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    Clinical Trial Results:
    A double blind, placebo controlled, randomised dose escalation trial to investigate the safety and efficacy of topical salbutamol in the improvement of scar appearance when applied to approximated wound margins in healthy volunteers. Short title: A trial to assess the safety and efficacy of topical salbutamol in healthy volunteers

    Summary
    EudraCT number
    2017-003118-15
    Trial protocol
    GB  
    Global end of trial date
    01 Jul 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Jan 2021
    First version publication date
    06 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    97807
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University Hospitals of Leicester - NHS Trust
    Sponsor organisation address
    Leicester Royal Infirmary, Infirmary Square, Leicester, United Kingdom, LE1 5WW
    Public contact
    David Fairlamb, ProTherax Ltd, +44 1274561815, davidfairlamb@protherax.com
    Scientific contact
    David Fairlamb, ProTherax Ltd, +44 1274561815, davidfairlamb@protherax.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
    23 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess the safety and tolerance of topically applied salbutamol gel, when applied topically to the approximated wound margins of male and female subjects following surgical incisions.
    Protection of trial subjects
    Trial subjects were recruited sequentially is escalating dose groups, and escalation of salbutamol concentrations (2.5mM, 5.0mM, and 10.0mM) was based on an assessment by an independent Data Safety Monitoring Committee (DSMC) which assessed safety of the IMP after the last patient of each group had reached Day 14
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 Oct 2017
    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
    United Kingdom: 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
    Subjects recruited to the study were healthy volunteers, recruited between Jan 2018 and 01 July 2018. Last subject competed follow-up in 01 July 2019. All subjects were recruited in the UK.

    Pre-assignment
    Screening details
    Healthy volunteers aged 18-50, who provided written informed consent, registered on The Over Volunteering Prevention System (TOPS), had a BMI of 15.0-35.0 kg/m2 and who had acceptable clinical laboratory tests. Total number of subjects screened was 51.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    This study was a double-blind trial using a placebo (vehicle) gel without salbutamol as the comparator. There was no visual, tactile or odour differences between the two gel products. All subjects, investigators and staff involved in trial related assessments were blinded to study treatment administered to each incision site.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Salbutamol Gel 2.5mM vs placebo
    Arm description
    Within patient study, in which an incision on one arm was dosed with Salbutamol Gel 2.5mM and one arm was dosed with placebo.
    Arm type
    IMP vs Placebo

    Investigational medicinal product name
    Salbutamol Gel 2.5mM
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1mL administered to the incisional wound site every day for 60 days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1mL administered to the incisional wound site daily for 60 days

    Arm title
    Salbutamol Gel 5.0mM vs Placebo
    Arm description
    Within subject comparison of salbutamol Gel 5.0mM administered to a wound on one arm compared with Placebo Gel administered to the contralateral arm
    Arm type
    IMP vs Placebo

    Investigational medicinal product name
    Salbutamol Gel 5.0mM
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1mL administered to the incisional wound site daily for 60 days.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1mL administered to the incisional wound site daily for 60 days

    Arm title
    Salbutamol Gel 10mM vs placebo
    Arm description
    Within subject comparison in which Salbutamol Gel 10mM was administered to one arm and placebo gel to the contralateral arm
    Arm type
    IMP vs Placebo

    Investigational medicinal product name
    Salbutamol 10mM Gel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1mL administered to the incisional wound site daily for 60 days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Cutaneous use
    Dosage and administration details
    1mL administered to the incisional wound site daily for 60 days

    Number of subjects in period 1
    Salbutamol Gel 2.5mM vs placebo Salbutamol Gel 5.0mM vs Placebo Salbutamol Gel 10mM vs placebo
    Started
    15
    15
    15
    Completed
    15
    15
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Salbutamol Gel 2.5mM vs placebo
    Reporting group description
    Within patient study, in which an incision on one arm was dosed with Salbutamol Gel 2.5mM and one arm was dosed with placebo.

    Reporting group title
    Salbutamol Gel 5.0mM vs Placebo
    Reporting group description
    Within subject comparison of salbutamol Gel 5.0mM administered to a wound on one arm compared with Placebo Gel administered to the contralateral arm

    Reporting group title
    Salbutamol Gel 10mM vs placebo
    Reporting group description
    Within subject comparison in which Salbutamol Gel 10mM was administered to one arm and placebo gel to the contralateral arm

    Reporting group values
    Salbutamol Gel 2.5mM vs placebo Salbutamol Gel 5.0mM vs Placebo Salbutamol Gel 10mM vs placebo Total
    Number of subjects
    15 15 15 45
    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
    Subject Age
    Units: years
        arithmetic mean (standard deviation)
    21.7 ± 2.6 22.6 ± 2.2 27.2 ± 8.3 -
    Gender categorical
    Units: Subjects
        Female
    7 6 10 23
        Male
    8 9 5 22
    Fitzpatrick Skin Scale
    Fitzpatrick skin type of subjects
    Units: Subjects
        I-
    6 8 4 18
        II-
    8 5 8 21
        III-IV
    1 0 1 2
        V-VI
    0 2 2 4

    End points

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    End points reporting groups
    Reporting group title
    Salbutamol Gel 2.5mM vs placebo
    Reporting group description
    Within patient study, in which an incision on one arm was dosed with Salbutamol Gel 2.5mM and one arm was dosed with placebo.

