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NCT05302804 · ClinicalTrials.gov registry record · Phase 4
The Influence of Menthol Gel During Exercise With Heat
A Phase 4 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT05302804: Completed Phase 4 study, sponsored by University of Nebraska.
NCT05302804 is a Phase 4 study that has completed, run by University of Nebraska. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05302804, a Phase 4 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the human thermoregulatory impact of applying a commercially available menthol gel (BioFreeze) 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 BioFreeze 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 BioFreeze and control trials will be separated by a 7-14 day washout period.
Primary Outcome
Laser Doppler measurement of skin blood flow
Interventions
- DRUG Menthol Gel
- DRUG Control Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-05-01 |
| Est. Completion | 2022-10-01 |
| Phase | Phase 4 |
What the finished NCT05302804 record still lists
NCT05302804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Menthol Gel is the first listed.
NCT05302804 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05302804 about?
NCT05302804 is a clinical study titled "The Influence of Menthol Gel During Exercise With Heat". The purpose of this study is to examine the human thermoregulatory impact of applying a commercially available menthol gel (BioFreeze) 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,...
What is the current status of trial NCT05302804?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2022-05-01. Estimated completion is 2022-10-01.
What interventions are being tested in trial NCT05302804?
The interventions under investigation include: Menthol Gel (DRUG), Control Gel (DRUG).
Who is sponsoring clinical trial NCT05302804?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05302804's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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