Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    An exploratory randomized, intra-individual controlled trial of the cutaneous healing properties of Petrolatum versus the vehicle for Oleogel-S10 versus no treatment when applied topically to mechanically induced partial thickness wounds in healthy volunteers

    Summary
    EudraCT number
    		 2019-002081-12
    Trial protocol
    		 DE  
    Global end of trial date
    04 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Jun 2021
    First version publication date
    10 Jun 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AHV-18-A
    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 Dublin2, Dublin 2, Ireland, D04 W2F1
    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
    04 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe and to measure cutaneous healing of mechanically induced wounds with application of vehicle of Oleogel-S10, petrolatum, and no treatment in healthy volunteers in a wound healing model of mechanically induced wounds.
    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
    23 Jan 2020
    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: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Adult healthy volunteers (n = 6 male, n = 6 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 23-Jan-2020 and the last patient last visit was 04-Mar-2020.

    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 for which 12 proceeded to the recruitment.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Study personnel who administered the intervention and the subjects who received the interventions were not blinded. The Investigators and study staff who performed the wound assessments were blinded to treatment.

    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 21 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®Film) 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 21 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®Film) from Day 1 through Day 10 immediately after product application.

    Arm title
    		 Untreated control
    Arm description
    		 No topical treatment applied. Covered with a non adhesive wound dressing with a non adherent pad (Mepitel®Film) from Day 1 through Day 10.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Control Gel Petrolatum (ALLERGIKA® – BASISSALBE) Untreated control
    Started
    12
    12
    12
    Completed
    11
    11
    11
    Not completed
    1
    1
    1
         Lost to follow-up
    1
    1
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall period
    Reporting group description
    		 -

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 12
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 6 6

    End points

    		 Close Top of page
    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)

    Reporting group title
    Untreated control
    Reporting group description
    		 No topical treatment applied. Covered with a non adhesive wound dressing with a non adherent pad (Mepitel®Film) from Day 1 through Day 10.

    Primary: Complete wound healing according to Clinical Score

    		 Close Top of page
    End point title
    		 Complete wound healing according to Clinical Score [1]
    End point description
    A six 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=Greater than 75% re epithelialisation, but not complete healing, 5=100% re epithelialisation [complete healing].
    End point type
    Primary
    End point timeframe
    Wound healing was assessed from Day 1 through Day 28.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this was an exploratory study, only descriptive statistical methods were applied. The investigational medicinal products (IMPs) and the untreated control were not compared using a statistical test; no null hypotheses were tested.
    End point values
    		 Control Gel Petrolatum (ALLERGIKA® – BASISSALBE) Untreated control
    Number of subjects analysed
    11
    11
    11
    Units: Days to complete wound healing
        number (confidence interval 95%)
    13.3 (12.3 to 14.2)
    13.4 (12.4 to 14.3)
    13.3 (12.3 to 14.3)
    No statistical analyses for this end point

    Primary: Complete wound healing according to Planimetry

    		 Close Top of page
    End point title
    		 Complete wound healing according to Planimetry [2]
    End point description
    Wound healing measurements (planimetry) were performed by computerised image analysis using the software ImageJ.
    End point type
    Primary
    End point timeframe
    Wound healing was assessed from Day 1 through Day 28.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this was an exploratory study, only descriptive statistical methods were applied. The investigational medicinal products (IMPs) and the untreated control were not compared using a statistical test; no null hypotheses were tested.
    End point values
    		 Control Gel Petrolatum (ALLERGIKA® – BASISSALBE) Untreated control
    Number of subjects analysed
    11
    11
    11
    Units: Days to complete wound healing
        number (confidence interval 95%)
    10.6 (9.8 to 11.4)
    10.5 (9.6 to 11.3)
    10.6 (9.5 to 11.8)
    No statistical analyses for this end point

