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    Clinical Trial Results:
    A randomised, intra-individual controlled trial of the cutaneous healing properties of petrolatum versus the vehicle for Oleogel-S10 when applied topically to mechanically induced partial thickness wounds in healthy volunteers

    Summary
    EudraCT number
    		 2020-002358-26
    Trial protocol
    		 DE  
    Global end of trial date
    16 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jun 2022
    First version publication date
    10 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AHV-18-B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amryt Research Ltd
    Sponsor organisation address
    45 Mespil Road, Dublin 4, Ireland,
    Public contact
    Head of Clinical Development, Amryt Research Ltd., 353 15180200, janet.boylan@amrytpharma.com
    Scientific contact
    Head of Clinical Development, Amryt Research Ltd., 353 15180200, janet.boylan@amrytpharma.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
    28 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jun 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the vehicle for Oleogel-S10 is non-inferior to petrolatum with regards to time to achieve cutaneous healing of mechanically induced partial thickness wounds in healthy volunteers
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles derived from the principles of Good Clinical Practices (GCP) and the declaration of Helsinki (1964) including all amendments up to the October 2013 revision. All local regulatory requirements pertinent to the safety of trial subjects were followed during the conduct of the trial. Patients attended daily throughout the trial and adverse events were monitored throughout the study.
    Background therapy
    		 None
    Evidence for comparator
    		 Topically applied leave-on products may be helpful to enhance cutaneous healing and re-epithelization of cutaneous wounds. An occlusive and ‘protective’ effect seems to be responsible for this phenomenon, but the performance of products depends on the overall composition and possible active ingredients. Amryt Pharma developed a vehicle of Oleogel-S10 to be used in a clinical phase III study comparing the efficacy of Oleogel-S10 to vehicle for the treatment of Epidermolysis bullosa (EB). Petrolatum is considered an example of a standard topical product to promote cutaneous healing in the management of wounds caused by EB. It is expected that the vehicle gel, that has been developed for use as a blinded comparator in the EB study, has similar beneficial effects on wound healing to those associated with the use of petrolatum.
    Actual start date of recruitment
    12 Apr 2021
    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: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    16
    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)
    16
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult healthy volunteers (n = 8 male, n = 8 female) were enrolled in the trial at the Clinical Research Center for Hair and Skin Science (CRC), Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Germany. The first patient fist visit was 12-Apr-2021 and the last patient last visit was 16-Jun-2021.

    Pre-assignment
    Screening details
    		 Subjects underwent assessments to determine eligibility at the Initial Screening Visit (Day-14 to Day-3). A total of 16 subjects entered the screening phase and all of them proceeded to the recruitment.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Data analyst, Assessor [2]
    Blinding implementation details
    The study was outcome-assessor blinded. Study personnel who administered the intervention and the subjects who received the interventions were not blinded. The Investigators who performed the wound assessments and standardised image analysis were blinded to treatment. To maintain the blind, the data manager, project manager and those preparing the analysis and results (programmers and statisticians) were blinded throughout the study until after database lock.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Control Gel
    Arm description
    		 Treatment with Control Gel
    Arm type
    		 Experimental

    Investigational medicinal product name
    Control Gel
    Investigational medicinal product code
    Other name
    Vehicle for Oleogel-S10
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Applied topically once daily for 16 days at a thickness of approximately 1 mm (0.04 inch) over the wound area (diameter 8 mm to cover the wound edges). The treated areas were covered with a non-adhesive wound dressing with a non-adherent pad (Mepitel® Border Lite) from Day 1 through Day 10 immediately after product application.

    Arm title
    		 Petrolatum (ALLERGIKA® – BASISSALBE)
    Arm description
    		 Treatment with Petrolatum (ALLERGIKA® – BASISSALBE)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Petrolatum (ALLERGIKA® – BASISSALBE)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Applied topically once daily for 16 days at a thickness of approximately 1 mm (0.04 inch) over the wound area (diameter 8 mm to cover the wound edges). The treated areas were covered with a non-adhesive wound dressing with a non-adherent pad (Mepitel® Border Lite) from Day 1 through Day 10 immediately after product application.

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: The study was outcome-assessor blinded. Study personnel who administered the intervention and the subjects who received the interventions were not blinded. The Investigators who performed the wound assessments and standardised image analysis were blinded to treatment. To maintain the blind, the data manager, project manager and those preparing the analysis and results (programmers and statisticians) were blinded throughout the study until after database lock.
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The study was outcome-assessor blinded. Study personnel who administered the intervention and the subjects who received the interventions were not blinded. The Investigators who performed the wound assessments and standardised image analysis were blinded to treatment. To maintain the blind, the data manager, project manager and those preparing the analysis and results (programmers and statisticians) were blinded throughout the study until after database lock.
    Number of subjects in period 1
    		Control Gel Petrolatum (ALLERGIKA® – BASISSALBE)
    Started
    16
    16
    Completed
    16
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control Gel
    Reporting group description
    		 Treatment with Control Gel

