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    Clinical Trial Results:
    Longevity of microwave thermolysis and botulinum toxin A for treatment of axillary hyperhidrosis: a randomized intra-individual trial

    Summary
    EudraCT number
    		 2021-000877-10
    Trial protocol
    		 DK  
    Global end of trial date
    24 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 May 2024
    First version publication date
    24 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MWTBTXA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05057117
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bispebjerg Hospital
    Sponsor organisation address
    Nielsine Nielsens Vej 17, Copenhagen NV, Denmark, 2400
    Public contact
    Merete Haedersdal, Bispebjerg Hospital, Department of Dermatology, 0045 24454393, merete.haedersdal@regionh.dk
    Scientific contact
    Gabriela Lladó Grove, Bispebjerg Hospital, Department of Dermatology, ggro0013@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
    24 Apr 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study aim is to assess and compare treatment effect of MWT and BTX-A for axillary hyperhidrosis with focus on longevity. We also aim to assess patient satisfaction, local skin responses and adverse reactions in relation to treatment.
    Protection of trial subjects
    Standard treatments and interventions. Telephone follow-up within the first two days, followed by multiple clinical follow-up points. Open contact to the treating clinician in case of questions during the entire trial.
    Background therapy
    		 No other therapies than the interventional treatments
    Evidence for comparator
    		 Comparison of two standard, evidence-based treatments
    Actual start date of recruitment
    27 Sep 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Scientific research
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was conducted in the clinical setting at Dept of Dermatology, Copenhagen University Hospital (Bispebjerg and Gentofte) including patients between 27.09.21 - 19.04.22

    Pre-assignment
    Screening details
    		 According to pre-defined inclusion and exclusion criteria

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Botulinum Toxin A
    Arm description
    		 Standard treatment with Botulinum Toxin A in one axilla
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Botulinum Toxin A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    50-100 U (units)

    Arm title
    		 Microwave Thermolysis
    Arm description
    		 Standard treatment with microwave thermolysis in the contralateral axilla
    Arm type
    		 Medical device

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Botulinum Toxin A Microwave Thermolysis
    Started
    30
    30
    Completed
    30
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 30 patients at baseline, each receiving treatment with BTX in one axilla and MWT in the contralateral (by randomization)

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 30 30
    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
    Age at baseline
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 26 (23 to 35) -
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 10 10
    Previous MWT treatment
    prior to study participation
    Units: Subjects
        yes
    		 0 0
        no
    		 30 30
    Previous BTX A treatment
    Prior to study participation
    Units: Subjects
        yes
    		 8 8
        no
    		 22 22
    BMI
    Body Mass Index
    Units: kg/m2
        median (inter-quartile range (Q1-Q3))
    		 23.1 (20.5 to 25.2) -
    BTX no of treatments
    BTX no of treatments previous to study participation
    Units: no. of treatments
        median (inter-quartile range (Q1-Q3))
    		 4 (2.5 to 5) -

    End points

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    End points reporting groups
    Reporting group title
    Botulinum Toxin A
    Reporting group description
    		 Standard treatment with Botulinum Toxin A in one axilla

    Reporting group title
    Microwave Thermolysis
    Reporting group description
    		 Standard treatment with microwave thermolysis in the contralateral axilla

    Primary: Axillary sweat reduction at 6 months FU

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    End point title
    		 Axillary sweat reduction at 6 months FU
    End point description
    Gravimetric test
    End point type
    Primary
    End point timeframe
    baseline compared to 6-months follow-up, comparing deltas for BTX and MWT
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: mg/5min
        median (inter-quartile range (Q1-Q3))
    32 (20 to 89)
    66 (35 to 95)
    Statistical analysis title
    		 Wilcoxon signed-rank test
    Statistical analysis description
    nonparametric test of paired data was applied
    Comparison groups
    Botulinum Toxin A v Microwave Thermolysis
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0124 [1]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - In favor of BTX

