- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05379283
Does Topical Lidocaine Decrease Sweat During Exercise in the Heat?
May 16, 2022 updated by: Michael J. Buono, San Diego State University
Subjects will walk on a treadmill at 3 mph and sweat will be collected from both forearms.
One arm will be pretreated with topical lidocaine, and the other will act as the control.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Subjects will walk on a treadmill at 3 mph and sweat will be collected from both forearms.
One arm will be pretreated with topical lidocaine, and the other will act as the control.
Sweat will be collected via macroducts attached to each arm.
Sweat production on each arm will be compared using t-tests.
Study Type
Interventional
Enrollment (Anticipated)
22
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 33 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: 18-35 years of age -
Exclusion Criteria: pregnant females
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: lidocaine pretreated skin
one arm will be pretreated with lidocaine before exercise in the heat
|
effect of lidocaine on sweat production during exercise in the heat
one arm will be pretreated with topical lidocaine, the other arm will not
|
No Intervention: control skin
the other arm will act as the control condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
volume of sweat produced during exercise following topical lidocaine
Time Frame: one hour of exercise
|
Volume of sweat produced during exercise following tipocal lidocaine
|
one hour of exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 15, 2022
Primary Completion (Anticipated)
May 15, 2023
Study Completion (Anticipated)
May 15, 2023
Study Registration Dates
First Submitted
May 11, 2022
First Submitted That Met QC Criteria
May 16, 2022
First Posted (Actual)
May 18, 2022
Study Record Updates
Last Update Posted (Actual)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 16, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- ENS2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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