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    Clinical Trial Results:
    A prospective, single center, randomized, double-blind, placebo controlled study in two phases to evaluate the safety and efficacy of ATx201 as a topical antibiotic agent

    Summary
    EudraCT number
    		 2016-003501-33
    Trial protocol
    		 AT  
    Global end of trial date
    12 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Oct 2019
    First version publication date
    31 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DECOLAD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UNION therapeutics A/S (formerly AntibioTx A/S)
    Sponsor organisation address
    Tuborg Havnevej 18, Hellerup, Denmark,
    Public contact
    UNION therapeutics A/S (formerly AntibioTx A/S), UNION therapeutics A/S (formerly AntibioTx A/S), +45 40103044, rasmus.toft-kehler@uniontherapeutics.com
    Scientific contact
    UNION therapeutics A/S (formerly AntibioTx A/S), UNION therapeutics A/S (formerly AntibioTx A/S), +45 40103044, rasmus.toft-kehler@uniontherapeutics.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
    11 Jan 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to demonstrate the safety and tolerability of topical formulations of ATx201 in healthy volunteers and in patients with atopic dermatitis (AD), and to assess efficacy of ATx201 in eradicating S. aureus compared to vehicle after 4 and 7 days of treatment. To determine the local and systemic exposure of ATx201 (Part 1 and 2) and best tolerable formulation to advance into Part 2 and to assess the impact of ATx201 on AD lesions (Part 2).
    Protection of trial subjects
    Safety and tolerability endpoints (Part 1 and 2): Physical exam, vital signs, ECG (Part 1 only), safety laboratory, number, type and severity of (serious) adverse events (AE), local tolerability assessment scores compared to vehicle.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 66
    Worldwide total number of subjects
    66
    EEA total number of subjects
    66
    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)
    66
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In part 1, 6 additional healthy volunteers were not exposed to the IP and were planned and enrolled for bioanalytical method validation.

    Pre-assignment
    Screening details
    		 The study was conducted in two Phases. In both Phases of the study subjects were screened at a Screening Visit. Part 1 (Phase 1) consisted of the screening Visit, a 7-day treatment period, and an end of study (EOS) visit on Day 15. Part 2 (Phase 2) consisted of a screening Visit, a 7-day treatment period, and an EOS visit on Day 14.

    Period 1
    Period 1 title
    Part 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Unblinded due to their profession were • Responsible staff for preparation of code break envelopes and • Responsible persons for production and labeling of the IP. On Day 8 of Part 1, blinding was broken before biopsy sampling, to detect areas that received active treatment. Routine unblinding of study subjects was prohibited, except for Part 1 in subjects undergoing biopsy sampling. Safety assessments were performed in the morning of Day 8. Biopsy samples were taken after the last application.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment arm 1
    Arm description
    		 Consisted of the screening Visit, a 7-day treatment period (subjects received two formulations of ATx201 and vehicle), and an end of study (EOS) visit on Day 15. Subjects were treated in 4 separate areas, 2 on the right arm and 2 on the right or left arm, twice daily at the study site. For the subjects biopsies were set on Day 8, one hour after 15th application (±10 minutes) of the IP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ATx201 Anhydrous Cream 2%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each subject in Part 1 was treated with four formulations (two active formulations and their corresponding vehicles). The IPs were applied to defined skin areas in the dorsal arms twice daily. The body area to be treated was circle marked with a skin marker and had a size of 5 cm in diameter. The expected dose of 80-200 mg of the dermal formulation corresponds to 1.6-4.0 mg active substance/day.

    Investigational medicinal product name
    ATx201 Anhydrous Cream Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each subject in Part 1 was treated with four formulations (two active formulations and their corresponding vehicles). The IPs were applied to defined skin areas in the dorsal arms twice daily. The body area to be treated was circle marked with a skin marker and had a size of 5 cm in diameter. The expected dose of 80-200 mg of the dermal formulation corresponds to 1.6-4.0 mg active substance/day.

    Investigational medicinal product name
    ATx201 GEL 2%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each subject in Part 1 was treated with four formulations (two active formulations and their corresponding vehicles). The IPs were applied to defined skin areas in the dorsal arms twice daily. The body area to be treated was circle marked with a skin marker and had a size of 5 cm in diameter. The expected dose of 80-200 mg of the dermal formulation corresponds to 1.6-4.0 mg active substance/day.