    Reporting group title
    Petrolatum (ALLERGIKA® – BASISSALBE)
    Reporting group description
    		 Treatment with Petrolatum (ALLERGIKA® – BASISSALBE)

    Reporting group values
    		 Control Gel Petrolatum (ALLERGIKA® – BASISSALBE) Total
    Number of subjects
    		 16 16 16
    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)
    		 16 16 16
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 8 8 8
        Male
    		 8 8 8

    End points

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    End points reporting groups
    Reporting group title
    Control Gel
    Reporting group description
    		 Treatment with Control Gel

    Reporting group title
    Petrolatum (ALLERGIKA® – BASISSALBE)
    Reporting group description
    		 Treatment with Petrolatum (ALLERGIKA® – BASISSALBE)

    Primary: Days until complete healing of mechanically induced wounds assessed by clinical score

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    End point title
    		 Days until complete healing of mechanically induced wounds assessed by clinical score
    End point description
    Days until complete healing of mechanically induced wounds assessed by clinical score
    End point type
    Primary
    End point timeframe
    Wound healing was assessed by clinical score from Day 1 through Day 16 and at the End of Study Visit.
    End point values
    		 Control Gel Petrolatum (ALLERGIKA® – BASISSALBE)
    Number of subjects analysed
    16
    16
    Units: days
        arithmetic mean (confidence interval 95%)
    14.19 (12.14 to 16.24)
    12.50 (11.57 to 13.43)
    Statistical analysis title
    		 Non-inferiority analysis
    Statistical analysis description
    The null hypothesis was that the control gel was inferior to petrolatum (i.e., H0: Mean difference ≥ NIM) and the alternative hypothesis was that the control gel was non-inferior to petrolatum (i.e., H1: Mean difference < NIM), where NIM was the non-inferiority margin which was equal to 1 day, and the difference corresponded to: Control gel - petrolatum.
    Comparison groups
    Control Gel v Petrolatum (ALLERGIKA® – BASISSALBE)
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.7925 [1]
    Method
    		 t-test, 1-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.69
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 3.44
    Variability estimate
    Standard deviation
    Dispersion value
    3.281
    Notes
    [1] - A paired T-Test was fitted to days until complete healing with one-sided alpha of 0.025.

    Secondary: Days until complete healing of mechanically induced wounds assessed by planimetry

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    End point title
    		 Days until complete healing of mechanically induced wounds assessed by planimetry
    End point description
    Planimetry was performed by computerised image analysis using the software ImageJ. The wound area was reported in mm2 and the means of the 2 independent measurements were used. Complete wound healing was defined as a mean wound area of 0 mm2.
    End point type
    Secondary
    End point timeframe
    Wound healing was assessed by planimetry on Day 1, Day 3, and Day 5 through Day 16.
    End point values
    		 Control Gel Petrolatum (ALLERGIKA® – BASISSALBE)
    Number of subjects analysed
    16
    16
    Units: days
        arithmetic mean (confidence interval 95%)
    8.56 (7.84 to 9.29)
    8.88 (8.40 to 9.35)
    Statistical analysis title
    		 Non-inferiority analysis
    Statistical analysis description
    The null hypothesis was that the control gel was inferior to petrolatum (i.e., H0: Mean difference ≥ NIM) and the alternative hypothesis was that the control gel was non-inferior to petrolatum (i.e., H1: Mean difference < NIM), where NIM was the non-inferiority margin which was equal to 1 day, and the difference corresponded to: Control gel - petrolatum.
    Comparison groups
    Control Gel v Petrolatum (ALLERGIKA® – BASISSALBE)
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0004 [2]
    Method
    		 t-test, 1-sided
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.31
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 0.35
    Variability estimate
    Standard deviation
    Dispersion value
    1.25
    Notes
    [2] - A paired T-Test was fitted to days until complete healing with one-sided alpha of 0.025.