    Secondary: Adverse Events

    		 Close Top of page
    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
    Adverse events (AEs) were monitored throughout the study from the time of informed consent through Day 28.
    End point values
    		 Control Gel Petrolatum (ALLERGIKA® – BASISSALBE) Untreated control
    Number of subjects analysed
    12
    12
    12
    Units: Adverse Events
        Medical device site papule
    7
    7
    7
        Application site papules
    4
    1
    2
        Medical device site pustule
    1
    1
    1
        Epistaxis
    1
    1
    1
        Nasopharyngitis
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Clinical Score Per Day

    		 Close Top of page
    End point title
    		 Clinical Score Per Day
    End point description
    A six 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=Greater than 75% re epithelialisation, but not complete healing, 5=100% re epithelialisation [complete healing]
    End point type
    Secondary
    End point timeframe
    Wound healing was assessed from Day 1 through Day 28.
    End point values
    		 Control Gel Petrolatum (ALLERGIKA® – BASISSALBE) Untreated control
    Number of subjects analysed
    11
    11
    11
    Units: Clinical Score per Day
    median (full range (min-max))
        Day 2
    0 (0 to 1)
    0 (0 to 0)
    0 (0 to 0)
        Day 3
    1 (0 to 1)
    1 (0 to 1)
    1 (0 to 2)
        Day 4
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 2)
        Day 5
    1 (1 to 2)
    1 (1 to 2)
    1 (1 to 2)
        Day 6
    2 (1 to 4)
    2 (1 to 3)
    2 (1 to 3)
        Day 7
    2.5 (2 to 4)
    3 (2 to 4)
    3 (1 to 4)
        Day 8
    3 (2 to 4)
    3.5 (2 to 4)
    3 (2 to 4)
        Day 9
    3.5 (3 to 4)
    3.5 (3 to 4)
    4 (3 to 4)
        Day 10
    4 (3 to 4)
    4 (3 to 4)
    4 (4 to 4)
        Day 11
    4 (4 to 5)
    4 (3 to 5)
    4 (4 to 5)
        Day 12
    4 (4 to 5)
    4 (4 to 5)
    4 (4 to 5)
        Day 13
    4.5 (4 to 5)
    5 (4 to 5)
    4.5 (4 to 5)
        Day 14
    5 (4 to 5)
    5 (4 to 5)
    5 (4 to 5)
        Day 15
    5 (5 to 5)
    5 (4 to 5)
    5 (4 to 5)
        Day 16 to 28
    5 (5 to 5)
    5 (5 to 5)
    5 (5 to 5)
    No statistical analyses for this end point

    Secondary: Mean TEWL Per Wound

    		 Close Top of page
    End point title
    		 Mean TEWL Per Wound
    End point description
    TEWL was measured according to international guidelines.
    End point type
    Secondary
    End point timeframe
    Transepidermal water loss (TEWL) was assessed from Day 1 through Day 28.
    End point values
    		 Control Gel Petrolatum (ALLERGIKA® – BASISSALBE) Untreated control
    Number of subjects analysed
    12 [3]
    12 [4]
    12 [5]
    Units: TEWL Per Day (g/m2/h)
    arithmetic mean (standard deviation)
        Day 1
    76.2 ± 9.4
    75.5 ± 11.0
    77.4 ± 6.7
        Day 3
    73.3 ± 7.7
    74.6 ± 6.7
    76.1 ± 4.8
        Day 5
    58.2 ± 13.4
    62.6 ± 12.2
    60.3 ± 13.7
        Day 7
    23.7 ± 15.6
    26.5 ± 19.5
    25.1 ± 18.4
        Day 9
    14.0 ± 13.9
    15.1 ± 18.0
    15.5 ± 17.9
        Day 11
    9.0 ± 2.7
    11.2 ± 9.4
    11.3 ± 8.3
        Day 13
    10.7 ± 1.9
    10.8 ± 2.9
    12.8 ± 3.4
        Day 15
    12.8 ± 3.6
    11.4 ± 2.9
    13.8 ± 3.9
        Day 17
    11.4 ± 3.1
    10.2 ± 3.2
    11.5 ± 2.1
        Day 19
    10.4 ± 2.4
    9.0 ± 1.5
    10.1 ± 1.9
        Day 21
    10.3 ± 3.3
    9.0 ± 1.7
    9.9 ± 1.6
        Day 23
    8.8 ± 1.8
    8.7 ± 2.1
    8.8 ± 1.6
        Day 28
    9.9 ± 2.7
    10.3 ± 3.0
    10.0 ± 2.8
    Notes
    [3] - Day 1 to 13: N=12; Day 15 to 28: N=11
    [4] - Day 1 to 13: N=12; Day 15 to 28: N=11
    [5] - Day 1 to 13: N=12; Day 15 to 28: N=11
    No statistical analyses for this end point

