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    Clinical Trial Results:
    A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Lateral Canthal Lines

    Summary
    EudraCT number
    2014-005279-10
    Trial protocol
    GB  
    Global end of trial date
    25 Jan 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Dec 2023
    First version publication date
    28 Dec 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MT10109L-002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03785145
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    IND: 121473
    Sponsors
    Sponsor organisation name
    Medytox Inc
    Sponsor organisation address
    78, Gangni 1-gil, Ochang-eup, Cheongwon-gu, Cheongju-si, Korea, Republic of, 28126
    Public contact
    Young Ryu, Medytox Inc., 82 2-6901-5424,
    Scientific contact
    Gyungjin Heo, Medytox Inc., 82 2-6901-5839, gjheo@medytox.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
    29 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy between MT10109L and placebo for the treatment of lateral canthal Lines (LCL). The total global enrollment (as presented in the "Population of Trial Subjects" below was 235, which included the Intent-To-Treat population. However, all primary and secondary efficacy analyses for EU regulatory endpoints reported here are using the mITT population that included a total of 181 participants (USA -138 ; Russia -9 and; United-Kingdom -34).
    Protection of trial subjects
    The study protocol, all study protocol amendments, written study participant information, informed consent form (ICF), Investigator’s Brochure (IB) and any other relevant documents were reviewed and approved by an independent ethics committee (IEC) or institutional review board (IRB) at each study center. The study was conducted in accordance with the protocol, the ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) and other Guidelines, and applicable laws and regulations. An ICF approved by each study center’s IEC/IRB was signed by the participant or their legally authorized representative and the authorized person obtaining the ICF before the participant was entered in the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Dec 2018
    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
    United Kingdom: 45
    Country: Number of subjects enrolled
    Russian Federation: 23
    Country: Number of subjects enrolled
    United States: 167
    Worldwide total number of subjects
    235
    EEA total number of subjects
    0
    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)
    224
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were screened and recruited at sites in US, UK and Russia. The data described here is for the Intent-to-Treat population. The Intent-to-treat (ITT) population consisted of all randomized participants.

    Pre-assignment
    Screening details
    235 met the inclusion/exclusion criteria and were randomized. 234 participants entered the study and were treated.

    Period 1
    Period 1 title
    Double-blind
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    Randomization and double-blinding were used to minimize bias arising from the assignment of participants to treatment groups and the expectations of participants, investigators, and individuals collecting data.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo was injected into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    6 injection sites. 0.1 ml per injection. Placebo - 0 U per 0.1 ml

    Arm title
    MT10109L
    Arm description
    MT10109L was injected into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1
    Arm type
    Experimental

    Investigational medicinal product name
    MT10109L
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate, Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    6 injection sites. 0.1 ml per injection. MT10109L - 4 U per 0.1 ml. Total = 24 U

    Number of subjects in period 1
    Placebo MT10109L
    Started
    77
    158
    Completed
    68
    145
    Not completed
    9
    13
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    6
    9
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    2
    2
         No injection received
    1
    -
    Period 2
    Period 2 title
    Open-label - Re- Treatment 1
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    MT10109L re-treatment 1 for Placebo arm
    Arm description
    In the open-label part, participants who met a protocol-defined retreatment criteria were allowed up to 2 MT10109L injections.
    Arm type
    Experimental

    Investigational medicinal product name
    MT10109L
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 treatment cycles in the open-label period. 6 injection sites. 0.1 ml per injection. MT10109L - 4 U per 0.1 ml. Total = 24 U per treatment cycle

    Arm title
    MT10109L re-treatment 1 for experimental arm in cycle 1
    Arm description
    Participants who met protocol-defined retreatment criteria were eligible to receive up to 2 additional MT10109L injections during the open-label part.
    Arm type
    Experimental

    Investigational medicinal product name
    MT10109L
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Retreatment cycle in the open-label period. 6 injection sites per treatment. 0.1 ml per injection. MT10109L - 4 U per 0.1 ml. Total = 24 U per treatment cycle.

    Number of subjects in period 2 [1]
    MT10109L re-treatment 1 for Placebo arm MT10109L re-treatment 1 for experimental arm in cycle 1
    Started
    65
    144
    Completed
    61
    130
    Not completed
    4
    14
         Consent withdrawn by subject
    1
    5
         COVID-19, Enrolled in a different study
    2
    3
         Lost to follow-up
    1
    6
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only participants from the previous treatment period who met a protocol-defined re-treatment criteria entered into the next treatment period.
    Period 3
    Period 3 title
    Open-label - Re-Treatment 2
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    MT10109L re-treatment 2 for Placebo arm
    Arm description
    In the open-label part, participants in the placebo arm who met retreatment criteria were allowed up to 2 MT10109L treatments.
    Arm type
    Experimental

    Investigational medicinal product name
    MT10109L
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Retreatment cycle in the open-label period. 6 injection sites per treatment. 0.1 ml per injection. Placebo - 4 U per 0.1 ml. Total = 24 U per treatment cycle

    Arm title
    MT10109L re-treatment 2 for experimental arm
    Arm description
    Participants from the experimental arm of period 1 who met protocol-defined retreatment criteria were eligible to receive up to 2 MT10109L during the open-label part.
    Arm type
    Experimental

    Investigational medicinal product name
    MT10109L
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection, Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Retreatment cycle in the open-label period. 6 injection sites per treatment. 0.1 ml per injection. MT10109L - 4 U per 0.1 ml. Total = 24 U per treatment cycle

    Number of subjects in period 3 [2]
    MT10109L re-treatment 2 for Placebo arm MT10109L re-treatment 2 for experimental arm
    Started
    49
    91
    Completed
    49
    88
    Not completed
    0
    3
         Consent withdrawn by subject
    -
    1
         COVID 19
    -
    1
         Lost to follow-up
    -
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only participants from the previous treatment period who met a protocol-defined re-treatment criteria entered into the next treatment period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo was injected into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1

    Reporting group title
    MT10109L
    Reporting group description
    MT10109L was injected into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1

    Reporting group values
    Placebo MT10109L Total
    Number of subjects
    77 158 235
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    75 149 224
        From 65-84 years
    2 9 11
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    46.1 ± 11.09 46.6 ± 11.43 -
    Gender categorical
    Units: Subjects
        Female
    61 127 188
        Male
    16 31 47
    Subject analysis sets

    Subject analysis set title
    Demographic and other Baseline Characteristics - ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    235 participants were included in the Intent-To-Treat (ITT) population (77 participants in the placebo group and 158 participants in the MT10109L group).

    Subject analysis set title
    Demographic and other Baseline Characteristics - mITT
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    181 participants were included in the modified Intent To Treat (mITT) population (57 participants in the placebo group and 124 participants in the MT10109L group).

    Subject analysis sets values
    Demographic and other Baseline Characteristics - ITT Demographic and other Baseline Characteristics - mITT
    Number of subjects
    235
    181
    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)
    224
    172
        From 65-84 years
    11
    9
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    46.4 ± 11.30
    48.0 ± 10.8
    Gender categorical
    Units: Subjects
        Female
    188
    152
        Male
    47
    29

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo was injected into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1

    Reporting group title
    MT10109L
    Reporting group description
    MT10109L was injected into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1
    Reporting group title
    MT10109L re-treatment 1 for Placebo arm
    Reporting group description
    In the open-label part, participants who met a protocol-defined retreatment criteria were allowed up to 2 MT10109L injections.

    Reporting group title
    MT10109L re-treatment 1 for experimental arm in cycle 1
    Reporting group description
    Participants who met protocol-defined retreatment criteria were eligible to receive up to 2 additional MT10109L injections during the open-label part.
    Reporting group title
    MT10109L re-treatment 2 for Placebo arm
    Reporting group description
    In the open-label part, participants in the placebo arm who met retreatment criteria were allowed up to 2 MT10109L treatments.

    Reporting group title
    MT10109L re-treatment 2 for experimental arm
    Reporting group description
    Participants from the experimental arm of period 1 who met protocol-defined retreatment criteria were eligible to receive up to 2 MT10109L during the open-label part.

    Subject analysis set title
    Demographic and other Baseline Characteristics - ITT
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    235 participants were included in the Intent-To-Treat (ITT) population (77 participants in the placebo group and 158 participants in the MT10109L group).

    Subject analysis set title
    Demographic and other Baseline Characteristics - mITT
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    181 participants were included in the modified Intent To Treat (mITT) population (57 participants in the placebo group and 124 participants in the MT10109L group).