    Secondary: Clinical score per day

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    End point title
    		 Clinical score per day
    End point description
    A 6-category clinical score was used to assess the degree of epithelialisation (0=0% [no healing], 1=1 to 25% re-epithelialisation, 2=26 to 50% re-epithelialisation, 3=51 to 75% re-epithelialisation, 4=>75% re-epithelialisation, but not complete healing, 5=100% re-epithelialisation [complete healing]).
    End point type
    Secondary
    End point timeframe
    Wound healing was assessed by clinical score from Day 1 through Day 16 and at the End of Study Visit.
    End point values
    		 Control Gel Petrolatum (ALLERGIKA® – BASISSALBE)
    Number of subjects analysed
    16
    16
    Units: Clinical score per day
    median (full range (min-max))
        Day 1
    0 (0 to 0)
    0 (0 to 0)
        Day 2
    0 (0 to 1.0)
    0 (0 to 1.0)
        Day 3
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        Day 4
    1.0 (1.0 to 2.0)
    1.0 (1.0 to 2.0)
        Day 5
    2.0 (1.0 to 4.0)
    1.0 (1.0 to 2.0)
        Day 6
    2.0 (1.0 to 3.0)
    2.0 (1.0 to 3.0)
        Day 7
    3.0 (2.0 to 4.0)
    3.0 (2.0 to 3.0)
        Day 8
    3.0 (2.0 to 4.0)
    3.0 (2.0 to 4.0)
        Day 9
    4.0 (3.0 to 5.0)
    4.0 (2.0 to 4.0)
        Day 10
    4.0 (3.0 to 5.0)
    4.0 (3.0 to 5.0)
        Day 11
    4.0 (3.0 to 5.0)
    4.0 (3.0 to 5.0)
        Day 12
    4.0 (3.0 to 5.0)
    5.0 (4.0 to 5.0)
        Day 13
    4.0 (4.0 to 5.0)
    5.0 (4.0 to 5.0)
        Day 14
    5.0 (4.0 to 5.0)
    5.0 (4.0 to 5.0)
        Day 15
    5.0 (4.0 to 5.0)
    5.0 (4.0 to 5.0)
        Day 16
    5.0 (4.0 to 5.0)
    5.0 (5.0 to 5.0)
        End of Study Visit
    5.0 (5.0 to 5.0)
    5.0 (5.0 to 5.0)
    No statistical analyses for this end point

    Secondary: Wound surface area in mm2 per day (assessed by planimetry)

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    End point title
    		 Wound surface area in mm2 per day (assessed by planimetry)
    End point description
    Wound surface area in mm2 per day (assessed by planimetry)
    End point type
    Secondary
    End point timeframe
    Wound healing was assessed by planimetry on Day 1, Day 3, and Day 5 through Day 16.
    End point values
    		 Control Gel Petrolatum (ALLERGIKA® – BASISSALBE)
    Number of subjects analysed
    16
    16
    Units: mm2
    arithmetic mean (standard deviation)
        Day 1
    42.97 ± 9.011
    42.15 ± 9.584
        Day 3
    33.04 ± 9.221
    33.82 ± 7.454
        Day 5
    17.47 ± 7.342
    19.39 ± 7.035
        Day 6
    7.98 ± 4.285
    11.37 ± 3.919
        Day 7
    2.71 ± 2.035
    5.27 ± 3.489
        Day 8
    0.87 ± 1.160
    1.61 ± 2.085
        Day 9
    0.40 ± 1.016
    0.25 ± 0.661
        Day 10
    0.02 ± 0.085
    0.07 ± 0.267
        Day 11
    0.00 ± 0.000
    0.00 ± 0.000
        Day 12
    0.00 ± 0.000
    0.00 ± 0.000
        Day 13
    0.00 ± 0.000
    0.00 ± 0.000
        Day 14
    0.00 ± 0.000
    0.00 ± 0.000
        Day 15
    0.00 ± 0.000
    0.00 ± 0.000
        Day 16
    0.00 ± 0.000
    0.00 ± 0.000
    No statistical analyses for this end point

    Secondary: Adverse Events

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    End point title
    		 Adverse Events
    End point description
    Incidence, severity, and causality of local tolerance AEs, and incidence, severity, and causality of all AEs.
    End point type
    Secondary
    End point timeframe
    AEs were monitored throughout the study from the time of informed consent through Day 23±2 days.
    End point values
    		 Control Gel Petrolatum (ALLERGIKA® – BASISSALBE)
    Number of subjects analysed
    16
    16
    Units: Adverse Events
    number (not applicable)
        Application site pain
    1
    0
        Application site pruritus
    1
    0
        Application site erosion
    4
    0
        Ligament sprain
    1
    1
        Nasopharyngitis
    1
    1
        Rhinitis allergic
    1
    1
        Pruritus
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were monitored throughout the study from the time of informed consent through Day 23±2 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Control Gel
    Reporting group description
    		 Treatment with Control Gel

    Reporting group title
    Petrolatum (ALLERGIKA® – BASISSALBE)
    Reporting group description
    		 Treatment with Petrolatum (ALLERGIKA® – BASISSALBE)

    Reporting group title
    Not applicable
    Reporting group description
    		 AEs not associated with any of the IMPs.

    Serious adverse events
    		 Control Gel Petrolatum (ALLERGIKA® – BASISSALBE) Not applicable
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
    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
    		 Control Gel Petrolatum (ALLERGIKA® – BASISSALBE) Not applicable
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 16 (0.00%)
    3 / 16 (18.75%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Application site pruritus
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    Application site erosion
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    4
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Sep 2020
    Protocol Amendment 1 Changes in this amendment included: - Inclusion of SARS-CoV-2 screening at the screening visit - Details relating to termination of the study added
    28 Apr 2021
    Protocol Amendment 2 Changes in this amendment included: - a shelf life extension due to updated stability data - a change of the sponsor’s address - updated estimated timelines in the protocol and - various further minor updates to the IMPD.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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