    Investigational medicinal product name
    ATx201 GEL Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each subject in Part 1 was treated with four formulations (two active formulations and their corresponding vehicles). The IPs were applied to defined skin areas in the dorsal arms twice daily. The body area to be treated was circle marked with a skin marker and had a size of 5 cm in diameter. The expected dose of 80-200 mg of the dermal formulation corresponds to 1.6-4.0 mg active substance/day.

    Arm title
    		 Treatment arm 2
    Arm description
    		 Consisted of the screening Visit, a 7-day treatment period (subjects received two formulations of ATx201 and vehicle), and an end of study (EOS) visit on Day 15. Subjects were treated in 4 separate areas, 2 on the right arm and 2 on the right or left arm, twice daily at the study site. For the subjects biopsies were set on Day 8, one hour after 15th application (±10 minutes) of the IP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ATx201 Anhydrous Cream 2%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each subject in Part 1 was treated with four formulations (two active formulations and their corresponding vehicles). The IPs were applied to defined skin areas in the dorsal arms twice daily. The body area to be treated was circle marked with a skin marker and had a size of 5 cm in diameter. The expected dose of 80-200 mg of the dermal formulation corresponds to 1.6-4.0 mg active substance/day.

    Investigational medicinal product name
    ATx201 Anhydrous Cream Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each subject in Part 1 was treated with four formulations (two active formulations and their corresponding vehicles). The IPs were applied to defined skin areas in the dorsal arms twice daily. The body area to be treated was circle marked with a skin marker and had a size of 5 cm in diameter. The expected dose of 80-200 mg of the dermal formulation corresponds to 1.6-4.0 mg active substance/day.

    Investigational medicinal product name
    ATx201 Cream 2%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each subject in Part 1 was treated with four formulations (two active formulations and their corresponding vehicles). The IPs were applied to defined skin areas in the dorsal arms twice daily. The body area to be treated was circle marked with a skin marker and had a size of 5 cm in diameter. The expected dose of 80-200 mg of the dermal formulation corresponds to 1.6-4.0 mg active substance/day.

    Investigational medicinal product name
    ATx201 Cream Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each subject in Part 1 was treated with four formulations (two active formulations and their corresponding vehicles). The IPs were applied to defined skin areas in the dorsal arms twice daily. The body area to be treated was circle marked with a skin marker and had a size of 5 cm in diameter. The expected dose of 80-200 mg of the dermal formulation corresponds to 1.6-4.0 mg active substance/day.

    Arm title
    		 Treatment arm 3
    Arm description
    		 Consisted of the screening Visit, a 7-day treatment period (subjects received two formulations of ATx201 and vehicle), and an end of study (EOS) visit on Day 15. Subjects were treated in 4 separate areas, 2 on the right arm and 2 on the right or left arm, twice daily at the study site. For the subjects biopsies were set on Day 8, one hour after 15th application (±10 minutes) of the IP.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ATx201 GEL 2%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each subject in Part 1 was treated with four formulations (two active formulations and their corresponding vehicles). The IPs were applied to defined skin areas in the dorsal arms twice daily. The body area to be treated was circle marked with a skin marker and had a size of 5 cm in diameter. The expected dose of 80-200 mg of the dermal formulation corresponds to 1.6-4.0 mg active substance/day.

    Investigational medicinal product name
    ATx201 GEL Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each subject in Part 1 was treated with four formulations (two active formulations and their corresponding vehicles). The IPs were applied to defined skin areas in the dorsal arms twice daily. The body area to be treated was circle marked with a skin marker and had a size of 5 cm in diameter. The expected dose of 80-200 mg of the dermal formulation corresponds to 1.6-4.0 mg active substance/day.

    Investigational medicinal product name
    ATx201 Cream 2%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each subject in Part 1 was treated with four formulations (two active formulations and their corresponding vehicles). The IPs were applied to defined skin areas in the dorsal arms twice daily. The body area to be treated was circle marked with a skin marker and had a size of 5 cm in diameter. The expected dose of 80-200 mg of the dermal formulation corresponds to 1.6-4.0 mg active substance/day.

    Investigational medicinal product name
    ATx201 Cream Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each subject in Part 1 was treated with four formulations (two active formulations and their corresponding vehicles). The IPs were applied to defined skin areas in the dorsal arms twice daily. The body area to be treated was circle marked with a skin marker and had a size of 5 cm in diameter. The expected dose of 80-200 mg of the dermal formulation corresponds to 1.6-4.0 mg active substance/day.

