A single-centre, randomised, double-blind, vehicle-controlled, proof-of-concept study of glycopyrrolate in the treatment of primary axillary hyperhidrosis

Completed

• Conditions: Axillary Hyperhidrosis; Skin - Dermatological conditions

• Registration Number: ACTRN12607000581460
• Lead Sponsor: Stiefel Laboratories

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified