Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000581460
Ethics application status
Approved
Date submitted
29/10/2007
Date registered
9/11/2007
Date last updated
29/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A single-centre, randomised, double-blind, vehicle-controlled, proof-of-concept study of glycopyrrolate in the treatment of primary axillary hyperhidrosis
Scientific title
A single-centre, randomised, double-blind, vehicle-controlled, proof-of-concept study of glycopyrrolate in the treatment of primary axillary hyperhidrosis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Axillary Hyperhidrosis 2506 0
Condition category
Condition code
Skin 2602 2602 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2% or 4% glycopyrrolate applied once daily to each armpit for 4 weeks
Intervention code [1] 2233 0
Treatment: Drugs
Comparator / control treatment
Ethanol solution applied once daily to each armpit for 4 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 3512 0
Gravimetric asessment of sweating
Timepoint [1] 3512 0
Baseline then 1, 2, 3, 4 and 6 weeks after commencement of intervention
Primary outcome [2] 3513 0
Hyperhidrosis disease severity scale
Timepoint [2] 3513 0
Baseline then 1, 2, 3, 4 and 6 weks after commencemnt of intervention
Secondary outcome [1] 5860 0
Saftey of intervention by recording vital signs and adverse events
Timepoint [1] 5860 0
Baseline then 1, 2, 3, 4 and 6 weks after commencemnt of intervention
Secondary outcome [2] 5861 0
Bioavailability of glycopyrrolate
Timepoint [2] 5861 0
Baseline then 1, 2, 3, 4 and 6 weks after commencemnt of intervention

Eligibility
Key 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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2751 0
Commercial sector/Industry
Name [1] 2751 0
Stiefel Laboratories
Country [1] 2751 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Stiefel Laboratories
Address
3160 Porter Drive
Palo Alto, CA, 94304
Country
United States of America
Secondary sponsor category [1] 2485 0
Commercial sector/Industry
Name [1] 2485 0
Novotech (Austalia) Pty Ltd
Address [1] 2485 0
Level 3, 19 Harris St
Pyrmont, NSW, 2009
Country [1] 2485 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4668 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 4668 0
Ethics committee country [1] 4668 0
Australia
Date submitted for ethics approval [1] 4668 0
Approval date [1] 4668 0
21/09/2007
Ethics approval number [1] 4668 0
B91/07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28146 0
Address 28146 0
Country 28146 0
Phone 28146 0
Fax 28146 0
Email 28146 0
Contact person for public queries
Name 11303 0
Lysandra Tassone
Address 11303 0
Novotech (Australia) Pty Ltd
Level 1, Suite 35
49 University St
Carlton, Vic, 3053
Country 11303 0
Australia
Phone 11303 0
+61 3 9341 1900
Fax 11303 0
+61 3 9347 6288
Email 11303 0
lysandra.tassone@novotech-cro.com
Contact person for scientific queries
Name 2231 0
Sabra Abraham
Address 2231 0
3160 Porter Drive
Palo Alto, CA, 94304
Country 2231 0
United States of America
Phone 2231 0
+1 650 843 2831
Fax 2231 0
Email 2231 0
sabra.abraham@stiefel.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.