NCT05379283

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

August 29, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

May 11, 2022

Last Update Submit

August 27, 2024

Conditions

Sweat Pore Closure

Keywords

thermoregulation, sweating, exercise

Outcome Measures

Primary Outcomes (1)

  • volume of sweat produced during exercise following topical lidocaine

    Volume of sweat produced during exercise following tipocal lidocaine

    one hour of exercise

Study Arms (2)

lidocaine pretreated skin

EXPERIMENTAL

one arm will be pretreated with lidocaine before exercise in the heat

Drug: LidocaineOther: control

control skin

NO INTERVENTION

the other arm will act as the control condition

Interventions

LidocaineDRUG

effect of lidocaine on sweat production during exercise in the heat

lidocaine pretreated skin
controlOTHER

one arm will be pretreated with topical lidocaine, the other arm will not

lidocaine pretreated skin

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92120-1805, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Michael J Buono

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 18, 2022

Study Start

May 15, 2022

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

August 29, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)