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    Clinical Trial Results:
    A Phase IV, Randomized, Interventional, Study to Assess Subject Treatment Session Perception and Investigator Treatment Experience of Alluzience and Vacuum-Dried Botulinum Neurotoxin Type A for Aesthetic Use

    Summary
    EudraCT number
    		 2021-004748-62
    Trial protocol
    		 DE  
    Global end of trial date
    12 Oct 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Feb 2024
    First version publication date
    02 Feb 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    05PF2005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05277337
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Q-Med AB, part of the Galderma Group
    Sponsor organisation address
    Seminariegatan 21, Uppsala, Sweden, SE-752 28
    Public contact
    Daniel Seisdedos, Q-Med AB, part of the Galderma Group, Daniel.SeisdedosHedman@galderma.com
    Scientific contact
    Daniel Seisdedos, Q-Med AB, part of the Galderma Group, Daniel.SeisdedosHedman@galderma.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
    12 Oct 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Oct 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate time needed to prepare Alluzience and powder BoNT A
    Protection of trial subjects
    No invasive assessments were performed and the study product injections were administered according to the SMPC.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Feb 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
    Germany: 56
    Country: Number of subjects enrolled
    United Kingdom: 94
    Worldwide total number of subjects
    150
    EEA total number of subjects
    56
    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)
    150
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 153 subjects were screened in Germany and the United Kingdom. 3 subjects were screening failures and 150 subjects were randomised in the study.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 150
    Number of subjects completed
    		 150

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 (Alluzience)
    Arm description
    		 Alluzience 0.25 mL single dose was administered as an intramuscular injection,through a syringe and needle at baseline visit (Day 0).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alluzience
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Alluzience is an abobotulinum neurotoxin type A, supplied as a sterile, buffered solution for injection. Each vial contains 125 Speywood units (s.U) in 0.625 mL of solution, i.e., 200 s.U/mL. 10 U/0.05 mL per injection point. In total 50 s.U in 0.25 mL for 5 injection points.

    Arm title
    		 Group 2 (Powder BoNT-A: BOTOX/Vistabel)
    Arm description
    		 Powder BoNT-A 0.5 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Powder BoNT-A: BOTOX/Vistabel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intramuscular use
    Dosage and administration details
    BOTOX®/Vistabel® is a onabotulinum toxin type A, supplied in a sterile, vacuum-dried form. The vial, containing 50 U, is reconstituted with 1.25 mL of sterile, 0.9% sodium chloride before study treatment. 4 U/0.1 mL per injection point. In total 20 U in 0.5 mL for 5 injection points.

    Number of subjects in period 1
    		Group 1 (Alluzience) Group 2 (Powder BoNT-A: BOTOX/Vistabel)
    Started
    99
    51
    Completed
    96
    51
    Not completed
    3
    0
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1 (Alluzience)
    Reporting group description
    		 Alluzience 0.25 mL single dose was administered as an intramuscular injection,through a syringe and needle at baseline visit (Day 0).

    Reporting group title
    Group 2 (Powder BoNT-A: BOTOX/Vistabel)
    Reporting group description
    		 Powder BoNT-A 0.5 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).

    Reporting group values
    		 Group 1 (Alluzience) Group 2 (Powder BoNT-A: BOTOX/Vistabel) Total
    Number of subjects
    		 99 51 150
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 99 51 150
    Age continuous
    Age, Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.9 ± 10.27 44.6 ± 10.91 -
    Gender categorical
    Units: Subjects
        Female
    		 99 51 150
        Male
    		 0 0 0
    Race/Ethnicity
    Units: Subjects
        White
    		 94 49 143
        Black or African American
    		 1 1 2
        Asian
    		 1 1 2
        Other Asian
    		 2 0 2
        Other
    		 1 0 1
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set (FAS) Efficacy Population: The FAS was to include all randomized and treated subjects. FAS will be used for all efficacy evaluations.

    Subject analysis set title
    Per-protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per-protocol (PP) Efficacy Population: The Per Protocol (PP) population was a subset of the subjects in the FAS population who completed the Month 1 visit and had no protocol deviations considered to have a substantial impact on the primary efficacy outcome. The primary efficacy endpoint was to be evaluated using the PP population if the PP population consisted of less than 95% of the FAS population.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Population: The safety population was to include all subjects who were administered study product (i.e., Alluzience or powder BoNT-A). Safety analysis were to be performed based on the Safety population.

