Heat StressPhase 2/3NCT07482046

Effectiveness of Topical Menthol as A Cooling Method During Exercise in A Recreational Runner Population

A Phase 2/3 study testing Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%. in people with Heat Stress and Athletic Performance, run by Taisho Pharmaceutical Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The goal of this clinical trial is to evaluate the effectiveness of topical menthol as a cooling method during exercise in a hot air environment in healthy adult recreational runners aged 18 to 45 years. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Heat Stress, Athletic Performance
What is being tested?: Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%.
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: 1 siteIndonesia
Study dates: 30 May 2023to 31 Dec 2023
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Adults, 18 - 45 years old
Have a personal best 10-kilometer run time of under one hour (which will be confirmed during the screening of prospective Subjects through history taking) in the last 6 months.
Doing running training at least 3 times/week for the past 1 year
Have a level of heart-lung endurance or VO2max that is at least included in the average criteria (known through examination: Bleep test)
Meets Subject screening criteria by answering "No" to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) questionnaire.
Have normal resting ECG and normal GDS results on screening of prospective Subjects.
At the time of the study, the body temperature was within the normal range

Who cannot join

Pregnant and/or breastfeeding women
Have had a musculoskeletal injury in the last three months and still have symptoms or complaints
Are experiencing acute infectious disorders, such as gastrointestinal, respiratory infections
During treatment for chronic diseases (e.g. high blood pressure or hypertension, diabetes or diabetes mellitus, heart disease)
Have a history of hypersensitivity or allergy to menthol or skin-applied products (especially gel-based products)
Has a history of cold allergy
Have a positive COVID-19 test result at the time of screening.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Eminence Elite Clinic - Elite Club
Jakarta, DKI Jakarta, 12940

Other trials in Indonesia

About this study

The main questions it aims to answer are:

What is the difference in thermal sensation between the topical menthol gel application and a placebo during exercise? How does the application of topical menthol affect body temperature, heart rate, and physical performance compared to a placebo? Researchers will compare a 4% Menthol gel to a placebo gel in a cross-over design to see if the menthol gel improves thermal sensation, regulates body temperature, and enhances physical performance and comfort.

Participants will:

Undergo a screening process including a medical history review, physical examination, resting ECG, blood sugar test, and a Bleep fitness test.
Participate in two separate running activities at an athletic field, separated by a wash-out period of 7 days + 1 day.Have the assigned gel (menthol or placebo) applied to their neck, front upper arms, and front upper legs while running (specifically between kilometers 2.5 and 2.8).
Complete pre-run and post-run assessments measuring weight, skin and tympanic temperature, heart rate, vertical jump height, running duration, perceived exertion (RPE), thermal sensation, and comfort.

Conditions: Heat Stress, Athletic Performance
Being tested: Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%., Placebo
Keywords: menthol, topical gel, mid-cooling, thermoregulation, heat stress, thermal sensation, exercise, running, athletic performance
Medical subject headings: Heat Stress Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%.Drug
The test drug, i.e. 4% Menthol gel or placebo, will be applied by rubbing on the neck area, the front side of the upper arm and the front side of the upper leg. The neck area was chosen because there is a carotid artery in the neck area, which is said to have an impact on changes in body temperature in the hypothalamus. In addition, the upper arm and upper leg areas were chosen because they are the extremity areas closest to the core of the body and perform a lot of movement while running. Some journals concluded that the application of cooling methods in the hand and thigh area is effective for cooling methods.
PlaceboOther
Light blue gel where the active ingredient Menthol is replaced by purified water.

Study groups in NCT07482046
Study group	Role	What they receive
Placebo Group	Placebo comparator	Placebo: light blue gel where the active ingredient Menthol is replaced by purified water. Receives: Other: Placebo
Menthol Group	Experimental	Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%. Receives: Drug: Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Thermal Sensation
Assessed using a 7-point thermal sensation scale. The scale ranges from -3 to +3, where -3 represents "cold", 0 represents "neutral", and +3 represents "hot". A higher score indicates a greater sensation of heat.
Measured: Baseline (pre-run), during run (~20 minutes), and immediately post-run (within 5 minutes after running completion).

Secondary outcomes (6)

Change in Rating of Perceived Exertion (RPE)
Assessed using the Borg Rating of Perceived Exertion (RPE) scale. The scale ranges from 6 to 20, where 6 indicates "no exertion at all" and 20 indicates "maximal exertion". Higher scores represent a greater perceived physical effort by the participant.
Measured: Immediately post-run (within 5 minutes after running completion).
Change in Tympanic Temperature
Measured in degrees Celsius (°C) using a tympanic thermometer to evaluate thermoregulation and core body temperature changes in response to the running exercise and cooling intervention
Measured: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Running Duration
Running duration was calculated as the time the subject took to complete a 5-kilometer run (in minutes) using a digital pocket sports stopwatch
Measured: Post-run (within 5 minutes after running completion).
Change in Perceived Comfort
To evaluate perceived comfort, participants used a scale that included the options: "comfortable," "somewhat uncomfortable," "uncomfortable," and "extremely uncomfortable
Measured: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Change in Hydration Status
Hydration status, categorized as "well-hydrated," "mildly dehydrated," or "dehydrated,". Pre run hydration status was assessed by matching urine color to a color chart. Post run hydration status was assessed through percentage body weight (BW) loss
Measured: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Change in Heart Rate
Measured in beats per minute (bpm) was measured using a Polar Heart Rate Monitor to evaluate cardiovascular strain and physical intensity during the running exercise. This will include assessing the mean heart rate and the highest heart rate frequency.
Measured: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 202331 Dec 2023

