A monocenter, double-blind, randomized study to assess the antiperspirant efficacy of glycopyrrolate 2% versus placebo after topical applications on axilla of healthy volunteers.

• Conditions: The study will be performed in healthy volunteers; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2012-002393-32-DE
• Lead Sponsor: ’OREAL RECHERCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-27
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified