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    Clinical Trial Results:
    Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 versus Standard of Care in Accelerating the Wound Healing of Split-Thickness Skin Graft Donor Sites

    Summary
    EudraCT number
    2012-000777-23
    Trial protocol
    DE   CZ   FI   AT   BG   PL  
    Global end of trial date
    23 Aug 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BSH-12
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01657305
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Birken AG
    Sponsor organisation address
    Streiflingsweg 11, Niefern-Oeschelbronn, Germany, 75223
    Public contact
    Pharmaceutical Development, Birken AG, +49 723397490, info@birken.eu
    Scientific contact
    Pharmaceutical Development, Birken AG, +49 723397490, info@birken.eu
    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
    10 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare intra-individually the efficacy and tolerance of Oleogel-S10 versus non-adhesive wound dressing alone in accelerating the wound healing of Split-Thickness Skin Graft Donor Sites (STSG).
    Protection of trial subjects
    The study was conducted in compliance with the study protocol, ethical principles originating in or derived from the Declaration of Helsinki, ethics committee informed consent regulations, and International Council on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. In addition, all national and local regulatory requirements were followed. Insurance coverage for all participating subjects was guaranteed according to applicable legal requirements. Before undergoing any study-specific procedures, subjects were informed about the nature, scope, and possible consequences of the study. The investigator was responsible for obtaining a subject's written informed consent to participate in the study.
    Background therapy
    Non-adhesive wound-dressing.
    Evidence for comparator
    Non-adhesive wound dressing represents a standard of care for patients with STSG donor sites.
    Actual start date of recruitment
    03 Aug 2012
    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
    Poland: 2
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    Bulgaria: 24
    Country: Number of subjects enrolled
    Czech Republic: 40
    Country: Number of subjects enrolled
    Finland: 3
    Country: Number of subjects enrolled
    Germany: 38
    Worldwide total number of subjects
    111
    EEA total number of subjects
    111
    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)
    69
    From 65 to 84 years
    39
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    Study participants were enrolled from 03-Aug-2012 to 25-Jul-2013 at 18 clinical centres in 6 countries: Germany (8 centres), Czech Republic (2 centres), Poland (1 centre), Finland (1 centre), Austria (2 centres), Bulgaria (4 centres).

    Pre-assignment
    Screening details
    During screening the following was performed: informed consent, demographics, medical history, prior medication, and prenancy test. On day of surgery the inclusion/exclusion criteria were checked. 111 subjects were screened and enrolled, but only 107 subjects were treated as indicated below.

    Pre-assignment period milestones
    Number of subjects started
    111
    Number of subjects completed
    107

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Consent withdrawn by subject: 1
    Reason: Number of subjects
    Not randomised by mistake: 1
    Reason: Number of subjects
    Violation of inclusion criterion no. 2: 1
    Reason: Number of subjects
    STSG surgery was cancelled: 1
    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Assessor [1]
    Blinding implementation details
    Treatments were intra-individually compared. The STSG donor site was divided into two areas of equal size. Since the distance of the wounds from the centre of the body might influence the wound healing process, the wound halves were randomly assigned to treatment by a temper-proof method. Treatment was open to study subjects and investigators, but assessment of efficacy was primarily based on blinded photo evaluation. Special care was taken to ensure blinding, i.e. all markings were removed.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Oleogel-S10
    Arm description
    One half of the study wound was treated with Oleogel-S10 plus non-adhesive dressing.
    Arm type
    Experimental

    Investigational medicinal product name
    Oleogel-S10
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    About 1 cm Oleogel-S10 ointment (approximately 100 mg) per cm² (i.e. approximately 1 mm thick) was applied at every wound dressing change (every 3 to 4 days) to one half of the STSG donor site by applying it onto the wound-facing side of the wound dressing.

    Arm title
    Standard of care
    Arm description
    One half of the study wound was treated according to standard of care by applying a non-adhesive dressing.
    Arm type
    Non-active comparator

    Investigational medicinal product name
    Non-adhesive dressing
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Topical use
    Dosage and administration details
    The dressing was changed every 3 to 4 days.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Treatment was open to study subjects and investigators, but assessment of efficacy was performed by assessors based on blinded photo evaluation.
    Number of subjects in period 1
    Oleogel-S10 Standard of care
    Started
    107
    107
    Completed
    82
    82
    Not completed
    25
    25
         Consent withdrawn by subject
    4
    4
         Adverse event, non-fatal
    1
    1
         No full wound closure achieved at Day 28
    15
    15
         Not adhering to study rules and procedures
    4
    4
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Treatment period
    Reporting group description
    -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 107 patients were randomised to the study and received at least one dose of treatment.
    Reporting group values
    Treatment period Total
    Number of subjects
    107 107
    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)
    67 67
        From 65-84 years
    38 38
        85 years and over
    2 2
    Age continuous
    Units: years
        median (full range (min-max))
    56 (18 to 86) -
    Gender categorical
    Units: Subjects
        Female
    39 39
        Male
    68 68