    Arm title
    		 Method testing arm
    Arm description
    		 Six healthy volunteers were enrolled for method testing.
    Arm type
    		 method testing- non IMP arm

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1 [1]
    		Treatment arm 1 Treatment arm 2 Treatment arm 3 Method testing arm
    Started
    10
    10
    10
    6
    Completed
    10
    10
    10
    6
    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: In part 1 36 healthy subjects were enrolled, in part 2 36 patients with atopic dermatitis. In total 72 patients were enrolled in trial.
    Period 2
    Period 2 title
    Part 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    On Day 8 of Part 1, blinding was broken before biopsy sampling, in order to detect the areas that received active treatment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment arm 1
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ATx201 GEL 2%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each patient applied ATx201 GEL 2% and matching vehicle to defined treatment areas between 10-200 cm2 once daily.

    Investigational medicinal product name
    ATx201 GEL Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each patient applied ATx201 GEL 2% and matching vehicle to defined treatment areas between 10-200 cm2 once daily.

    Arm title
    		 Treatment arm 2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ATx201 GEL 2%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each patient applied ATx201 GEL 2% and matching vehicle to defined treatment areas between 10-200 cm2 twice daily.

    Investigational medicinal product name
    ATx201 GEL Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Each patient applied ATx201 GEL 2% and matching vehicle to defined treatment areas between 10-200 cm2 twice daily.

    Number of subjects in period 2
    		Treatment arm 1 Treatment arm 2
    Started
    18
    18
    Completed
    18
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment arm 1
    Reporting group description
    		 Consisted of the screening Visit, a 7-day treatment period (subjects received two formulations of ATx201 and vehicle), and an end of study (EOS) visit on Day 15. Subjects were treated in 4 separate areas, 2 on the right arm and 2 on the right or left arm, twice daily at the study site. For the subjects biopsies were set on Day 8, one hour after 15th application (±10 minutes) of the IP.

    Reporting group title
    Treatment arm 2
    Reporting group description
    		 Consisted of the screening Visit, a 7-day treatment period (subjects received two formulations of ATx201 and vehicle), and an end of study (EOS) visit on Day 15. Subjects were treated in 4 separate areas, 2 on the right arm and 2 on the right or left arm, twice daily at the study site. For the subjects biopsies were set on Day 8, one hour after 15th application (±10 minutes) of the IP.

    Reporting group title
    Treatment arm 3
    Reporting group description
    		 Consisted of the screening Visit, a 7-day treatment period (subjects received two formulations of ATx201 and vehicle), and an end of study (EOS) visit on Day 15. Subjects were treated in 4 separate areas, 2 on the right arm and 2 on the right or left arm, twice daily at the study site. For the subjects biopsies were set on Day 8, one hour after 15th application (±10 minutes) of the IP.

    Reporting group title
    Method testing arm
    Reporting group description
    		 Six healthy volunteers were enrolled for method testing.

    Reporting group values
    		 Treatment arm 1 Treatment arm 2 Treatment arm 3 Method testing arm Total
    Number of subjects
    		 10 10 10 6 36
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 10 10 10 6 36
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 4 2 3 0 9
        Male
    		 6 8 7 6 27
    Subject analysis sets

    Subject analysis set title
    Part 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    30 healthy subjects received three formulations of ATx201 and vehicle. The treatment part of Part 1 consisted of a screening visit (Day 0), a randomization visit (Day 1, first treatment), a treatment period of 7 consecutive days (Days 1-7), a PK visit (Day 8), and an EOS (end of study) visit (Day 15±2 days).

    Subject analysis set title
    Part 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    36 patients (18 patients per group (once-daily vs twice-daily group) with a randomization ratio 1:1 with AD and colonized by S. aureus were enrolled.

    Subject analysis sets values
    		 Part 1 Part 2
    Number of subjects
    30
    36
    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)
    30
    36
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    30.33 ± 6.82
    32.86 ± 12.03
    Gender categorical
    Units: Subjects
        Female
    9
    18
        Male
    21
    18

    End points

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    End points reporting groups
    Reporting group title
    Treatment arm 1
    Reporting group description
    		 Consisted of the screening Visit, a 7-day treatment period (subjects received two formulations of ATx201 and vehicle), and an end of study (EOS) visit on Day 15. Subjects were treated in 4 separate areas, 2 on the right arm and 2 on the right or left arm, twice daily at the study site. For the subjects biopsies were set on Day 8, one hour after 15th application (±10 minutes) of the IP.