    Subject analysis sets values
    		 Full Analysis Set Per-protocol Safety Population
    Number of subjects
    150
    150
    150
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    150
    150
    150
    Age continuous
    Age, Continuous
    Units: years
        arithmetic mean (standard deviation)
    45.4 ± 10.47
    45.4 ± 10.47
    45.4 ± 10.47
    Gender categorical
    Units: Subjects
        Female
    150
    150
    150
        Male
    0
    0
    0
    Race/Ethnicity
    Units: Subjects
        White
    143
    143
    143
        Black or African American
    2
    2
    2
        Asian
    2
    2
    2
        Other Asian
    2
    2
    2
        Other
    1
    1
    1

    End points

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    End points reporting groups
    Reporting group title
    Group 1 (Alluzience)
    Reporting group description
    		 Alluzience 0.25 mL single dose was administered as an intramuscular injection,through a syringe and needle at baseline visit (Day 0).

    Reporting group title
    Group 2 (Powder BoNT-A: BOTOX/Vistabel)
    Reporting group description
    		 Powder BoNT-A 0.5 mL single dose was administered as an intramuscular injection, through a syringe and needle at baseline visit (Day 0).

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full Analysis Set (FAS) Efficacy Population: The FAS was to include all randomized and treated subjects. FAS will be used for all efficacy evaluations.

    Subject analysis set title
    Per-protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per-protocol (PP) Efficacy Population: The Per Protocol (PP) population was a subset of the subjects in the FAS population who completed the Month 1 visit and had no protocol deviations considered to have a substantial impact on the primary efficacy outcome. The primary efficacy endpoint was to be evaluated using the PP population if the PP population consisted of less than 95% of the FAS population.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety Population: The safety population was to include all subjects who were administered study product (i.e., Alluzience or powder BoNT-A). Safety analysis were to be performed based on the Safety population.

    Primary: Time Needed to Prepare Alluzience and Powder BoNT A

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    End point title
    		 Time Needed to Prepare Alluzience and Powder BoNT A
    End point description
    Time to prepare Alluzience and powder BoNT-A for administration was collected for all subjects.
    End point type
    Primary
    End point timeframe
    Baseline (Day 0)
    End point values
    		 Group 1 (Alluzience) Group 2 (Powder BoNT-A: BOTOX/Vistabel)
    Number of subjects analysed
    99 [1]
    51 [2]
    Units: Minutes
        arithmetic mean (standard deviation)
    0.55 ± 0.414
    1.57 ± 0.831
    Notes
    [1] - FAS
    [2] - FAS
    Statistical analysis title
    		 Equality of Variance Test T-Test
    Statistical analysis description
    The average preparation time will be compared between the two groups using a t-test. Equality of variances between groups will be tested and the Satterthwaite approximation will be used if the variances are unequal. If it is not the case, Pooled variances will be used. The difference of preparation time, corresponding 95% confidence intervals based on the test used and p-value will be presented.
    Comparison groups
    Group 1 (Alluzience) v Group 2 (Powder BoNT-A: BOTOX/Vistabel)
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.26
         upper limit
    		 -0.77
    Variability estimate
    Standard deviation
    Dispersion value
    0

    Secondary: Percentage of Participants Injected With Alluzience for Whom the Investigator did NOT Faced Technical Issue/Problems When Using a Ready-to-use Product as Compared to a Product to be Reconstituted

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    End point title
    		 Percentage of Participants Injected With Alluzience for Whom the Investigator did NOT Faced Technical Issue/Problems When Using a Ready-to-use Product as Compared to a Product to be Reconstituted [3]
    End point description
    Percentage of participants injected with Alluzience for whom investigator faced technical issue/problems when using a ready-to-use product as compared to a product to be reconstituted, assessed using answers within each answer option (strongly agree, agree,neither agree nor disagree, disagree and strongly disagree) was reported.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive statistics were used for this end point.
    End point values
    		 Group 1 (Alluzience)
    Number of subjects analysed
    99 [4]
    Units: %
    number (not applicable)
        Strongly Agree
    91.9
        Agree
    8.1
    Notes
    [4] - FAS - Arm 1
    No statistical analyses for this end point

    Secondary: Percentage of Participants Injected With Powder Bont-A for WhomInvestigator Experienced Issues While Reconstitution

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    End point title
    		 Percentage of Participants Injected With Powder Bont-A for WhomInvestigator Experienced Issues While Reconstitution [5]
    End point description
    Percentage of participants injected with Powder Bont-A for whom investigator experienced issues while reconstitution was assessed using a questionnaire (Yes/No). Percentage of participants with answer "Yes" was reported.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive statistics were used for this end point.
    End point values
    		 Group 2 (Powder BoNT-A: BOTOX/Vistabel)
    Number of subjects analysed
    51 [6]
    Units: %
    number (not applicable)
        Yes
    2
        No
    98
    Notes
    [6] - FAS - Arm 2
    No statistical analyses for this end point

