
    Actual start date of recruitment
    01 Oct 2004
    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
    Austria: 173
    Worldwide total number of subjects
    173
    EEA total number of subjects
    173
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    173
    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)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between October 2004 and November 2006, all infants between 25 and 36 weeks of gestation who were admitted to a neonatal intensive care unit (NICU) were prospectively enrolled.

    Pre-assignment
    Screening details
    		 Infants were excluded if survival was expected to be <48 hours, or if they had manifest skin disease or life-threatening congenital anomalies.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Once informed consent was obtained, neonates were randomly assigned to group A (Bepanthen®; Bayer Healthcare, Wuppertal, Germany), group B (olive oil cream), or group C (control).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bepanthen
    Arm description
    		 Skin therapy was applied twice a day. The body, except the face and scalp, was treated with a thin coat of the Bepanthen cream. In this treatment group, therapy commenced within the first 24 hours of life.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bepanthen Cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Topical emollient was dispensed to each neonate in tubes containing 10 g that contained enough emollient for 1 day. Each neonate was continuously treated for a maximum of 4 weeks. Infants who were transferred out of the NICU before day 28 were followed up on the intermediate care unit. Skin therapy was applied twice a day. The body, except the face and scalp, was treated with a thin coat of the Bepanthen cream.

    Arm title
    		 Olive Oil Cream
    Arm description
    		 Skin therapy was applied twice a day. The body, except the face and scalp, was treated with olive oil cream. In this treatment group, therapy commenced within the first 24 hours of life.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lanoline/ Olive Oil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    In the current study a mixture of 30% olive oil and 70% lanoline produced in our pharmacy was used. Each neonate was continuously treated for a maximum of 4 weeks. Infants who were transferred out of the NICU before day 28 were followed up on the intermediate care unit. Skin therapy was applied twice a day. The body, except the face and scalp, was treated with olive oil cream.

    Arm title
    		 Control
    Arm description
    		 The control group received routine skin care without topical emollients or other measures to prevent skin breakdown or modulate skin-barrier function.
    Arm type
    		 control

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Bepanthen Olive Oil Cream Control
    Started
    57
    58
    58
    Completed
    49
    47
    51
    Not completed
    8
    11
    7
         Adverse event, serious fatal
    1
    -
    -
         Discharge or transfer to a different hospital
    7
    11
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bepanthen
    Reporting group description
    		 Skin therapy was applied twice a day. The body, except the face and scalp, was treated with a thin coat of the Bepanthen cream. In this treatment group, therapy commenced within the first 24 hours of life.

    Reporting group title
    Olive Oil Cream
    Reporting group description
    		 Skin therapy was applied twice a day. The body, except the face and scalp, was treated with olive oil cream. In this treatment group, therapy commenced within the first 24 hours of life.

    Reporting group title
    Control
    Reporting group description
    		 The control group received routine skin care without topical emollients or other measures to prevent skin breakdown or modulate skin-barrier function.

    Reporting group values
    		 Bepanthen Olive Oil Cream Control Total
    Number of subjects
    		 57 58 58 173
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 57 58 58 173
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: weeks
        median (full range (min-max))
    		 30.3 (25 to 36) 30.4 (25 to 36) 30.5 (25 to 36) -
    Gender categorical
    Units: Subjects
        Female
    		 31 27 22 80
        Male
    		 26 31 36 93

    End points

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    End points reporting groups
    Reporting group title
    Bepanthen
    Reporting group description
    		 Skin therapy was applied twice a day. The body, except the face and scalp, was treated with a thin coat of the Bepanthen cream. In this treatment group, therapy commenced within the first 24 hours of life.

    Reporting group title
    Olive Oil Cream
    Reporting group description
    		 Skin therapy was applied twice a day. The body, except the face and scalp, was treated with olive oil cream. In this treatment group, therapy commenced within the first 24 hours of life.

    Reporting group title
    Control
    Reporting group description
    		 The control group received routine skin care without topical emollients or other measures to prevent skin breakdown or modulate skin-barrier function.

    Primary: Skin Condition Grading

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    End point title
    		 Skin Condition Grading
    End point description
    Skin condition was graded on a 4-point scale (1–4) modified from the one published by Lane and Drost with a score of one denoting the best condition and a score of 4 the worst. Grading considered skin dryness, presence of erythema, and skin breakdown.
    End point type
    Primary
    End point timeframe
    Day 0 - Day 28
    End point values
    		 Bepanthen Olive Oil Cream Control
    Number of subjects analysed
    57 [1]
    58 [2]
    58 [3]
    Units: Skin Condition Grading
    arithmetic mean (standard deviation)
        Day 0
    1.07 ( 0.29 )
    1.10 ( 0.31 )
    1.10 ( 0.31 )
        Day 7
    1.18 ( 0.43 )
    1.09 ( 0.28 )
    1.33 ( 0.74 )
        Day 14
    1.67 ( 0.81 )
    1.28 ( 0.56 )
    2.11 ( 1.04 )
        Day 21
    2.07 ( 1.15 )
    1.40 ( 0.79 )
    3.00 ( 1.05 )
        Day 28
    2.00 ( 1.09 )
    1.40 ( 0.81 )
    2.70 ( 1.03 )
    Notes
    [1] - Day 0:57 subjects; day 7:57 subjects; day 14:57 subjects; day 21:55 subjects; day 28:38 subjects
    [2] - Day 0:58 subjects; day 7:58 subjects; day 14:58 subjects; day 21:58 subjects; day 28:45 subjects
    [3] - Day 0:58 subjects; day 7:58 subjects; day 14:56 subjects; day 21:48 subjects; day 28:20 subjects
    Statistical analysis title
    		 Skin Condition Grading, Day 7
    Comparison groups
    Bepanthen v Olive Oil Cream v Control
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.042
    Method
    		 t-test, 2-sided
    Confidence interval
    Statistical analysis title
    		 Skin Condition Grading, Day 14
    Comparison groups
    Bepanthen v Olive Oil Cream v Control
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [4]
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [4] - At day 14, 171 subjects were analysed.
    Statistical analysis title
    		 Skin Condition Grading, Day 21
    Comparison groups
    Bepanthen v Olive Oil Cream v Control
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [5]
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [5] - At day 21, 161 subjects were analysed.
    Statistical analysis title
    		 Skin Condition Grading, Day 28
    Comparison groups
    Bepanthen v Olive Oil Cream v Control
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [6]
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [6] - At day 28, 103 subjects were analysed.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    October 2004 - November 2006
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Bepanthen
    Reporting group description
    		 Skin therapy was applied twice a day. The body, except the face and scalp, was treated with a thin coat of the Bepanthen cream. In this treatment group, therapy commenced within the first 24 hours of life.

    Reporting group title
    Olive oil cream
    Reporting group description
    		 Skin therapy was applied twice a day. The body, except the face and scalp, was treated with olive oil cream. In this treatment group, therapy commenced within the first 24 hours of life.

    Reporting group title
    Control
    Reporting group description
    		 The control group received routine skin care without topical emollients or other measures to prevent skin breakdown or modulate skin-barrier function.

    Serious adverse events
    		 Bepanthen Olive oil cream Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 58 (0.00%)
    0 / 58 (0.00%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Bepanthen Olive oil cream Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 57 (19.30%)
    2 / 58 (3.45%)
    31 / 58 (53.45%)
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    11 / 57 (19.30%)
    2 / 58 (3.45%)
    31 / 58 (53.45%)
         occurrences all number
    44
    44
    44

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/18429773
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