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.

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

• Registration Number: EUCTR2014-001796-31-DE
• Lead Sponsor: ’OREAL SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-16
• Last Update Posted: 14 March 2016

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.

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.
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 66
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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;

2sexually 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 ligh

Study & Design

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