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    Clinical Trial Results:
    The Pathogenic Role Of Staphylococcus Aureus And The Skin Microbiome During Flare And Resolution Of Atopic Dermatitis

    Summary
    EudraCT number
    		 2021-006883-25
    Trial protocol
    		 DK  
    Global end of trial date
    13 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 May 2025
    First version publication date
    16 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AR-AB-AD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05578482
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Jacob Thyssen
    Sponsor organisation address
    Bispebjerg Bakke 23, Dermato-Venerologisk afdeling D92, Nielsine Nielsens Vej 9, Enterance 4, Second, Copenhagen NV, Denmark, 2400
    Public contact
    Dermato-Venerologisk afdeling, Biepebjerg Hospital, 0045 38636173, jacob.pontoppidan.thyssen@regionh.dk
    Scientific contact
    Dermato-Venerologisk afdeling, Biepebjerg Hospital, 0045 38636173, jacob.pontoppidan.thyssen@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
    Interim
    Date of interim/final analysis
    29 Apr 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We hypothesize: use of oral systemic antibiotic treatment with dicloxacillin (1000 mg x 3 times a day) will decrease the time to AD improvement as well as the amount of S. aureus and its toxins and alter the skin microbiome. Specifically, we aim to investigate the following research questions: • RQ1: Does the addition of systemic dicloxacillin to TCS treatment result in a more rapid and deeper treatment response? • RQ2: Does the addition of systemic dicloxacillin to TCS treatment affect the skin microbiome, the skin barrier and immune response during improvement of AD? • RQ3: Does topical application of S. aureus or SEB increase the severity and rapidity of a flare? • RQ4: Does topical application of S. aureus and SEB alter the skin microbiome, the skin barrier and immune response during a flare of AD? • RQ5: Can changes in protein expression or metabolic pathways explain the modulated mechanisms in the host-microbial cross talk of AD?
    Protection of trial subjects
    The study was monitored by the Good Clinical Practice (GCP) unit of Region H (https://gcp-enhed.dk/english/).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Oct 2022
    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: 45
    Worldwide total number of subjects
    45
    EEA total number of subjects
    45
    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)
    45
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from the Department of Dermatology, Bispebjerg Hospital, other dermatology departments including private clinics in the area near Copenhagen. Further, patients were recruited through webpages pointed out and approved in the protocol.

    Pre-assignment
    Screening details
    		 Patients were screened prior to inclusion to ensure that they fulfilled the inclusion criterias e.g. Age 18 years or above, European ancestry, AD diagnosis according to Hanifin & Rajka criteria, AD for at least 3 years, AD that is moderate-to-severe defined as an EASI score of ≥ 7, AD in the sampled location that has an TLSS score of ≥ 5.

    Period 1
    Period 1 title
    Study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    All participants and investigators who were involved in the screening, clinical visits and analysis during the study were blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Dicloxacillin 1000 mg three times daily in five days + Elocon 0.1 % Topical Cream.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dicloxacillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg dicloxacillin 3 times daily in five days.

    Investigational medicinal product name
    Mometasone futurate 0.1%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use, Topical use
    Dosage and administration details
    All patients were instructed to use the TCS creme (mometasone futurate 0.1%) once daily at areas where AD is active. If the AD was located in the face or at intimate regions patients were instructed to use their regular treatment for this area (hydrocortisone, hydrocortison-17-butyrat, topical tacrolimus 0.1% or pimecrolimus 1%) instead. The tubes of mometasone futurate 0.1% were weighed prior to study start and in the end of day 5.

    Arm title
    		 Placebo
    Arm description
    		 Placebo + TCS creme (mometasone futurate 0.1%) once daily at areas where AD is active. If the AD is located in the face or at intimate regions patients will be instructed to use their regular treatment for this area (hydrocortisone, hydrocortison-17-butyrat, topical tacrolimus 0.1% or pimecrolimus 1%) instead.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Mometasone futurate 0.1%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use, Topical use
    Dosage and administration details
    All patients were instructed to use the TCS creme (mometasone futurate 0.1%) once daily at areas where AD is active. If the AD was located in the face or at intimate regions patients were instructed to use their regular treatment for this area (hydrocortisone, hydrocortison-17-butyrat, topical tacrolimus 0.1% or pimecrolimus 1%) instead. The tubes of mometasone futurate 0.1% were weighed prior to study start and in the end of day 5.