    Reporting group title
    Salbutamol Gel 5.0mM vs Placebo
    Reporting group description
    Within subject comparison of salbutamol Gel 5.0mM administered to a wound on one arm compared with Placebo Gel administered to the contralateral arm

    Reporting group title
    Salbutamol Gel 10mM vs placebo
    Reporting group description
    Within subject comparison in which Salbutamol Gel 10mM was administered to one arm and placebo gel to the contralateral arm

    Primary: Proportion of patients achieving salbutamol PK <30mg/mL

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    End point title
    Proportion of patients achieving salbutamol PK <30mg/mL [1]
    End point description
    Pharmacokinetic analysis was summarised for each time of the sample time points. These data were used to calculate the Cmax, Tmax, T1/2 and AUC24 hours for the cutaneous route of administration. The proportion of individuals with Salbutamol peak plasma concentration less than 30ng/ml for the 24 hours following gel application at day 0 were also summarised for each dose
    End point type
    Primary
    End point timeframe
    Day 0
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As a pilot safety study, the number and percentage of participants in each dose group with the primary outcome (i.e. Salbutamol peak plasma concentration in the 24 hours following gel administration at day 0 greater than 30ng/ml), are presented but no statistical tests were performed.
    End point values
    Salbutamol Gel 2.5mM vs placebo Salbutamol Gel 5.0mM vs Placebo Salbutamol Gel 10mM vs placebo
    Number of subjects analysed
    15
    15
    15
    Units: Subjects
    15
    15
    15
    No statistical analyses for this end point

    Primary: Proportion of patients achieving salbutamol PK <30mg/mL

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    End point title
    Proportion of patients achieving salbutamol PK <30mg/mL [2]
    End point description
    End point type
    Primary
    End point timeframe
    Day 10- to 11
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As a pilot safety study, the number and percentage of participants in each dose group with the primary outcome (i.e. Salbutamol peak plasma concentration in the 24 hours following gel administration at day 0 greater than 30ng/ml), are presented but no statistical tests were performed.
    End point values
    Salbutamol Gel 2.5mM vs placebo Salbutamol Gel 5.0mM vs Placebo Salbutamol Gel 10mM vs placebo
    Number of subjects analysed
    13
    15
    15
    Units: Subjects
    13
    15
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 Months
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Salbutamol Gel 2.5mM vs placebo
    Reporting group description
    Within patient study, in which an incision on one arm was dosed with Salbutamol Gel 2.5mM and one arm was dosed with placebo.

    Reporting group title
    Salbutamol Gel 5.0mM vs Placebo
    Reporting group description
    Within subject comparison of salbutamol Gel 5.0mM administered to a wound on one arm compared with Placebo Gel administered to the contralateral arm

    Reporting group title
    Salbutamol Gel 10mM vs placebo
    Reporting group description
    Within subject comparison in which Salbutamol Gel 10mM was administered to one arm and placebo gel to the contralateral arm

    Serious adverse events
    Salbutamol Gel 2.5mM vs placebo Salbutamol Gel 5.0mM vs Placebo Salbutamol Gel 10mM vs placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Reproductive system and breast disorders
    Haemorrhagic ovarian cyst
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Salbutamol Gel 2.5mM vs placebo Salbutamol Gel 5.0mM vs Placebo Salbutamol Gel 10mM vs placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 15 (40.00%)
    6 / 15 (40.00%)
    10 / 15 (66.67%)
    Vascular disorders
    Neurogenic shock
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Blister
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    0
    Contusion
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Ankle fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Surgical and medical procedures
    Wisdom teeth removal
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Syncope
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Tooth impacted
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    Reproductive system and breast disorders
    Polycystic ovaries
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
         occurrences all number
    2
    1
    1
    Dermatitis
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    0
    0
    3
    Urticaria
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    0
    Acne
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Foot fracture
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Infected bite
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Viral rash
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Bacterial vaginosis
         subjects affected / exposed
    0 / 15 (0.00%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Conjunctivitis
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Tinea infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Tooth abscess
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0

    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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