    Primary: Co-Primary: The Percentage of Participants Achieving None or Mild on the FWS According to Investigator Assessment of LCL Severity at Maximum Smile at Day 30 of Treatment Cycle 1

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    End point title
    Co-Primary: The Percentage of Participants Achieving None or Mild on the FWS According to Investigator Assessment of LCL Severity at Maximum Smile at Day 30 of Treatment Cycle 1
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The data presents the percentage of participants who had LCL severity at maximum smile of none or mild based on investigator FWS rating at cycle 1 day 30. FWS is a 4-point grading scale where 0=none, 1=mild, 2=moderate, 3=severe
    End point type
    Primary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L
    Number of subjects analysed
    57
    124
    Units: Participants
    4
    78
    Statistical analysis title
    % of Participants Achieving None or Mild on FWS
    Statistical analysis description
    All primary and secondary efficacy analyses endpoints were carried out using the modified Intent-To-Treat (mITT) population which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. Multiple imputation method was used for missing variables in primary efficacy endpoint. Analyses of the secondary efficacy variables were performed using observed data.
    Comparison groups
    Placebo v MT10109L
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - The equality of the proportions of responders was analyzed using the CMH tests stratified by LCL baseline severity.

    Primary: Primary: The Percentage of Participants Achieving None or Mild on the FWS According to Participant Assessment of LCL Severity at Maximum Smile at Day 30 of Treatment Cycle 1

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    End point title
    Primary: The Percentage of Participants Achieving None or Mild on the FWS According to Participant Assessment of LCL Severity at Maximum Smile at Day 30 of Treatment Cycle 1
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The data here presents the percentage of participants who had LCL severity at maximum smile of none or mild based on participant FWS rating at Cycle 1 Day 30. FWS is 4-point grading scale, where 0=none, 1=mild, 2=moderate, and 3=severe.
    End point type
    Primary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L
    Number of subjects analysed
    57
    124
    Units: Participants
    3
    70
    Statistical analysis title
    % of Participants achieving primary endpoint
    Statistical analysis description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. Multiple imputation method was used for missing variables in primary efficacy endpoint.
    Comparison groups
    Placebo v MT10109L
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - The equality of the proportions of responders was analyzed using the CMH tests stratified by LCL baseline severity.

    Secondary: Secondary 1: The duration of LCL treatment effect estimated as the median time to return to moderate or severe LCL at maximum smile in participants who achieved a rating of none or mild LCL severity at maximum smile at Day 30

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    End point title
    Secondary 1: The duration of LCL treatment effect estimated as the median time to return to moderate or severe LCL at maximum smile in participants who achieved a rating of none or mild LCL severity at maximum smile at Day 30
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The investigator evaluates the participant's LCL severity using a 4-grade FWS scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (i.e., return to moderate or severe LCL severity at maximum smile using the FWS). FWS is a 4-grade scale (0 to 3) where 0 = none and 3 = severe.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L
    Number of subjects analysed
    4
    71
    Units: Days
        median (inter-quartile range (Q1-Q3))
    113.0 (57.0 to 157.0)
    117.5 (85.0 to 158.0)
    No statistical analyses for this end point

    Secondary: Secondary 2: The percentage of participants reporting mostly satisfied/very satisfied on a 5-point scale of very dissatisfied to very satisfied on the FLSQ follow-up version Item 5 for LCL at Day 60

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    End point title
    Secondary 2: The percentage of participants reporting mostly satisfied/very satisfied on a 5-point scale of very dissatisfied to very satisfied on the FLSQ follow-up version Item 5 for LCL at Day 60
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The Satisfaction Question 5, grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.
    End point type
    Secondary
    End point timeframe
    Day 60
    End point values
    Placebo MT10109L
    Number of subjects analysed
    50
    105
    Units: Participants
    1
    81
    No statistical analyses for this end point

    Secondary: Secondary 3 The percentage of responders for investigator assessments of LCL severity at rest using the FWS among participants who were rated at least mild at rest at baseline, where a responder is defined as achieving a ≥ 1-grade improvement at Day 30

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    End point title
    Secondary 3 The percentage of responders for investigator assessments of LCL severity at rest using the FWS among participants who were rated at least mild at rest at baseline, where a responder is defined as achieving a ≥ 1-grade improvement at Day 30
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The percentage of participants who achieved a ≥1-grade improvement from baseline LCL severity at rest based on investigator FWS rating is presented here. FWS is a 4-grade scale (0 to 3) where 0 = none and 3 = severe.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L
    Number of subjects analysed
    54
    109
    Units: Participants
    5
    57
    No statistical analyses for this end point