    Number of subjects in period 1 [1]
    		Active Placebo
    Started
    20
    21
    Completed
    19
    21
    Not completed
    1
    0
         Consent withdrawn by subject
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 41 patients were enrolled in the trial. One dropped out due to personal circumstances resulting in a total of 40 patients completing the trial.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study period
    Reporting group description
    		 -

    Reporting group values
    		 Study period Total
    Number of subjects
    		 41 41
    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)
    		 41 41
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 30 30
        Male
    		 11 11

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Dicloxacillin 1000 mg three times daily in five days + Elocon 0.1 % Topical Cream.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo + TCS creme (mometasone futurate 0.1%) once daily at areas where AD is active. If the AD is located in the face or at intimate regions patients will be instructed to use their regular treatment for this area (hydrocortisone, hydrocortison-17-butyrat, topical tacrolimus 0.1% or pimecrolimus 1%) instead.

    Primary: Effect of treatment on TLSS change over time

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    End point title
    		 Effect of treatment on TLSS change over time
    End point description
    A mixed effects model was fit using the following formula: total_tlss ~ visit * treatment_unblinded + (visit | study_id). This formula included covariates for visit (continuous, 1-5) and treatment(Active/Placebo) including a random interaction term of patient for each study day. A significant effect of treatment was assumed if the interaction term between visit:treatment was significant.
    End point type
    Primary
    End point timeframe
    Day 1-5.
    End point values
    		 Active Placebo
    Number of subjects analysed
    19
    21
    Units: Interaction effect
        number (confidence interval 95%)
    -0.953 (-1.148 to -0.758)
    -0.967 (-1.152 to -0.782)
    Statistical analysis title
    		 Mixed effects model
    Statistical analysis description
    The analysis implemented the lmerTest method from the lmerTest package in R. This implements atterthwaite's degrees of freedom method for calculating p-values and confidence intervals for covariates in a linear mixed-effects model.
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.916 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Slope
    Point estimate
    0.014
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.246
         upper limit
    		 0.274
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.133
    Notes
    [1] - This is the reported p-value of the interaction term (visit:treatment). Thus, we are unable to disprove the null hypothesis that docloxicicillin treatment does not significantly change the effect of corticosteroid treatment on TLSS severity.

    Secondary: Daily change in EASI

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    End point title
    		 Daily change in EASI
    End point description
    A mixed effects model was fit using the following formula: total_easi ~ visit * treatment_unblinded + (visit | study_id). This formula included covariates for visit (continuous, 1-5) and treatment(Active/Placebo) including a random interaction term of patient for each study day. A significant effect of treatment was assumed if the interaction term between visit:treatment was significant.
    End point type
    Secondary
    End point timeframe
    Day 1-5.
    End point values
    		 Active Placebo
    Number of subjects analysed
    19
    21
    Units: Estimated daily change in EASI
        number (confidence interval 95%)
    -2.052 (-2.677 to -1.427)
    -2.607 (-3.210 to -2.003)
    Statistical analysis title
    		 Mixed effects model - EASI
    Statistical analysis description
    The analysis implemented the lmerTest method from the lmerTest package in R. This implements atterthwaite's degrees of freedom method for calculating p-values and confidence intervals for covariates in a linear mixed-effects model.
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.204 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Slope
    Point estimate
    0.555
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.286
         upper limit
    		 1.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.429
    Notes
    [2] - This is the reported p-value of the interaction term (visit:treatment). Thus, we are unable to disprove the null hypothesis that docloxicicillin treatment does not significantly change the effect of corticosteroids on EASI change.

