Trial Outcomes & Findings for BTX-A Treatment for Palmar Hyperhidrosis (NCT NCT01262339)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

2 participants

Primary outcome timeframe

26 weeks

Results posted on

2015-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BTX-A Treatment for Palmar Hyperhidrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Comparator of Hand A Intervention vs Hand B n=2 Participants 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
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 26 weeks

Population: 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.

Outcome measures

Outcome data not reported

Adverse Events

Comparator of Hand A Intervention vs Hand B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dermatology Clinical Trials Administrator

University of Wisconsin- Madison

Phone: 608-287-2640

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place