CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 12 enrolled
Drug / intervention
Capsaicin +3 morebiological
Likely dose
Capsaicin gel applied from shoulder to wrist and mid-thigh to ankleAI-extracted
Key inclusion· 3
  • Age 19-45 years
  • Cleared for physical activity per 2022 PARQ
  • No self-reported adverse reactions to capsaicin
Key exclusion· 5
  • Outside age range 19-45
  • Not cleared for physical activity via 2022 PARQ
  • Self-reported or observed sensitivity to capsaicin
  • Pregnant or breastfeeding

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05298202
NCT05298202Phase 4Completed

The Influence of Topical Capsaicin on Thermoregulatory and Perceptual Outcomes During Exercise Within the Heat

University of Nebraska·interventional·Posted Mar 28, 2022·Updated Mar 15, 2024

In Brief

A Phase 4 clinical trial evaluating Capsaicin, Control Gel, and 2 other interventions for Acute Exercise and Heat Exposure. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the human thermoregulatory impact of applying a commercially available capsaicin gel to the skin prior to moderate intensity walking under heated conditions. Experimental Visits will consist of 30 min of treadmill walking at a moderate pace (3.5 mph, 5% grade) under hot conditions (38°C, 60%RH) and will be randomized and counterbalanced for capsaicin gel or a hypoallergenic gel (control) application. Gels will be applied to areas commonly exposed during outdoor activity in warm conditions (shoulder to wrist, mid thigh to ankle). Accordingly, participants will wear shorts and a tank top shirt during exercise. Core temperature, skin temperature, galvanic skin response, laser doppler blood flow, and heart rate will be continuously recorded throughout the exercise bout via an integrated analog to digital converter. Sweat will be collected during exercise using commercially available absorbent patches. Thermal sensation will be assessed throughout exercise via the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) thermal sensation likert scale (cold to hot). Lastly, nude body weight will be recorded pre and post exercise for sweat rate determination. The capsaicin and control trials will be separated by a 7-14 day washout period

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedMar 28, 2022
Enrollment StartMay 25, 2022
Primary CompletionOct 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.3 years ago

Interventions

Capsaicinbiological

application of capsaicin gel from shoulder to wrist and mid thigh to ankle

Control Gelbiological

application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle

Exerciseother

treadmill walking 3.5 mph at 5% grade

Hot environmentother

38°C, 60% relative humidity