Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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BTX-A Treatment for Palmar Hyperhidrosis

This study has been terminated.
(low enrollment; principal investigator left sponsoring institution)
Sponsor:
Collaborators:
Allergan
Mattioli
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01262339
First received: December 15, 2010
Last updated: January 13, 2015
Last verified: January 2015
History of Changes
Results First Received: December 4, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Bio-equivalence Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Primary Focal Hyperhidrosis of the Hands
Intervention: Drug: BTX-A

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Comparator of Hand A Intervention vs Hand B

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

Participant Flow:   Overall Study
    Comparator of Hand A Intervention vs Hand B  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Comparator of Hand A Intervention vs Hand B

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

Baseline Measures
    Comparator of Hand A Intervention vs Hand B  
Number of Participants  
[units: participants]
 		  2  
Age  
[units: participants]
 		 
<=18 years     2  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     2  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     2  



  Outcome Measures

1.  Primary:   Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis.   [ Time Frame: 26 weeks ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Dermatology Clinical Trials Administrator
Organization: University of Wisconsin- Madison
phone: 608-287-2640
e-mail: dbock@dermatology.wisc.edu


No publications provided


Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01262339     History of Changes
Other Study ID Numbers: H-2009-0193
Study First Received: December 15, 2010
Results First Received: December 4, 2014
Last Updated: January 13, 2015
Health Authority: United States: Institutional Review Board