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BTX-A Treatment for Palmar Hyperhidrosis

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ClinicalTrials.gov Identifier: NCT01262339
Recruitment Status : Terminated (low enrollment; principal investigator left sponsoring institution)
First Posted : December 17, 2010
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Collaborators:
Allergan
Mattioli
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Primary Focal Hyperhidrosis of the Hands
Intervention Drug: BTX-A
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Comparator of Hand A Intervention vs Hand B
Hide Arm/Group Description

Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.

BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand

Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Comparator of Hand A Intervention vs Hand B
Hide Arm/Group Description

Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.

BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
2
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis.
Hide Description [Not Specified]
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was closed prematurely as principal investigator left the University of Wisconsin. Insufficient data for outcome measures analysis. Data was not entered into tabular format. Study closed and records archived.
Arm/Group Title Active Comparator: Comparator of Hand A Intervention vs Hand B
Hide Arm/Group Description:
Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Comparator of Hand A Intervention vs Hand B
Hide Arm/Group Description

Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.

BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand

All-Cause Mortality
Comparator of Hand A Intervention vs Hand B
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Comparator of Hand A Intervention vs Hand B
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Comparator of Hand A Intervention vs Hand B
Affected / at Risk (%)
Total   0/2 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dermatology Clinical Trials Administrator
Organization: University of Wisconsin- Madison
Phone: 608-287-2640
EMail: dbock@dermatology.wisc.edu
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01262339     History of Changes
Other Study ID Numbers: H-2009-0193
First Submitted: December 15, 2010
First Posted: December 17, 2010
Results First Submitted: December 4, 2014
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015