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    Clinical Trial Results:
    Biodistribution of ablative fractional laser-assisted topical delivery of Vismodegib in basal cell carcinomas.

    Summary
    EudraCT number
    		 2019-002545-38
    Trial protocol
    		 DK  
    Global end of trial date
    01 Nov 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2023
    First version publication date
    16 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    68943
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bispebjerg Hospital
    Sponsor organisation address
    Bispebjerg Bakke 24, Copenhagen, Denmark, 2400
    Public contact
    Merete Hædersdal, Bispebjerg Hospital, Department of Dermatology, 0045 20416746, katrine.togsverd-bo@regionh.dk
    Scientific contact
    Merete Hædersdal, Bispebjerg Hospital, Department of Dermatology, 0045 20416746, katrine.togsverd-bo@regionh.dk
    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
    01 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Nov 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study aim is in BCCs exposed to AFL+topical vismodegib to determine 1) intra-tumoral vismodegib concentration and 2) the biologic response of vismodegib expressed by GLI mRNA level at 4 days. These results are compared with BCC-vismodegib concentration in patients undergoing systemic vismodegib treatment.
    Protection of trial subjects
    Basal cell carcinoma as low-malignant skin cancer that occur in up to 30% of patients older than 65 years. Recruited patients will undergo no experimental curative treatment and there are therefore no risk in terms of recurrence in the study. Patients will be secured up to 24 hours to consider their participation and can withdraw this at any time.
    Background therapy
    		 Background therapy include conventional treatment (surgical excision, curettage and cautery, radiation therapy) for primary tumors or continous systemic vismodegib in patients already assigned to this treatment
    Evidence for comparator
    		 No comparators are included
    Actual start date of recruitment
    15 Aug 2019
    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
    Denmark: 19
    Worldwide total number of subjects
    19
    EEA total number of subjects
    19
    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)
    2
    From 65 to 84 years
    16
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients are included from Bispebjerg Hospital Department of Dermatology and Department of Oncology, Herlev Hospital

    Pre-assignment
    Screening details
    		 Histologically verified basal cell carcinoma with a size of minimum 10mmØ

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 topical vismodegib
    Arm description
    		 Patients with simple BCC allocated topical vismodegib emulsion
    Arm type
    		 Experimental

    Investigational medicinal product name
    vismodegib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Vismodegib (Erivedge capsules) was formulated into a topical solution as a oil-in water micro-emulsion composed of phosphate buffer, tween80, soybean oil and dimethylsulfoxide. The concentration reached was 3.1-3.2mg/mL

    Arm title
    		 systemic vismodegib
    Arm description
    		 Patients receiving systemic vismodegib (erivedge) 150 mg daily for minimum 28 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    erivedge
    Investigational medicinal product code
    EMEA/H/C/002602
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Erivedge capsules 150 mg once daily (oral use) for minimum 28 days

    Investigational medicinal product name
    vismodegib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Vismodegib (Erivedge capsules) was formulated into a topical solution as a oil-in water micro-emulsion composed of phosphate buffer, tween80, soybean oil and dimethylsulfoxide. The concentration reached was 3.1-3.2mg/mL

    Number of subjects in period 1
    		topical vismodegib systemic vismodegib
    Started
    16
    3
    Completed
    16
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    topical vismodegib
    Reporting group description
    		 Patients with simple BCC allocated topical vismodegib emulsion

    Reporting group title
    systemic vismodegib
    Reporting group description
    		 Patients receiving systemic vismodegib (erivedge) 150 mg daily for minimum 28 days.

    Reporting group values
    		 topical vismodegib systemic vismodegib Total
    Number of subjects
    		 16 3 19
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 74 (59 to 80) 79 (73 to 84) -
    Gender categorical
    Units: Subjects
        Female
    		 5 3 8
        Male
    		 11 0 11
    BCC diameter
    Tumor area at inclusion mm2
    Units: mm
        median (full range (min-max))
    		 154 (98 to 252) 118 (106 to 766) -

    End points

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    End points reporting groups
    Reporting group title
    topical vismodegib
    Reporting group description
    		 Patients with simple BCC allocated topical vismodegib emulsion

    Reporting group title
    systemic vismodegib
    Reporting group description
    		 Patients receiving systemic vismodegib (erivedge) 150 mg daily for minimum 28 days.

    Subject analysis set title
    safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    To test safety of topical treatment

    Subject analysis set title
    hedgehog pathway expression
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    To analyse changes in expression of hedgehog pathway genes

    Subject analysis set title
    all patients
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    patients included with topical vismodegib treatment and systemic vismodegib treatment

    Primary: vismodegib tumor concentration

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    End point title
    		 vismodegib tumor concentration
    End point description
    At treatment day, after laser treatment, the tumor was covered with a hydrocolloid well and loaded with vismodegib emulsion. The patch was covered using a permeable film to keep it contained. The remaining vismodegib emulsion was removed with the hydrocolloid bandage day 1. At day 3-4 a punch biopsy was sampled from the tumor together with a blood test to quantify tissue and plasma vismodegib concentration
    End point type
    Primary
    End point timeframe
    day 3-4 after laser treatment and topical application
    End point values
    		 topical vismodegib systemic vismodegib all patients
    Number of subjects analysed
    16
    3
    19
    Units: micromole(s)/litre
        median (inter-quartile range (Q1-Q3))
    6.2 (2.1 to 249)
    9.5 (2.6 to 17.4)
    6.2 (2 to 249)
    Statistical analysis title
    		 mann-whitney
    Statistical analysis description
    comparisons were performed using mann-whitney when data were non-normally distibuted
    Comparison groups
    topical vismodegib v systemic vismodegib
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: vismodegib plasma concentration

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    End point title
    		 vismodegib plasma concentration
    End point description
    End point type
    Secondary
    End point timeframe
    vismodegib plasma concentration day 3-4 after topical application laser and vismodegib emulsion
    End point values
    		 topical vismodegib systemic vismodegib
    Number of subjects analysed
    16
    3
    Units: micromole(s)/litre
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    8.9 (8.8 to 13.7)
    Statistical analysis title
    		 mann-whitney
    Comparison groups
    topical vismodegib v systemic vismodegib
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: gli1

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    End point title
    		 gli1
    End point description
    End point type
    Secondary
    End point timeframe
    day 3 versus baseline
    End point values
    		 topical vismodegib systemic vismodegib hedgehog pathway expression
    Number of subjects analysed
    16
    3
    16
    Units: percentage
    51
    0
    51
    Statistical analysis title
    		 change gli1 expression
    Comparison groups
    topical vismodegib v hedgehog pathway expression
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: gli2 reduction

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    End point title
    		 gli2 reduction
    End point description
    End point type
    Secondary
    End point timeframe
    day 3-4 versus baseline values
    End point values
    		 topical vismodegib systemic vismodegib hedgehog pathway expression
    Number of subjects analysed
    16
    3
    16
    Units: percent
        median (inter-quartile range (Q1-Q3))
    55 (18 to 93)
    0 (0 to 0)
    55 (18 to 93)
    Statistical analysis title
    		 mann-whitney
    Comparison groups
    topical vismodegib v hedgehog pathway expression
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 change gli2 expression
    Comparison groups
    topical vismodegib v hedgehog pathway expression
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: ptch 1 reduction

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    End point title
    		 ptch 1 reduction
    End point description
    End point type
    Secondary
    End point timeframe
    day 3-4 versus baseline
    End point values
    		 topical vismodegib systemic vismodegib
    Number of subjects analysed
    16
    3
    Units: percent
        median (inter-quartile range (Q1-Q3))
    73 (17 to 92)
    0 (0 to 0)
    Statistical analysis title
    		 change ptch 1 expression
    Comparison groups
    topical vismodegib v systemic vismodegib
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: ptch 2 reduction

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    End point title
    		 ptch 2 reduction
    End point description
    End point type
    Secondary
    End point timeframe
    day 3-4 versus baseline
    End point values
    		 topical vismodegib systemic vismodegib
    Number of subjects analysed
    16
    3
    Units: percent
        median (inter-quartile range (Q1-Q3))
    73 (6 to 85)
    0 (0 to 0)
    Statistical analysis title
    		 change ptch 2 expression
    Comparison groups
    systemic vismodegib v topical vismodegib
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: local skin reactions

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    End point title
    		 local skin reactions [1]
    End point description
    End point type
    Secondary
    End point timeframe
    day 3 after lasre and topical vismodegib
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This was a descriptive assessment - as the other arm did not receive treatment there is nothing to be tested against
    End point values
    		 topical vismodegib safety
    Number of subjects analysed
    16
    16
    Units: event
        skin reaction
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    overall study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Topical vismodegib arm
    Reporting group description
    		 -

    Serious adverse events
    		 Topical vismodegib arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Topical vismodegib arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 16 (6.25%)
    Infections and infestations
    localized skin infection
    Additional description: skin infection in laser-treated skin
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1

    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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