    Secondary: Daily change in itch

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    End point title
    		 Daily change in itch
    End point description
    A mixed effects model was fit using the following formula: itch ~ visit * treatment_unblinded + (visit | study_id).
    End point type
    Secondary
    End point timeframe
    Day 1-5
    End point values
    		 Active Placebo
    Number of subjects analysed
    19
    21
    Units: Change in itch
        number (confidence interval 95%)
    -1.23 (-1.5 to -1.0)
    -0.95 (-1.2 to -0.7)
    Statistical analysis title
    		 Mixed effects model - Itch NRS
    Statistical analysis description
    The analysis implemented the lmerTest method from the lmerTest package in R. This implements atterthwaite's degrees of freedom methom for calculating p-values and confidence intervals for covariates in a linear mixed-effects model.
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1 [3]
    Method
    		 Mixed models analysis
    Parameter type
    		 Slope
    Point estimate
    -0.279
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.046
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.17
    Notes
    [3] - This is the reported p-value of the interaction term (visit:treatment). Thus, we are unable to disprove the null hypothesis that docloxicicillin treatment does not significantly change the effect of corticosteroid treatment on Itch.

    Secondary: Daily change in Sleep NRS

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    End point title
    		 Daily change in Sleep NRS
    End point description
    A mixed effects model was fit using the following formula: sleep ~ visit * treat-ment_unblinded + (visit | study_id).
    End point type
    Secondary
    End point timeframe
    Day 1-5.
    End point values
    		 Active Placebo
    Number of subjects analysed
    19
    21
    Units: Change in sleep
        number (confidence interval 95%)
    -0.49 (-0.824 to -0.156)
    -0.6 (-0.922 to -0.278)
    Statistical analysis title
    		 Mixed effects model - Sleep
    Statistical analysis description
    This formula included covariates for visit (continuous, 1-5) and treatment(Active/Placebo) including a random interaction term of patient for each study day. A significant effect of treatment was assumed if the interaction term between visit:treatment was significant.
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.634 [4]
    Method
    		 Mixed models analysis
    Parameter type
    		 Slope
    Point estimate
    -0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.34
         upper limit
    		 0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Notes
    [4] - This is the reported p-value of the interaction term (visit:treatment). Thus, we are unable to dis-prove the null hypothesis that dicloxacillin treatment does not significantly change the effect of corticosteroid treatment on sleep NRS.

    Secondary: Daily change in pain-NRS

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    End point title
    		 Daily change in pain-NRS
    End point description
    A mixed effects model was fit using the following formula: pain ~ visit * treat-ment_unblinded + (visit | study_id).
    End point type
    Secondary
    End point timeframe
    Day 1-5.
    End point values
    		 Active Placebo
    Number of subjects analysed
    19
    21
    Units: Change in pain-NRS
        number (confidence interval 95%)
    -0.945 (-1.195 to -0.694)
    -0.99 (-1.227 to -0.744)
    Statistical analysis title
    		 Mixed effects model - Pain NRS
    Statistical analysis description
    This formula included covariates for visit (continuous, 1-5) and treatment(Active/Placebo) including a random interaction term of patient for each study day. A significant effect of treatment was assumed if the interaction term between visit:treatment was significant.
    Comparison groups
    Active v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.81 [5]
    Method
    		 Mixed models analysis
    Parameter type
    		 Slope
    Point estimate
    -0.041
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.38
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.17
    Notes
    [5] - This is the reported p-value of the interaction term (visit:treatment). Thus, we are unable to dis-prove the null hypothesis that dicloxacillin treatment does not significantly change the effect of corticosteroid treatment on pain NRS.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All reported adverse events are followed until dissolved or as clinically required. AE’s from first administration of the trail medication to 24 hours after the last administration of the trial medicine.
    Adverse event reporting additional description
    AE’s were collected each day at a clinical visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 0
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Active group receiving dicloxacillin 1000 mg x 3 times daily + topical mometasone furoate 0.1%.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo group receiving placebo + topical mometasone furoate 0.1%

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 19 (15.79%)
    3 / 21 (14.29%)
    Ear and labyrinth disorders
    Dizziness
    Additional description: Dizziness during change of a plaster.
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Social circumstances
    Fatigue
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Urticaria
    Additional description: Urticaria affecting the skin. No other additional symptoms.
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    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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