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    Clinical Trial Results:
    A Phase II Randomized, Controlled Parallel-Group Pilot Study to Assess the Safety and Efficacy of Kék Lukács Ointment Compared to Standard Silver Sulphadiazine (Dermazin®, SSD) Therapy in the Wound-healing of Patients With Deep Partial Thickness (Second-Degree) Burns

    Summary
    EudraCT number
    		 2011-005037-39
    Trial protocol
    		 HU  
    Global end of trial date
    12 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Oct 2021
    First version publication date
    20 Oct 2021
    Other versions
    Summary report(s)
    		 Report Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    KEKLUKACS-CLIN-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Kék-Lukács Kft.
    Sponsor organisation address
    Mártírok street 53, Iharosberény, Hungary, 8725
    Public contact
    KÉKLUKÁCS Help Desk, AdWare Research Ltd.‎, 36 87789073, info@adwareresearch.com
    Scientific contact
    KÉKLUKÁCS Help Desk, AdWare Research Ltd.‎, 36 87789073, info@adwareresearch.com
    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
    12 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the clinical efficacy of Kék Lukács ointment treatment with standard silver sulphadiazine (SSD) therapy in wound healing; degree of epithelisation of wound until Day 22 of treatment compared to Day 1.
    Protection of trial subjects
    Wound pain management
    Background therapy
    		 Only physical bound care management was applied.
    Evidence for comparator
    		 Standard Silver Sulphadiazine (Dermazin®, SSD) therapeuthic product was applied as a same therapeutic indication for approved standard treatment.
    Actual start date of recruitment
    12 Sep 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
    Hungary: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    21
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patient recruitment took place in Hungary in 2012

    Pre-assignment
    Screening details
    		 The total number of 44 patient was expected to enrolled to the study, 20 evaluable subjects per group were needed. 20 g/200 cm2 ointment was applied in the case of the active group and the control group got 10-20 g/200 cm2 Dermazin cream. Inclusion and exclusion criteria were defined in the final study protocol.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Kék Lukács ointment group received 20 g/200 cm2 once daily for maximum 21 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Kék Lukács ointment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Skin scarification
    Dosage and administration details
    The ointment should be applied to a thickness between 1-2 mm onto the sterile gauze before covering the burned surface once daily for maximum 21 days, dose 20 g/200 cm2

    Arm title
    		 Placebo
    Arm description
    		 Silver Sulphadiazine (SSD, Dermazin®)) cream group received 10-20 g/200 cm2 once daily for maximum 21 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dermazin®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Skin scarification
    Dosage and administration details
    The cream should be applied to a thickness between 2-4 mm onto the gauze before covering the burned surface once daily for maximum 21 days, dose 10-20 g/200 cm2

    Number of subjects in period 1
    		Active Placebo
    Started
    10
    12
    Completed
    10
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 22 22
    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)
    		 21 21
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 13 13
    Subject analysis sets

    Subject analysis set title
    Safety analysis set:
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects randomized and receiving at least one treatment are included in the safety analysis set.

    Subject analysis set title
    Intent-to-treat analysis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects randomized, receiving at least one treatment and having at least one post-baseline evaluation of the wound healing area included in the intent to-treat analysis set.

    Subject analysis set title
    Per protocol analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects randomized, receiving at least one treatment and having at least one post-baseline evaluation of the wound healing area, and having no major protocol deviations are included in the per protocol analysis set.

    Subject analysis sets values
    		 Safety analysis set: Intent-to-treat analysis set Per protocol analysis set
    Number of subjects
    22
    21
    21
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    21
    20
    20
        From 65-84 years
    1
    1
    1
        85 years and over
    0
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    9
    9
    9
        Male
    13
    12
    12

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Kék Lukács ointment group received 20 g/200 cm2 once daily for maximum 21 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Silver Sulphadiazine (SSD, Dermazin®)) cream group received 10-20 g/200 cm2 once daily for maximum 21 days.

    Subject analysis set title
    Safety analysis set:
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    All subjects randomized and receiving at least one treatment are included in the safety analysis set.

    Subject analysis set title
    Intent-to-treat analysis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects randomized, receiving at least one treatment and having at least one post-baseline evaluation of the wound healing area included in the intent to-treat analysis set.