    Secondary: Investigator Treatment Session Questionnaire

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    End point title
    		 Investigator Treatment Session Questionnaire [7]
    End point description
    The Investigator Treatment Session Questionnaire was completed by the Treating Investigator after the subject has been treated at Visit 2 (baseline). The questionnaire was only completed for Alluzience treated subjects.
    End point type
    Secondary
    End point timeframe
    Post-treatment at baseline (VIsit 2)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive statistics were used for this end point.
    End point values
    		 Group 1 (Alluzience) Full Analysis Set
    Number of subjects analysed
    99
    150
    Units: %
    99
    99
    Attachments
    		 Investigator Treatment Session Questionnaire
    No statistical analyses for this end point

    Secondary: Usability Questionnaire

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    End point title
    		 Usability Questionnaire
    End point description
    The Usability Questionnaire was completed by the Treating Investigators who have been both reconstituting and administering study product. The questionnaire was completed once per Treating Investigator at the sites and was answered for each treatment separately, i.e. once for Alluzience and once for powder BoNT-A. All subjects planned to be enrolled at the site had completed Visit 2 (baseline) when the questionnaire was completed.
    End point type
    Secondary
    End point timeframe
    After all subjects had been treated at the Investigator's study site.
    End point values
    		 Group 1 (Alluzience) Group 2 (Powder BoNT-A: BOTOX/Vistabel) Full Analysis Set
    Number of subjects analysed
    99
    51
    150 [8]
    Units: %
    0
    0
    0
    Attachments
    		 Usability Questionnaire
    Notes
    [8] - Only one questionnaire collected per Treating Investigator (n=21)
    No statistical analyses for this end point

    Secondary: Subject Treatment Session Questionnaire

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    End point title
    		 Subject Treatment Session Questionnaire
    End point description
    The Subject Treatment Session Questionnaire was completed by all treated subjects after treatment at Visit 2 (baseline). The questionnaire is divided into two treatment-specific sections, one for Alluzience and one for powder BoNT-A.
    End point type
    Secondary
    End point timeframe
    Post-treatment at baseline (Visit 2).
    End point values
    		 Group 1 (Alluzience) Group 2 (Powder BoNT-A: BOTOX/Vistabel) Full Analysis Set
    Number of subjects analysed
    99
    51
    150
    Units: %
    0
    0
    0
    Attachments
    		 Subject Treatment Session Questionnaire
    No statistical analyses for this end point

    Secondary: Global Aesthetic Improvement Scale

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    End point title
    		 Global Aesthetic Improvement Scale [9]
    End point description
    At all post-treatment visits for the Alluzience treated subjects (Group 1), subjects and the Investigator rated the global aesthetic improvement of their GL at rest and at maximum frown, relative to their pre-treatment appearance by using the Global Aesthetic Improvement Scale (GAIS).
    End point type
    Secondary
    End point timeframe
    All post-treatment visits after baseline.
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only descriptive statistics were used for this end point.
    End point values
    		 Group 1 (Alluzience) Full Analysis Set
    Number of subjects analysed
    99
    99
    Units: %
    0
    0
    Attachments
    		 Global Aesthetic Improvement Scale
    No statistical analyses for this end point

    Secondary: Subject Satisfaction Questionnaire

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    End point title
    		 Subject Satisfaction Questionnaire
    End point description
    The Subject Treatment Session Questionnaire was completed by all treated subjects after treatment at Visit 2 (baseline). The questionnaire is divided into two treatment-specific sections, one for Alluzience and one for powder BoNT-A.
    End point type
    Secondary
    End point timeframe
    Post-treatment at baseline (Visit 2).
    End point values
    		 Group 1 (Alluzience) Group 2 (Powder BoNT-A: BOTOX/Vistabel) Full Analysis Set
    Number of subjects analysed
    99
    51
    150
    Units: %
    0
    0
    0
    Attachments
    		 Subject Satisfaction Questionnaire
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from treatment until the end of the participant's participation (upto 6 months). The safety population was to include all participants who were administered study product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Group 1 (Alluzience)
    Reporting group description
    		 -

    Reporting group title
    Group 2 (Powder BoNT-A: BOTOX/Vistabel)
    Reporting group description
    		 -

    Serious adverse events
    		 Group 1 (Alluzience) Group 2 (Powder BoNT-A: BOTOX/Vistabel)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 51 (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
    		 Group 1 (Alluzience) Group 2 (Powder BoNT-A: BOTOX/Vistabel)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 99 (26.26%)
    1 / 51 (1.96%)
    Investigations
    SARS-CoV-2 test positive
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 99 (4.04%)
    0 / 51 (0.00%)
         occurrences all number
    4
    0
    Tension headache
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 51 (0.00%)
         occurrences all number
    2
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    11 / 99 (11.11%)
    0 / 51 (0.00%)
         occurrences all number
    11
    0
    Injection site haematoma
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Injection site pruritus
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    5 / 99 (5.05%)
    1 / 51 (1.96%)
         occurrences all number
    5
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 51 (0.00%)
         occurrences all number
    2
    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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