    Secondary: Mean Wound Surface Area According to Planimetry

    		 Close Top of page
    End point title
    		 Mean Wound Surface Area According to Planimetry
    End point description
    For measurement of wound area, standardised photographs of each wound were taken; at least two photographs were taken at each timepoint and the best image (after assessment for clarity and quality) was stored for subsequent image analysis. Wound healing measurements (planimetry) were performed by computerised image analysis using the software ImageJ.
    End point type
    Secondary
    End point timeframe
    Wound healing was assessed from Day 1 through Day 28.
    End point values
    		 Control Gel Petrolatum (ALLERGIKA® – BASISSALBE) Untreated control
    Number of subjects analysed
    12 [6]
    12 [7]
    12 [8]
    Units: Wound Surface Area Per Day (mm2)
    arithmetic mean (standard deviation)
        Day 1
    43.2 ± 8.1
    44.2 ± 5.5
    42.9 ± 5.8
        Day 3
    32.3 ± 7.3
    35.1 ± 5.8
    34.1 ± 5.7
        Day 5
    18.6 ± 6.2
    19.1 ± 4.9
    20.8 ± 8.2
        Day 7
    8.1 ± 6.7
    6.6 ± 4.0
    7.8 ± 7.4
        Day 9
    1.4 ± 1.9
    1.9 ± 2.5
    4.2 ± 9.9
        Day 11
    0.1 ± 0.2
    0.4 ± 1.0
    0.2 ± 0.6
        Day 13 to 28
    0.0 ± 0.0
    0.0 ± 0.0
    0.0 ± 0.0
    Notes
    [6] - Day 1 to 9: N=12; Day 11 to 28: N=11
    [7] - Day 1 to 9: N=12; Day 11 to 28: N=11
    [8] - Day 1 to 9: N=12; Day 11 to 28: N=11
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were monitored throughout the study from the time of informed consent through Day 28.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Petrolatum (ALLERGIKA® – BASISSALBE)
    Reporting group description
    		 Treatment with Petrolatum (ALLERGIKA® – BASISSALBE)

    Reporting group title
    Untreated control
    Reporting group description
    		 No topical treatment applied. Covered with a non adhesive wound dressing with a non adherent pad (Mepitel®Film) from Day 1 through Day 10.

    Reporting group title
    Control Gel
    Reporting group description
    		 Treatment with Control Gel

    Serious adverse events
    		 Petrolatum (ALLERGIKA® – BASISSALBE) Untreated control Control Gel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (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
    		 Petrolatum (ALLERGIKA® – BASISSALBE) Untreated control Control Gel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 12 (58.33%)
    8 / 12 (66.67%)
    9 / 12 (75.00%)
    General disorders and administration site conditions
    Medical device site papule
         subjects affected / exposed
    6 / 12 (50.00%)
    6 / 12 (50.00%)
    6 / 12 (50.00%)
         occurrences all number
    7
    7
    7
    Application site papules
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    4 / 12 (33.33%)
         occurrences all number
    1
    2
    4
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    1
    Infections and infestations
    Medical device site pustule
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    1

    More information

    		 Close Top of page

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 17 05:13:22 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA