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    Summary
    EudraCT Number:2014-001796-31
    Sponsor's Protocol Code Number:ACR/GLYCAD/1375
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2014-001796-31
    A.3Full title of the trial
    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.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.
    A.4.1Sponsor's protocol code numberACR/GLYCAD/1375
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorL’OREAL SA
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportL’OREAL SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationL’OREAL RESEARCH & INNOVATION
    B.5.2Functional name of contact pointHead of Clinical Evaluation
    B.5.3 Address:
    B.5.3.1Street AddressAvenue Eugène Schueller 1
    B.5.3.2Town/ cityAulnay-sous-Bois
    B.5.3.3Post code93600
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)148 689479
    B.5.6E-mailbmuller@rd.loreal.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGlycopyrrolate 0.2%
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596-51-0
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGlycopyrrolate 0.02%
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLYCOPYRRONIUM BROMIDE
    D.3.9.1CAS number 596-51-0
    D.3.9.4EV Substance CodeSUB07951MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.02
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCutaneous solution
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The study will be performed in healthy volunteers.
    E.1.1.1Medical condition in easily understood language
    The study will be performed in healthy volunteers.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess:
    • the kinetic of antiperspirant efficacy of Glycopyrrolate 0.2% in comparison to 0.02% on the axillae of healthy volunteers, during 4 days of topical applications.
    • the safety of the different study products.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The prescribing information for Robinul (Glycopyrrolate) in particular contraindications, warnings and precautions, adverse reactions and drug interactions are to be considered.

    1. Male or female aged 18 to 45 years;

    2. Females of childbearing potential willing to undergo urine pregnancy test or post-menopausal (absence of menstruations for at least one year);

    3. The physical examination and medical history must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial;

    4. Casual Heart rate 48-76 beats/min; Systolic blood pressure 90-135 mm Hg; Diastolic blood pressure 60-80 mm Hg;

    5. Skin type I to III according to the Fitzpatrick classification;

    6. Body Mass Index (BMI) between 20 – 28

    7. Experience in sauna use: at least one sauna visit within the last year;

    8. Intact, healthy skin on the investigational areas (axilla);

    9. Willing and able to fulfil the study requirements and schedule;

    10. Informed about the study objectives and procedures, and able to understand them;

    11. Written informed consent obtained.
    E.4Principal exclusion criteria
    Subjects will be excluded from the study if they meet any of the following criteria:
    1. Female in pregnancy (positive urine pregnancy-test performed at screening visit and at D22_Inclusion visit before randomization) or lactation, or without effective contraception2;

    2“sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen with a failure rate of less than 1 % per year when used consistently and correctly: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide; or absence of sexual activity”

    2. Symptoms or illnesses which may lead to adverse events resulting from Glycopyrrolate and sauna use (such as cardiovascular diseases, prolonged QT interval, hypertension, coronary deficiency, varicose vein, respiratory or gastrointestinal troubles, claustrophobia, diabetes, tiredness, glaucoma, thyroid diseases, atopic dermatitis, obstructive disorders of the lower urinary tract);

    3. Subject with a perspiration level below 100 mg of sweat per axilla after 20 minutes collection time. (This will be evaluated at D22 before randomization)

    4. Subject with a perspiration level above 1500 mg of sweat per axilla after 20 minutes collection period. (This will be evaluated at D22 before randomization);

    5. Subject with a difference of perspiration level > 250 mg between the axillae right and left after 20 minutes collection period. (This will be evaluated at D22 before randomization);

    6. Dermatological disorders influencing the investigational areas (presence of acne, rosacea, sunburn, excess pilosity, eczema, urticaria etc. in the investigational area);

    7. Medical history of skin cancer;

    8. History of allergy, hypersensitivity to any medicinal or cosmetic product, deodorants or antiperspirants;

    9. History of allergy or contra-indication to glycopyrrolate or any serious reaction to one of the components of the investigational products;

    10. Subject with neuromuscular or auto-immune disease (including Myasthenia Gravis) or any acute or chronic illness, or any long term concomitant medical condition which may expose the subject if participating in the study or may interfere with the study conduct, from investigator point of view;

    11. Having used within the 8 past weeks before the inclusion diazepam and verapamil, Glycopyrrolate or compounds such as botulinum toxin or having planned to use these treatments during the study;

    12. Having used within the 4 past weeks before inclusion any topical or systemic treatment, drug (anti-inflammatory drugs, corticoids, retinoids), on the investigational areas, that would interfere with the study assessments and/or investigational products, or having planned to use these treatments during the study;

    13. Having used within the 3 past weeks before inclusion any cosmetic on the investigational areas, that would interfere with the study assessments and/or investigational products, or having planned to use these treatments during the study;
    14. Having shaved or depilated axillae within the 3 days before the first application of the treatment (inclusion visit Day 22);

    15. Any physical treatment (like laser or electric depilation) under the arm within the last 6 months, or having planned to use these treatment during the study;

    16. Having planned UV light exposure on the investigational areas (sunlight or sunbeds) during the study;

    17. Having planned to perform intensive sport activities (> 5 hours per week) or heavy physical work during the treatment and evaluation period (from Day 22 to Day 28);

    18. Having planned to practice swimming, sauna or hammam during the treatment and evaluation period (from D22 to D28)

    19. Deprivation of freedom by an administrative or legal decision;

    20. Unable to be contacted by phone in case of emergency;

    21. Having participated within the 30 days before informed consent signature or currently participating in antiperspirant clinical study or another.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is to show a significant difference in the kinetic of antiperspirant efficacy (in terms of reduction in sweat production) of Glycopyrrolate 0.2% and 0.02% in comparison to Placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The amount of sweat will be measured gravimetrically at baseline (D22) before the first application of investigational products, before application at D23, D24 and D25 as well as on D26 (24h after the last application), D27 (48h after the last application) and D28 (72h after the last application).
    E.5.2Secondary end point(s)
    The secondary are to assess:
    • to show a significant difference in the kinetic of antiperspirant efficacy (in terms of reduction in sweat production) of Glycopyrrolate 0.2% in comparison to 0.02%.

    • the safety of the different study products.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The amount of sweat will be measured gravimetrically at baseline (D22) before the first application of investigational products, before application at D23, D24 and D25 as well as on D26 (24h after the last application), D27 (48h after the last application) and D28 (72h after the last application).

    Safety will be assessed by recording Adverse Events, including cutaneous reactions (local intolerance), from the informed consent signature date until the end of the study.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the Trial is last visit of the last subject undergoing the Trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 66
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state66
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    not applicable as only healthy volunteers are included.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-16
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