    Secondary: Axillary sweat reduction at 12 months FU

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    End point title
    		 Axillary sweat reduction at 12 months FU
    End point description
    Gravimetric test
    End point type
    Secondary
    End point timeframe
    baseline compared to 12-months follow-up, comparing deltas for BTX and MWT
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: mg/5min
        median (inter-quartile range (Q1-Q3))
    35 (19 to 76)
    47 (24 to 80)
    Statistical analysis title
    		 Wilcoxon signed-rank test
    Statistical analysis description
    nonparametric test of paired data was applied
    Comparison groups
    Botulinum Toxin A v Microwave Thermolysis
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.9508
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Axillary sweat HDSS at 6-months

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    End point title
    		 Axillary sweat HDSS at 6-months
    End point description
    Hyperhidrosis Disease Severity Scale 1-4
    End point type
    Secondary
    End point timeframe
    baseline compared to 6-months follow-up, comparing deltas for BTX and MWT
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: points
        median (inter-quartile range (Q1-Q3))
    2 (2 to 2)
    2 (2 to 2)
    Statistical analysis title
    		 Wilcoxon signed-rank test)
    Statistical analysis description
    nonparametric test of paired data was applied
    Comparison groups
    Botulinum Toxin A v Microwave Thermolysis
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    P-value
    		 = 0.4142
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [2] - Comparing BTX to MWT

    Secondary: Axillary sweat HDSS at 12-months

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    End point title
    		 Axillary sweat HDSS at 12-months
    End point description
    Hyperhidrosis Disease Severity Scale 1-4
    End point type
    Secondary
    End point timeframe
    baseline compared to 12-months follow-up, comparing deltas for BTX and MWT
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: points
        median (inter-quartile range (Q1-Q3))
    2 (2 to 3)
    2 (2 to 3)
    Statistical analysis title
    		 Wilcoxon signed-rank test
    Statistical analysis description
    nonparametric test of paired data was applied
    Comparison groups
    Botulinum Toxin A v Microwave Thermolysis
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.1025
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Axillary odor at 6-months FU

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    End point title
    		 Axillary odor at 6-months FU
    End point description
    Odor Scale 1-10
    End point type
    Secondary
    End point timeframe
    baseline compared to 6-months follow-up, comparing deltas for BTX and MWT
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: points
        median (inter-quartile range (Q1-Q3))
    3 (2 to 5)
    2.5 (2 to 5)
    Statistical analysis title
    		 Wilcoxon signed-rank test
    Statistical analysis description
    nonparametric test of paired data was applied
    Comparison groups
    Botulinum Toxin A v Microwave Thermolysis
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.6826
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Axillary odor at 12-months FU

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    End point title
    		 Axillary odor at 12-months FU
    End point description
    Odor Scale 1-10
    End point type
    Secondary
    End point timeframe
    baseline compared to 12-months follow-up, comparing deltas for BTX and MWT
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: points
        median (inter-quartile range (Q1-Q3))
    4 (2 to 7)
    2.5 (2 to 6)
    Statistical analysis title
    		 Wilcoxon signed-rank test
    Statistical analysis description
    nonparametric test of paired data was applied
    Comparison groups
    Botulinum Toxin A v Microwave Thermolysis
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0098
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: DLQI at 6-months

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    End point title
    		 DLQI at 6-months
    End point description
    Dermatology Life Quality Index 0-30
    End point type
    Secondary
    End point timeframe
    baseline compared to 6-months follow-up, comparing deltas for BTX and MWT
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: points
        median (inter-quartile range (Q1-Q3))
    3 (1 to 5)
    3 (1 to 6)
    Statistical analysis title
    		 Wilcoxon signed-rank test
    Statistical analysis description
    nonparametric test of paired data was applied
    Comparison groups
    Botulinum Toxin A v Microwave Thermolysis
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0857
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: DLQI at 12-months

