BTX-A Treatment for Palmar Hyperhidrosis

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

  Participant Flow

  Hide Participant Flow

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
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

Participant Flow:   Overall Study

	Comparator of Hand A Intervention vs Hand B
STARTED	2
COMPLETED	2
NOT COMPLETED	0

  Baseline Characteristics

  Hide Baseline Characteristics

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
Overall Participants Analyzed; [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

  Show Serious Adverse Events

  Other Adverse Events

  Show Other Adverse Events

  Limitations and Caveats

  Hide Limitations and Caveats

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
No text entered.

  More Information

  Hide More Information

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

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