    Secondary: Secondary 4: The percentage of responders for participant assessments of LCL severity at rest using the FWS among participants who were rated at least mild at rest at baseline, where a responder was defined as achieving a ≥ 1-grade improvement at Day 30

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    End point title
    Secondary 4: The percentage of responders for participant assessments of LCL severity at rest using the FWS among participants who were rated at least mild at rest at baseline, where a responder was defined as achieving a ≥ 1-grade improvement at Day 30
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The percentage of participants who achieved a ≥1-grade improvement from baseline LCL severity at rest based on participants FWS rating is presented here. FWS is a 4-grade scale (0 to 3) where 0 = none and 3 = severe.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L
    Number of subjects analysed
    54
    112
    Units: Participants
    13
    74
    No statistical analyses for this end point

    Secondary: Secondary 5 The percentage of participants with a ≥ 20-point improvement from baseline at Day 30 on the 11-Item Facial Line Outcomes (FLO-11) Questionnaire total score for LCL

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    End point title
    Secondary 5 The percentage of participants with a ≥ 20-point improvement from baseline at Day 30 on the 11-Item Facial Line Outcomes (FLO-11) Questionnaire total score for LCL
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The percentage of participants who achieved a ≥20-point improvement from baseline on the FLSQ impact domain (eg, reported a good improvement of the facial lines negative impact) are presented here.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L
    Number of subjects analysed
    55
    116
    Units: Participants
    8
    75
    No statistical analyses for this end point

    Secondary: Secondary 6: The percentage of participants with a > 4-point improvement from baseline at Day 30 on FLO-11 questionnaire Item 2 for LCL

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    End point title
    Secondary 6: The percentage of participants with a > 4-point improvement from baseline at Day 30 on FLO-11 questionnaire Item 2 for LCL
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The percentage of participants who achieved a ≥4-point improvement from baseline on the FLO-11 questionnaire item 2 for LCL (eg, reported good improvement in the appearance of skin age) is presented here.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L
    Number of subjects analysed
    55
    116
    Units: Participants
    4
    56
    No statistical analyses for this end point

    Secondary: Secondary 7: The percentage of participants with a > 4-point improvement from baseline at Day 30 on FLO-11 questionnaire Item 5 for LCL

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    End point title
    Secondary 7: The percentage of participants with a > 4-point improvement from baseline at Day 30 on FLO-11 questionnaire Item 5 for LCL
    End point description
    All primary and secondary efficacy analyses for EU regulatory endpoints were carried out using the mITT population, which consisted of all randomized participants who had a baseline transformed FLO-11 questionnaire total score of ≤50. The percentage of participants who achieved a ≥4-point improvement from baseline on the FLO-11 questionnaire item 5 for LCL (eg, reported good improvement in attractiveness) is presented here.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    Placebo MT10109L
    Number of subjects analysed
    53
    114
    Units: Participants
    5
    55
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
    Adverse event reporting additional description
    All safety analyses were carried out using the Safety population, defined as pcts who received at least 1 dose of study intervention. All safety analyses were performed with pcts analyzed by their actual treatment or regimen received. Placebo pcts who entered open-label phase (post Day 180) and received study intervention are counted in MT10109L gp
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    MT10109L
    Reporting group description
    MT10109L was injected into the LCL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. Placebo participants who experienced TEAE after receiving MT10109L during open-label phase were counted here.

    Reporting group title
    Placebo
    Reporting group description
    Placebo was injected into the LCL: initial double-blind treatment on Day 1. In the openlabel period (post day 180), up to 2 MT10109L treatments were possible. TEAEs with onset date after the MT10109L treatment were not counted here.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Non-serious adverse events recorded were below the threshold of 5%.
    Serious adverse events
    MT10109L Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 223 (3.14%)
    0 / 76 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory distress
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Exostosis
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Suspected COVID-19
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 223 (0.45%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    MT10109L Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 223 (0.00%)
    0 / 76 (0.00%)

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Feb 2019
    The primary purpose of this protocol amendment was to integrate feedback and recommendations from health authorities and improve clarity of study processes. This amendment is considered substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union.

    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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