    End points

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    End points reporting groups
    Reporting group title
    Oleogel-S10
    Reporting group description
    One half of the study wound was treated with Oleogel-S10 plus non-adhesive dressing.

    Reporting group title
    Standard of care
    Reporting group description
    One half of the study wound was treated according to standard of care by applying a non-adhesive dressing.

    Primary: Intra-individual difference in time to wound closure

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    End point title
    Intra-individual difference in time to wound closure
    End point description
    The primary endpoint of this study was the intra-individual difference in time to wound closure (defined as at least 95% epithelialization) between wound halves either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing alone, based on blinded photo evaluation by three independent, blinded experts.
    End point type
    Primary
    End point timeframe
    Within 28 days after start of treatment (Day 0 - Day 28). Photos were aquired at every wound dressing change every 3 to 4 days.
    End point values
    Oleogel-S10 Standard of care
    Number of subjects analysed
    107
    107
    Units: Day
        arithmetic mean (confidence interval 95%)
    -1.4 (-1.8 to -0.9)
    0 (0 to 0)
    Statistical analysis title
    Primary analysis
    Statistical analysis description
    The difference in time to wound closure was tested using a two-sided paired t-test. The test was performed at a significance level of 5% for the null-hypothesis of no difference δ = 0 against the hypotheses δ ≠ 0: H0: δ = 0 H1: δ ≠ 0
    Comparison groups
    Oleogel-S10 v Standard of care
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    < 0.0001 [2]
    Method
    Two-sided paired t-test
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.8
         upper limit
    -0.9
    Variability estimate
    Standard deviation
    Dispersion value
    2.3
    Notes
    [1] - Difference in time to wound closure was calculated by comparing wound closure times of corresponding wound halves per patient followed by calculation of the mean of the expert-specific differences for each patient. The primary endpoint was then derived from the mean values for all subjects. If wound closure was not observed in a wound half (2 subjects), specific assumption were made to calculate the difference e.g. wound closure later than the last photo or, intra-individual difference is 0.
    [2] - The p-value indicated above is valid for the intra-individual comparison of time to wound healing between the 2 wounds halves for the Intention-To-Treat analysis set (107 subjects).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded from start of study treatment to completion of study treatment.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Safety analysis set
    Reporting group description
    The safety analysis set (SAF) included all patients who received treatment at least once, i.e. who received any dose of Oleogel S10 or non-adhesive wound dressing. If the application of any treatment was uncertain, the patient was included in the SAF.

    Serious adverse events
    Safety analysis set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 107 (1.87%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Wound infection
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Safety analysis set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 107 (16.82%)
    Investigations
    Oxygen saturation increased
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic malignant melanoma
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Procedural complication
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences all number
    1
    Wound haemorrhage
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences all number
    1
    General disorders and administration site conditions
    Impaired healing
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 107 (1.87%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Pain of skin
         subjects affected / exposed
    2 / 107 (1.87%)
         occurrences all number
    2
    Pruritus
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences all number
    1
    Infections and infestations
    Gastrointestinal infection
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences all number
    1
    Skin infection
         subjects affected / exposed
    4 / 107 (3.74%)
         occurrences all number
    4
    Urethritis
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences all number
    1
    Wound infection
         subjects affected / exposed
    2 / 107 (1.87%)
         occurrences all number
    2
    Wound infection staphylococcal
         subjects affected / exposed
    1 / 107 (0.93%)
         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
    09 May 2012
    • Inclusion criterion 5 (women of childbearing potential were to apply effective method of birth control) was added; • Exclusion criterion 6 (pregnant and breast fe4eding women were excluded) was added; • Pregnancy test was added as a task to be performed at Screening.
    29 Jan 2013
    • Frequency of dress changes was reduced from every two to three days to every three to four days • Planned patient number was reduced from 130 to 105 patients • Inclusion criterion 2 was changed to reduce the size of the wound area from 20 cm² to 15 cm²

    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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