E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study will be performed in healthy volunteers |
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E.1.1.1 | Medical condition in easily understood language |
The study will be performed in healthy volunteers |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of this study is to assess the antiperspirant efficacy of glycopyrrolate 2% on the axillae of healthy volunteers, after topical applications and compare to the placebo. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to assess the safety of the different study products |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The prescribing information for Robinul (Glycopyrrolate) in particular
contraindications, warnings and precautions, adverse reactions and drug
interactions are to be considered.
• Men and Female from 18 to 45 years old;
• 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;
• Casual Heart rate 48-76 beats/min; Systolic blood pressure 80-135 mm Hg;
Diastolic blood pressure 60-80 mm Hg;
• Skin type I to III according to the Fitzpatrick classification;
• Body Mass Index (BMI) between 20 – 28
• Experience in sauna use;
• Intact, healthy skin in the investigational areas (axilla);
• Willing and able to fulfil the study requirements and schedule;
• Informed about the study objectives and procedures, and able to understand
them;
• Written informed consent obtained; |
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E.4 | Principal exclusion criteria |
• Female in pregnancy (positive urine pregnancy-test performed at screening,
day 22 before randomization and at D34) or lactation, or without effective
contraception1;
• Symptoms or illnesses which may lead to adverse events resulting from
sauna use (cardiovascular diseases, hypertension, coronary deficiency,
varicose vein, respiratory troubles, claustrophobia, diabetes, tiredness,
glaucoma, thyroid diseases, atopic dermatitis);
• Subject with a perspiration level below 100 mg of sweat per axilla and 20
minute collection time This will be evaluated at D22 before randomization.;
• Dermatological disorders influencing the investigational areas (presence of,
acne, rosacea, sunburn, excess pilosity, eczema, urticaria etc. in the
investigational area.);
• Medical history of skin cancer;
• History of intolerance and/or hypersensitivity reactions to medical adhesives;
• History of allergy, hypersensitivity to any medicinal or cosmetic product,
deodorants or antiperspirants;
• History of allergy or contra-indication to glycopyrrolate or any serious
reaction to one of the components of the investigational products;
• Subject with neuromuscular or auto-immune disease 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;
• Having used within the 8 past weeks before the inclusion diazepam and
verapamil, glycopyrrolate and related compounds such as botulinum toxin or
having planned to use these treatments during the study;
• Having used within the 4 past weeks before inclusion any topical or systemic
treatment, drug (anti-inflammatory drugs, corticoids, retinoids, …) or
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;
• Any physical treatment (like laser or electric epilation) under the arm within
the last 6 months, or having planned to use these treatment during the study;
• Having planned U.V. exposure of the investigational areas (sunlight or
sunbeds) during the study;
• Having planned to perform intensive sport (> 5 hours per week) from D0 to
D34)
• Having planned to practice swimming, sauna or hammam during the
treatment period (Day 22 to Day 34)
• Deprivation of freedom by an administrative or legal decision;
• Unable to be contacted by phone in case of emergency;
• Having participated within the 30 days before inclusion or currently
participating in another clinical study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is to show a significant reduction in sweat
production by the study product in comparison with the contralateral control field treated with placebo. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24, 48 and 72 hours after the last application of products |
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E.5.2 | Secondary end point(s) |
Adverse Events and local intolerances |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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
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The end of the trial is last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |