The study will be performed in healthy volunteers
Conditions
Interventions
Product Name: sodium 2% glycopyrrolate
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: GLYCOPYRRONIUM BROMIDE
CAS Number: 596-51-0
Concentration unit: % (W/V) percent weight/volume
Concen
Sponsors
L’OREAL RECHERCHE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: The secondary objective is to assess the safety of the different study products;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.;Timepoint(s) of evaluation of this end point: 24, 48 and 72 hours after the last application of products | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse Events and local intolerances;Timepoint(s) of evaluation of this end point: Study days 32 to 34 | — |
Countries
Germany
Contacts
Public ContactProject Manager L'Oreal Recherche
L’OREAL RECHERCHE
Outcome results
None listed