    Reporting group title
    Treatment arm 2
    Reporting group description
    		 Consisted of the screening Visit, a 7-day treatment period (subjects received two formulations of ATx201 and vehicle), and an end of study (EOS) visit on Day 15. Subjects were treated in 4 separate areas, 2 on the right arm and 2 on the right or left arm, twice daily at the study site. For the subjects biopsies were set on Day 8, one hour after 15th application (±10 minutes) of the IP.

    Reporting group title
    Treatment arm 3
    Reporting group description
    		 Consisted of the screening Visit, a 7-day treatment period (subjects received two formulations of ATx201 and vehicle), and an end of study (EOS) visit on Day 15. Subjects were treated in 4 separate areas, 2 on the right arm and 2 on the right or left arm, twice daily at the study site. For the subjects biopsies were set on Day 8, one hour after 15th application (±10 minutes) of the IP.

    Reporting group title
    Method testing arm
    Reporting group description
    		 Six healthy volunteers were enrolled for method testing.
    Reporting group title
    Treatment arm 1
    Reporting group description
    		 -

    Reporting group title
    Treatment arm 2
    Reporting group description
    		 -

    Subject analysis set title
    Part 1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    30 healthy subjects received three formulations of ATx201 and vehicle. The treatment part of Part 1 consisted of a screening visit (Day 0), a randomization visit (Day 1, first treatment), a treatment period of 7 consecutive days (Days 1-7), a PK visit (Day 8), and an EOS (end of study) visit (Day 15±2 days).

    Subject analysis set title
    Part 2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    36 patients (18 patients per group (once-daily vs twice-daily group) with a randomization ratio 1:1 with AD and colonized by S. aureus were enrolled.

    Primary: Primary efficacy endpoint Day 4 (Part 2) ATx201 GEL 2%

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    End point title
    		 Primary efficacy endpoint Day 4 (Part 2) ATx201 GEL 2% [1]
    End point description
    Treatment success was defined as a 100-fold reduction in the S. aureus CFU/cm2 of samples skin lesion on Day 4. Once-daily group is Treatment arm 1 and the Twice-daily group is Treatment arm 2. Treatment for both treatment arms: ATx201 Gel 2%.
    End point type
    Primary
    End point timeframe
    After 4 days of treatment.
    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: No statistical hypotheses were tested.
    End point values
    		 Treatment arm 1 Treatment arm 2
    Number of subjects analysed
    18
    18
    Units: Treatment success
        Treatment success
    10
    13
        Total
    18
    18
    No statistical analyses for this end point

    Primary: Primary safety and tolerability endpoint

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    End point title
    		 Primary safety and tolerability endpoint [2]
    End point description
    Neither Part 1 or Part 2 demonstrated any safety concerns. The safety endpoint was achieved. No systemic AEs were reported related to the study treatment. Skin reactions were reported as related to the study treatment.
    End point type
    Primary
    End point timeframe
    Overall trial
    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: No statistical hypotheses were tested.
    End point values
    		 Part 1 Part 2
    Number of subjects analysed
    30
    36
    Units: Related skin reactions
        Skin reactions
    0
    6
    No statistical analyses for this end point

    Primary: Primary efficacy endpoint Day 7 (Part 2) ATx201 GEL 2%

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    End point title
    		 Primary efficacy endpoint Day 7 (Part 2) ATx201 GEL 2% [3]
    End point description
    Treatment success was defined as a 100-fold reduction in the S. aureus CFU/cm2 of samples skin lesion on Day 7. Once-daily group is treatment arm 1 and the twice-daily group is treatment arm 2. Treatment for both treatment arms: ATx201 Gel 2%.
    End point type
    Primary
    End point timeframe
    After 7 days of treatment.
    Notes
    [3] - 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: No statistical hypotheses were tested.
    End point values
    		 Treatment arm 1 Treatment arm 2
    Number of subjects analysed
    18
    18
    Units: Treatment success
        Treatment success
    9
    17
        Total
    18
    18
    No statistical analyses for this end point

