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
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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

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.
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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

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 ]

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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

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

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