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    Clinical Trial Results:
    Open, Blindly Evaluated, Prospective, Controlled, Randomised, Multicentre Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 versus Standard of Care in Accelerating the Healing of Grade 2a Partial-Thickness Burn Wounds

    Summary
    EudraCT number
    2012-000362-38
    Trial protocol
    DE   SE   GB  
    Global end of trial date
    04 Jul 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Jun 2016
    First version publication date
    14 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BBW-11
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01657292
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Birken AG
    Sponsor organisation address
    Streiflingsweg 11, Niefern-Oeschelbronn, Germany, 75223
    Public contact
    Head of pharmaceutical development, Birken AG, T.Zahn@birken.eu
    Scientific contact
    Head of pharmaceutical development, Birken AG, T.Zahn@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
    07 Apr 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jul 2014
    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 with fatty gauze as wound dressing versus standard of care (defined as Octenilin wound gel) with fatty gauze as wound dressing in accelerating the healing of Grade 2a burns.
    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 Conference 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
    Fatty gauze wound dressing.
    Evidence for comparator
    Octenilin wound gel, an antiseptic octenidine formulated as hydrogel, was used as reference because it represents a standard of care for treating patients with burn injuries.
    Actual start date of recruitment
    31 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
    Sweden: 3
    Country: Number of subjects enrolled
    United Kingdom: 28
    Country: Number of subjects enrolled
    Germany: 31
    Country: Number of subjects enrolled
    Switzerland: 4
    Worldwide total number of subjects
    66
    EEA total number of subjects
    62
    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)
    60
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Study participants were enrolled from 31-Aug-2012 to 10-Jul-2013, in 10 clinical centres in 4 countries: Germany (4 centres), Uk (3 centres), Sweden (2 centres), and Switzerland (1 centre).

    Pre-assignment
    Screening details
    During screening the following was performed: check for inclusion/exclusion criteria, concomitant medication, pregnancy, demographics, medical history and signing informed consent form. 66 subjects were screened of which 5 violated eligibilty criteria and thus 61 subjects were treated.

    Pre-assignment period milestones
    Number of subjects started
    66
    Number of subjects completed
    61

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Violation of eligibility criteria: 4
    Reason: Number of subjects
    Language and social reasons: 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. Either 2 halves of 1 wound or 2 wounds of similar size and depth were used per subject. Treatment was assigned using a tamper-proof randomisation 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
    A suitable study wound was divided into 2 halves of equal size or 2 separate wounds of similar size and depth were used for evaluation. One randomly assigned wound or wound half was treated with Oleogel-S10 ointment and covered with fatty gauze.
    Arm type
    Experimental

    Investigational medicinal product name
    Oloegel-S10
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    1 cm of ointment string Oleogel-S10 (approximately 100 mg) per cm² of wound (i.e. approximately 1 mm thick), applied at every wound dressing change (latest every second day).

    Arm title
    Octenilin
    Arm description
    The other wound or wound half was treated with Octenilin wound gel and covered with fatty gauze.
    Arm type
    Active comparator

    Investigational medicinal product name
    Octenilin wound gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Administered at each wound dressing change (latest every second day).

    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 primarily based on blinded photo evaluation.
    Number of subjects in period 1
    Oleogel-S10 Octenilin
    Started
    61
    61
    Completed
    51
    51
    Not completed
    10
    10
         Consent withdrawn by subject
    2
    2
         Adverse event, non-fatal
    6
    6
         Violation of eligibility criteria
    1
    1
         Change of therapy
    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: Of the 66 subjects enrolled only wounds of 61 subjects were randomised and treated. Baseline characteristics are provided for these 61 subjects included in the safety and efficacy analyses.
    Reporting group values
    Treatment period Total
    Number of subjects
    61 61
    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)
    55 55
        From 65-84 years
    6 6
        85 years and over
    0 0
    Age continuous
    Units: years
        median (full range (min-max))
    41 (18 to 79) -
    Gender categorical
    Units: Subjects
        Female
    19 19
        Male
    42 42

    End points

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    End points reporting groups
    Reporting group title
    Oleogel-S10
    Reporting group description
    A suitable study wound was divided into 2 halves of equal size or 2 separate wounds of similar size and depth were used for evaluation. One randomly assigned wound or wound half was treated with Oleogel-S10 ointment and covered with fatty gauze.

    Reporting group title
    Octenilin
    Reporting group description
    The other wound or wound half was treated with Octenilin wound gel and covered with fatty gauze.

    Subject analysis set title
    ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The ITT analysis set included all subjects who were treated at least once, i.e. who received any dose of Oleogel-S10 or Octenilin wound gel. If the application of any study medication was not certain, the subjects was included in the ITT analysis set. Patients whose wound halves were not treated with the intended (i.e. randomised) treatment regimen were excluded from the ITT analysis set.

    Primary: Percentage of patients with earlier healing (at least 95% epithelialisation) of the wound half treated with Oloegel-S10 compared to standard of care (Octenilin wound gel), as evaluated by the majority decision of 3 independent, blinded experts

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    End point title
    Percentage of patients with earlier healing (at least 95% epithelialisation) of the wound half treated with Oloegel-S10 compared to standard of care (Octenilin wound gel), as evaluated by the majority decision of 3 independent, blinded experts
    End point description
    The blinded experts indicated for each subject whether the wounds or wound halves showed differences in time to wound closure (at least 95% epithelialisation) and, if such a difference was observed, which wound half healed faster. The majority decision of the 3 readers was used for evaluation.
    End point type
    Primary
    End point timeframe
    Photo acquired at every wound dressing change (at least every second day until full wound closure was achieved. At maximum Day 21 if wound closure was not achieved before).
    End point values
    Oleogel-S10 Octenilin
    Number of subjects analysed
    57
    57
    Units: Wounds
        Wounds with difference in healing
    35
    35
        Wounds with earlier healing
    30
    5
    Statistical analysis title
    Primary analysis
    Statistical analysis description
    The following hypotheses were tested: H0: s0 ≤0.5 and H1: s0 >0.5 (with s0=rate of superiority of Oleogel-S10) using a 1-sided, exact binomial test with a significance level of 0.025. A total of 57 subjects were included in the analysis (intra-individual comparison). Earlier healing was shown for Oleogel-S10 treated vs Octenilin treated wound halves in 30 subjects (85.7%). Earlier healing of the Octenilin treated vs the Oleogel-S10 treated wound halves was observed in 5 subjects (14.3%).
    Comparison groups
    Oleogel-S10 v Octenilin
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [1]
    Method
    Exact binomial test
    Confidence interval
    Notes
    [1] - Based on 1-sided, exact binomial test evaluating the rate of superiority of Oleogel-S10 being >0.5. The analysis is based only on the 35 subjects for whom a difference in healing was noted.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0 (start of treatment) till end of treatment (Day 21 or earlier if full wound closure was achieved earlier, or later, if the investigator decided to change medication and/or treatment due to unsatisfying wound closure after Day 21).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Safety analysis set
    Reporting group description
    The SAF included all subjects who were treated at least once, i.e. who received any dose of Oleogel-S10 or Octenilin wound gel.

    Serious adverse events
    Safety analysis set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 61 (13.11%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tonsil cancer
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Wound necrosis
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Soft tissue infection
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 2
         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
    13 / 61 (21.31%)
    Injury, poisoning and procedural complications
    Inflammation of wound
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Wound complication
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pain of skin
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    4
    Pruritus
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    Purpura
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Rash pruritic
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Infections and infestations
    Cystitis
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Wound infection
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2

    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
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