None listed
Conditions
Brief summary
The purpose of the study is to test if an experimental topical drug is effective in reducing under-arm perspiration in people who have excessive under-arm perspiration
Interventions
2% or 4% glycopyrrolate applied once daily to each armpit for 4 weeks
Sponsors
Stiefel Laboratories
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 16 years of age or older 2. Diagnosis of primary, axilliary hyperhidrosis of at least 6 months duration 3. Ability and willingness to follow all study procedurs, attend all scheduled visits, and successfully complete the study 4. Sign a written informed consent form
Exclusion criteria
1. Intravenous (IV) or oral glycopyrrolate treatment within 8 weeks prior to study enrollment. 2. Prior axillary use of non prescription/ over-the-counter (OTC antiperspirants containing aluminum chloride (or other metallic salts) within 24 hours of study enrollment. 3. Prior axillary use of prescription antiperspirants containing aluminum chloride (or other metallic salts) within the 4 weeks. 4. Known history of a condition that may cause secondary hyperhidrosis. 5. Known history of a condition that could be exacerbated by the use of anticholinergics. 6. Active infection of the axillae. 7. Prior treatment with botulinum toxin (eg, Botox®) for axillary hyperhidrosis within 1 year. 8. Prior treatment with iontophoresis within 4 weeks. 9. Prior surgical procedure for hyperhidrosis. 10. Treatment with psychotherapeutic agents within the 8 weeks. 11. Treatment with topical or systemic anticholinergics, adrenergic agonists (clonidine), or beta-blockers within 8 weeks. 12. Abnormal blood pressure. 13. Pregnant women, women who are breast feeding, or sexually active women of child bearing potential who are not practicing an acceptable method of birth control.
Outcome results
None listed