    Subject analysis set title
    Per protocol analysis set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects randomized, receiving at least one treatment and having at least one post-baseline evaluation of the wound healing area, and having no major protocol deviations are included in the per protocol analysis set.

    Primary: Reduction in wound surface area

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    End point title
    		 Reduction in wound surface area
    End point description
    The study was stopped earlier because of the slow patient recruitment. However, planned analysis was performed with the available (smaller) sample size. The aims of this analysis were:  to appropriately perform analyses described by the study protocol,  obtain relevant pharmacokinetic information and  confirm the sample size calculation of the following clinical study of Kek Lukacs ointment
    End point type
    Primary
    End point timeframe
    Day 1 to Day 22 (3 weeks after treatment start)
    End point values
    		 Active Placebo Per protocol analysis set
    Number of subjects analysed
    10
    11
    21
    Units: percent
    10
    11
    21
    Statistical analysis title
    		 random coefficient model
    Comparison groups
    Active v Placebo v Per protocol analysis set
    Number of subjects included in analysis
    42
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5645 [1]
    Method
    		 random coefficient model
    Confidence interval
    Notes
    [1] - For treatment is 0.6346, for Day p-value is less than 0.0001. Descriptive Statistics are also provided in the report.

    Secondary: Incidence of complete wound healing full epithelisation within 22 days

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    End point title
    		 Incidence of complete wound healing full epithelisation within 22 days
    End point description
    The scores assigned by the Investigator to the signs of wound infection and inflammation were compared across the two treatment groups by a Wilcoxon–Mann–Whitney test, for each timepoint separately
    End point type
    Secondary
    End point timeframe
    within 22 days for each timepoint
    End point values
    		 Active Placebo Intent-to-treat analysis set
    Number of subjects analysed
    10
    11
    21
    Units: frequency
    10
    11
    21
    No statistical analyses for this end point

    Secondary: Percent reduction of wound surface area, on Day 8, 15 and 22 from Day 1

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    End point title
    		 Percent reduction of wound surface area, on Day 8, 15 and 22 from Day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Day 8, 15 and 22 from Day 1
    End point values
    		 Active Placebo Intent-to-treat analysis set
    Number of subjects analysed
    10
    11
    Units: Percent
    10
    11
    21
    No statistical analyses for this end point

    Other pre-specified: Incidence of treatment- related adverse events during the whole study period.

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    End point title
    		 Incidence of treatment- related adverse events during the whole study period.
    End point description
    End point type
    Other pre-specified
    End point timeframe
    from the sign of the informed consent to the end of the study
    End point values
    		 Active Placebo Intent-to-treat analysis set
    Number of subjects analysed
    10
    11
    21
    Units: frequency
    10
    11
    21
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From 2012.09.12. to 2013.09.19.
    Adverse event reporting additional description
    25 adverse events were reported during the study. Relationship between the treatment and the adverse event was examined. Adverse events were presented in summary tables by severity, outcome and relation to the study and tabulated by the action taken in relation to the study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Severity
    Reporting group description
    		 Adverse events were presented by severity: mild, moderate and severe events were determined.

    Serious adverse events
    		 Severity
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 22 (4.55%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Skin and subcutaneous tissue disorders
    Hospitalization due to necrectomia and skin-grafting
         subjects affected / exposed
    1 / 22 (4.55%)
         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
    		 Severity
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 22 (45.45%)
    Injury, poisoning and procedural complications
    all burned wounds have pain
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    General disorders and administration site conditions
    shivering-fit
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    leg pain
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Elevated ASO
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    leg oedema
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Immune system disorders
    allergy to dog fur
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    targeted wound pain
         subjects affected / exposed
    5 / 22 (22.73%)
         occurrences all number
    7
    Infections and infestations
    fever
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    4
    Pharyngitis
         subjects affected / exposed
    1 / 22 (4.55%)
         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
    28 Oct 2012
    The number of the sites, the post-burn status, the leaflet (number of sites, post-burn status were changed and reimbursement fee were included) were changed. Urine pregnancy test for female patients with childbearing potential was needed.

    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.
    Planned analysis was performed with the available (smaller) sample size, because of the slow patient enrollment.
    For support, Contact us.
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