A monocenter, double-blind, randomized study to assess the antiperspirant efficacy of glycopyrrolate 2% versus Aluminium chlorohydrate 15% 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: EUCTR2012-002807-17-DE
• Lead Sponsor: ’OREAL RECHERCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-16
• Last Update Posted: 24 February 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 90-135 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: at least one sauna visit within the last year;
• 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, D22 before randomization and at D34) or lactation, or without effective contraception;
• 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);
• Subject with a perspiration level below 100 mg of sweat per axilla after 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 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 (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;
• Having used within the 8 past weeks before the inclusion diazepam,verapamil, glycopyrrolate or 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, 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;
• 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;
• 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;
• Having planned U.V. exposure on 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 (D22 to D34)
• 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