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    End point title
    		 DLQI at 12-months
    End point description
    Dermatology Life Quality Index 0-30
    End point type
    Secondary
    End point timeframe
    baseline compared to 12-months follow-up, comparing deltas for BTX and MWT
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: points
        median (inter-quartile range (Q1-Q3))
    4 (1 to 7)
    4 (1 to 7)
    Statistical analysis title
    		 Wilcoxon signed-rank test
    Statistical analysis description
    nonparametric test of paired data was applied
    Comparison groups
    Botulinum Toxin A v Microwave Thermolysis
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.3745
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: HidroQoL at 6-months

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    End point title
    		 HidroQoL at 6-months
    End point description
    Hyperhidrosis Quality of Life Index 0-36
    End point type
    Secondary
    End point timeframe
    baseline compared to 6-months follow-up, comparing deltas for BTX and MWT
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: points
        median (inter-quartile range (Q1-Q3))
    8.5 (4 to 15)
    8.5 (5 to 15)
    Statistical analysis title
    		 Wilcoxon signed-rank test
    Statistical analysis description
    nonparametric test of paired data was applied
    Comparison groups
    Botulinum Toxin A v Microwave Thermolysis
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.4374
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: HidroQoL at 12-months

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    End point title
    		 HidroQoL at 12-months
    End point description
    Hyperhidrosis Quality of Life Index 0-36
    End point type
    Secondary
    End point timeframe
    baseline compared to 12-months follow-up, comparing deltas for BTX and MWT
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: points
        median (inter-quartile range (Q1-Q3))
    11.5 (4 to 19)
    11 (3 to 22)
    Statistical analysis title
    		 Wilcoxon signed-rank test
    Statistical analysis description
    nonparametric test of paired data was applied
    Comparison groups
    Botulinum Toxin A v Microwave Thermolysis
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.1761
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Procedure-related pain

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    End point title
    		 Procedure-related pain
    End point description
    VAS 0-10
    End point type
    Secondary
    End point timeframe
    On-site at baseline treatments, comparing BTX and MWT
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: points
        median (inter-quartile range (Q1-Q3))
    4.5 (3 to 7)
    3 (2 to 4)
    Statistical analysis title
    		 Wilcoxon signed-rank test
    Statistical analysis description
    nonparametric test of paired data was applied
    Comparison groups
    Botulinum Toxin A v Microwave Thermolysis
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Post-procedural pain

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    End point title
    		 Post-procedural pain
    End point description
    Likert 0-3
    End point type
    Secondary
    End point timeframe
    2 days after baseline treatments
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: points
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    1 (1 to 2)
    Statistical analysis title
    		 Wilcoxon signed-rank test
    Statistical analysis description
    nonparametric test of paired data was applied
    Comparison groups
    Microwave Thermolysis v Botulinum Toxin A
    Number of subjects included in analysis
    60
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 = 0.3173
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Patient satisfaction

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    End point title
    		 Patient satisfaction
    End point description
    Satisfied
    End point type
    Secondary
    End point timeframe
    Overall satisfaction at 12-months FU
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: points
        number (not applicable)
    24
    24
    No statistical analyses for this end point

    Secondary: Hair reduction

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    End point title
    		 Hair reduction
    End point description
    Likert 0-3
    End point type
    Secondary
    End point timeframe
    Baseline compared to 12-month FU, comparing BTX and MWT
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: points
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    2 (2 to 3)
    Statistical analysis title
    		 Wilcoxon signed-rank test
    Statistical analysis description
    nonparametric test of paired data was applied
    Comparison groups
    Botulinum Toxin A v Microwave Thermolysis
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Patient preference

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    End point title
    		 Patient preference
    End point description
    Preferred treatment
    End point type
    Secondary
    End point timeframe
    at 12-months FU, comparing BTX and MWT
    End point values
    		 Botulinum Toxin A Microwave Thermolysis
    Number of subjects analysed
    30
    30
    Units: points
        number (not applicable)
    5
    23
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    1 year after baseline for each patient
    Adverse event reporting additional description
    According to GCP and the Danish Medicines Agency with yearly reports
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious AE/AR above frequency threshold for reporting non-serious adverse events

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/38495540
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