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    Clinical Trial Results:
    A monocenter, double-blind, randomized study to assess the kinetic of antiperspirant efficacy of Glycopyrrolate 0.2% and 0.02% versus placebo during 4 days of topical applications on axilla of healthy volunteers.

    Summary
    EudraCT number
    		 2014-001796-31
    Trial protocol
    		 DE  
    Global end of trial date
    16 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jul 2021
    First version publication date
    23 Jul 2021
    Other versions
    Summary report(s)
    		 Summary study report GLYCAD

    Trial information

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    Trial identification
    Sponsor protocol code
    ACR/GLYCAD/1375
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    L’OREAL RESEARCH & INNOVATION
    Sponsor organisation address
    1 Avenue Eugène Schueller, Aulnay-sous-Bois , France, 93600
    Public contact
    NOUVEAU Stéphanie Head of Clinical Platform, L’OREAL RESEARCH & INNOVATION, +33 (0)148 68 91 84, stephanie.nouveau@rd.loreal.com
    Scientific contact
    NOUVEAU Stéphanie Head of Clinical Platform, L’OREAL RESEARCH & INNOVATION, +33 (0)148 68 91 84, stephanie.nouveau@rd.loreal.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
    02 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to assess the kinetic of antiperspirant efficacy of Glycopyrrolate 0.2% and 0.02% versus placebo on the axillae of healthy volunteers, during 4 days of topical applications.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 2014
    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: 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
    		 First subject screened: 15 December 2014 ; First subject randomized: 06 January 2015 : in Germany

    Pre-assignment
    Screening details
    		 Wash out period before the screening (D1 to D21): the subject was asked to wash his axillae twice a day with the unscented soap and to use only the deodorant (without antiperspirant ingredients) provided for the study.

    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
    		 Investigator, Monitor, Data analyst, Assessor, Subject
    Blinding implementation details
    The study was conducted double-blind with individual patient kits for the respective randomization numbers. The analysis was performed in accordance with the statistical analysis methodology established prior to the study unblinding. The authorization to unblind the study was given by L’OREAL RESEARCH after database validation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Glycopyrrolate 0.2% compared to Glycopyrrolate 0.02%
    Arm description
    		 Each subject received Glycopyrrolate 0.2% and Glycopyrrolate 0.02% in a randomized manner during 4 consecutive days on axillae
    Arm type
    		 Experimental

    Investigational medicinal product name
    Glycopyrrolate
    Investigational medicinal product code
    Other name
    (3RS)-3-[(2SR)-(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    0.4 g (400µl) once a day for 4 days by topical application on the investigational areas (axillae) depending on randomization

    Arm title
    		 Glycopyrrolate 0.2% compared to placebo
    Arm description
    		 Each subject received Glycopyrrolate 0.2% or placebo in a randomized manner during 4 consecutive days on axillae
    Arm type
    		 Experimental

    Investigational medicinal product name
    Glycopyrrolate
    Investigational medicinal product code
    t
    Other name
    (3RS)-3-[(2SR)-(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    0.4 g (400µl) once a day for 4 days by topical application on the investigational areas (axillae) depending on randomization

    Investigational medicinal product name
    Vehicle without active
    Investigational medicinal product code
    Other name
    Natrosol, Ethanol, Water
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    0.4 g (400µl) once a day for 4 days by Topical application on the investigational areas (axillae) depending on randomization

    Arm title
    		 Glycopyrrolate 0.02% compared to placebo
    Arm description
    		 Each subject received Glycopyrrolate 0.02% or placebo (vehicle) in a randomized manner during 4 consecutive days on axillae
    Arm type
    		 Experimental

    Investigational medicinal product name
    Glycopyrrolate
    Investigational medicinal product code
    Other name
    (3RS)-3-[(2SR)-(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    0.4 g (400µl) once a day for 4 days by topical application on the investigational areas (axillae) depending on randomization

    Investigational medicinal product name
    Vehicle without active
    Investigational medicinal product code
    Other name
    Natrosol, Ethanol, Water
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    0.4 g (400µl) once a day for 4 days by Topical application on the investigational areas (axillae) depending on randomization

    Number of subjects in period 1
    		Glycopyrrolate 0.2% compared to Glycopyrrolate 0.02% Glycopyrrolate 0.2% compared to placebo Glycopyrrolate 0.02% compared to placebo
    Started
    22
    22
    22
    Completed
    22
    21
    17
    Not completed
    0
    1
    5
         Consent withdrawn by subject
    -
    -
    1
         Protocol deviation
    -
    1
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 66 66
    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)
    		 66 66
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        SUBJECT AGE
    		 0 0
    Age continuous
    The mean age of the 66 adults was 32.7 years (range 18 to 45 years).
    Units: years
        arithmetic mean (full range (min-max))
    		 32.7 (18 to 45) -
    Gender categorical
    there were 31 (47%) women and 35 (53%) men
    Units: Subjects
        Female
    		 31 31
        Male
    		 35 35
    Fitzpatrick phototype
    Units: Subjects
        Fitzpatrick phototype II
    		 7 7
        Fitzpatrick phototype III
    		 59 59

    End points

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    End points reporting groups
    Reporting group title
    Glycopyrrolate 0.2% compared to Glycopyrrolate 0.02%
    Reporting group description
    		 Each subject received Glycopyrrolate 0.2% and Glycopyrrolate 0.02% in a randomized manner during 4 consecutive days on axillae

    Reporting group title
    Glycopyrrolate 0.2% compared to placebo
    Reporting group description
    		 Each subject received Glycopyrrolate 0.2% or placebo in a randomized manner during 4 consecutive days on axillae

    Reporting group title
    Glycopyrrolate 0.02% compared to placebo
    Reporting group description
    		 Each subject received Glycopyrrolate 0.02% or placebo (vehicle) in a randomized manner during 4 consecutive days on axillae

    Primary: log reduction of sweat change from baseline (D22)

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    End point title
    		 log reduction of sweat change from baseline (D22)
    End point description
    End point type
    Primary
    End point timeframe
    The amount of sweat was measured gravimetrically at baseline (D22) before the first application of investigational products, at D23; D24, D25 and on D26 , D27 and D28 after application of products.
    End point values
    		 Glycopyrrolate 0.2% compared to Glycopyrrolate 0.02% Glycopyrrolate 0.2% compared to placebo Glycopyrrolate 0.02% compared to placebo
    Number of subjects analysed
    22
    21
    17
    Units: mg
        number (not applicable)
    22
    21
    17
    Statistical analysis title
    		 ANCOVA
    Comparison groups
    Glycopyrrolate 0.2% compared to placebo v Glycopyrrolate 0.02% compared to placebo v Glycopyrrolate 0.2% compared to Glycopyrrolate 0.02%
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.001 [2]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - two - sided test
    [2] - P-value < 0.001 for 0.2 % Glycopyrolate vs placebo at D26 P-value = 0.178 for 0.02 % Glycopyrolate vs placebo at D26

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The obligation to report Adverse Event starts with the enrolment of the subject into the study and continues throughout the whole study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 not applicable
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Glycopyrrolate 0.2% compared to Glycopyrrolate 0.02%
    Reporting group description
    		 Each subject received 2 different compounds Glycopyrrolate 0.2% compared to Glycopyrrolate 0.02%, according to the randomization on the investigational site on the left and right axilla during 4 consecutive days .

    Serious adverse events
    		 Glycopyrrolate 0.2% compared to Glycopyrrolate 0.02%
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Glycopyrrolate 0.2% compared to Glycopyrrolate 0.02%
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 22 (9.09%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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