    Primary: Primary efficacy endpoint Day 4 (Part 2) Vehicle

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    End point title
    		 Primary efficacy endpoint Day 4 (Part 2) Vehicle [4]
    End point description
    Treatment success was defined as a 100-fold reduction in the S. aureus CFU/cm2 of samples skin lesion on Day 4. Once-daily group is Treatment arm 1 and the Twice-daily group is Treatment arm 2. Treatment for both treatment arms: Vehicle.
    End point type
    Primary
    End point timeframe
    After 4 days of treatment.
    Notes
    [4] - 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: No statistical hypotheses were tested.
    End point values
    		 Treatment arm 1 Treatment arm 2
    Number of subjects analysed
    18
    18
    Units: Treatment success
    3
    9
    No statistical analyses for this end point

    Primary: Primary efficacy endpoint Day 7 (Part 2) Vehicle

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    End point title
    		 Primary efficacy endpoint Day 7 (Part 2) Vehicle [5]
    End point description
    Treatment success was defined as a 100-fold reduction in the S. aureus CFU/cm2 of samples skin lesion on Day 7. Once-daily group is Treatment arm 1 and the Twice-daily group is Treatment arm 2. Treatment for both treatment arms: Vehicle.
    End point type
    Primary
    End point timeframe
    After 7 days of treatment.
    Notes
    [5] - 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: No statistical hypotheses were tested.
    End point values
    		 Treatment arm 1 Treatment arm 2
    Number of subjects analysed
    18
    18
    Units: Treatment success
    6
    7
    No statistical analyses for this end point

    Secondary: Secondary efficacy endpoint (Part 2)

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    End point title
    		 Secondary efficacy endpoint (Part 2)
    End point description
    Relative decrease of S. aureus colonies/cm2 on treated skin after treatment of the active groups, relative to their vehicles as well as relative to the untreated area. The Once-daily group is the Treatment arm 1 and the Twice-daily group is the Treatment arm 2.
    End point type
    Secondary
    End point timeframe
    The ratio of colony count was measured on Day 7 compared to Baseline.
    End point values
    		 Treatment arm 1 Treatment arm 2
    Number of subjects analysed
    18
    18
    Units: ratio of colony count
    arithmetic mean (standard deviation)
        Active
    16377 ± 32181
    143305.8 ± 455680.7
        Vehicle
    978 ± 3648
    23787.9 ± 91357.9
        Untreated
    23 ± 28
    83.6 ± 220.9
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial (Part 1 and Part 2).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Part 1
    Reporting group description
    		 -

    Reporting group title
    Part 2
    Reporting group description
    		 -

    Serious adverse events
    		 Part 1 Part 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 36 (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: 5%
    Non-serious adverse events
    		 Part 1 Part 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 30 (33.33%)
    26 / 36 (72.22%)
    Injury, poisoning and procedural complications
    Road traffic accident
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    3 / 30 (10.00%)
    5 / 36 (13.89%)
         occurrences all number
    3
    5
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Burning sensation
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 36 (8.33%)
         occurrences all number
    0
    3
    Inflammation
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 30 (3.33%)
    2 / 36 (5.56%)
         occurrences all number
    1
    3
    Vomiting
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 36 (2.78%)
         occurrences all number
    1
    2
    Reproductive system and breast disorders
    Menstrual disorder
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Viral upper respiratory tract infection
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    3 / 30 (10.00%)
    1 / 36 (2.78%)
         occurrences all number
    3
    1
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 30 (0.00%)
    12 / 36 (33.33%)
         occurrences all number
    0
    13
    Pruritus
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 36 (5.56%)
         occurrences all number
    0
    3
    Rash
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    Erythema
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 36 (2.78%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Back pain
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 36 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Apr 2017
    The address of the sponsor was amended. Additional 10 patients were planned for an extended pharmokinetic study. Therefore these patients got a higher payment for participation. Additional inclusion criteria were added, i.e. colonisation of lesions with S. aureus. Inclusion criteria were canceled, i.e. caffeine and tobacco consumption. Exclusion criteria were amended, i.e. concomitant medication was extended. Additional two co-workers were added to the protocol.
    30 May 2017
    Participation time of patients was reduced for two days. The overall time of the clinical trial was reduced for one month. Additional inclusion criteria were defined. Additional 3 co-workers were included. The number of S.aureus swabs was increased.

    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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