First posted19 Mar 2026
Study start30 May 2023
Primary completion20 Oct 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Heat StressStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07482046
Sponsor's protocol ID: CTP.Mentol-V004/V/2023
Status last verified: Mar 2026
First submitted: 9 Mar 2026
Last updated: 19 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Stevens CJ, Thoseby B, Sculley DV, Callister R, Taylor L, Dascombe BJ. Running performance and thermal sensation in the heat are improved with menthol mouth rinse but not ice slurry ingestion. Scand J Med Sci Sports. 2016 Oct;26(10):1209-16. doi: 10.1111/sms.12555. Epub 2015 Sep 26.
PubMed 26408395
Hermand E, Collado A, Hue O. Skin Application of 4% Menthol Enhances Running Performance in Hot and Humid Climate. Int J Sports Med. 2020 Mar;41(3):161-167. doi: 10.1055/a-1062-6520. Epub 2020 Jan 5.
PubMed 31902130
Schlader ZJ, Simmons SE, Stannard SR, Mundel T. The independent roles of temperature and thermal perception in the control of human thermoregulatory behavior. Physiol Behav. 2011 May 3;103(2):217-24. doi: 10.1016/j.physbeh.2011.02.002. Epub 2011 Feb 16.
PubMed 21315099
Greenfield AM, Alba BK, Giersch GEW, Seeley AD. Sex differences in thermal sensitivity and perception: Implications for behavioral and autonomic thermoregulation. Physiol Behav. 2023 May 1;263:114126. doi: 10.1016/j.physbeh.2023.114126. Epub 2023 Feb 12.
PubMed 36787810
American College of Sports Medicine; Sawka MN, Burke LM, Eichner ER, Maughan RJ, Montain SJ, Stachenfeld NS. American College of Sports Medicine position stand. Exercise and fluid replacement. Med Sci Sports Exerc. 2007 Feb;39(2):377-90. doi: 10.1249/mss.0b013e31802ca597.
PubMed 17277604
Peel J, John K, Page J, Jeffries O, Heffernan SM, Tallent J, Waldron M. Topical application of isolated menthol and combined menthol-capsaicin creams: Exercise tolerance, thermal perception, pain, attentional focus and thermoregulation in the heat. Eur J Sport Sci. 2023 Oct;23(10):2038-2048. doi: 10.1080/17461391.2023.2211966. Epub 2023 Jun 2.
PubMed 37161852
Vogel RM, Varone N, Clark C, Ramirez K, Ross MLR, Swann C, Stevens CJ. A Menthol-Enhanced "Cooling" Energy Gel Does Not Influence Laboratory Time Trial Performance in Trained Runners. Nutrients. 2023 Jul 29;15(15):3379. doi: 10.3390/nu15153379.
PubMed 37571316
Silva H. Current Knowledge on the Vascular Effects of Menthol. Front Physiol. 2020 Apr 7;11:298. doi: 10.3389/fphys.2020.00298. eCollection 2020.
PubMed 32317987
de Camargo R, Vilaca A, Mota GR, Elsangedy HM, Haile L, Sasaki JE. The Influence of L-menthol on Time Trial Running Performance in Recreational Runners. Res Q Exerc Sport. 2023 Jun;94(2):510-518. doi: 10.1080/02701367.2021.2014049. Epub 2022 Apr 12.
PubMed 35412444
Kenney WL, Wolf ST, Dillon GA, Berry CW, Alexander LM. Temperature regulation during exercise in the heat: Insights for the aging athlete. J Sci Med Sport. 2021 Aug;24(8):739-746. doi: 10.1016/j.jsams.2020.12.007. Epub 2020 Dec 25.
PubMed 33358656
Yoshimura S, Nakamura S, Morimoto T. Changes in neural activity during the combining affect labeling and reappraisal. Neurosci Res. 2023 May;190:51-59. doi: 10.1016/j.neures.2022.12.001. Epub 2022 Dec 5.
PubMed 36473523
Barwood MJ, Gibson OR, Gillis DJ, Jeffries O, Morris NB, Pearce J, Ross ML, Stevens C, Rinaldi K, Kounalakis SN, Riera F, Mundel T, Waldron M, Best R. Menthol as an Ergogenic Aid for the Tokyo 2021 Olympic Games: An Expert-Led Consensus Statement Using the Modified Delphi Method. Sports Med. 2020 Oct;50(10):1709-1727. doi: 10.1007/s40279-020-01313-9.
PubMed 32623642
AlOmar RS, AlShamlan NA, AlAmer NA, Aldulijan F, AlMuhaidib S, Almukhadhib O, Algarni SA, Alshaibani A, Darwish M, Al Shammari M. What are the barriers and facilitators of volunteering among healthcare students during the COVID-19 pandemic? A Saudi-based cross-sectional study. BMJ Open. 2021 Feb 18;11(2):e042910. doi: 10.1136/bmjopen-2020-042910.
PubMed 33602709
Bongers CC, Hopman MT, Eijsvogels TM. Cooling interventions for athletes: An overview of effectiveness, physiological mechanisms, and practical considerations. Temperature (Austin). 2017 Jan 3;4(1):60-78. doi: 10.1080/23328940.2016.1277003. eCollection 2017.
PubMed 28349095
Adams WM, Hosokawa Y, Casa DJ. Body-Cooling Paradigm in Sport: Maximizing Safety and Performance During Competition. J Sport Rehabil. 2016 Dec;25(4):382-394. doi: 10.1123/jsr.2015-0008. Epub 2016 Aug 24.
PubMed 27632890

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Topical Menthol as A Cooling Method During Exercise in A Recreational Runner Population
ClinicalTrials.gov ID: NCT07482046
Acronym / sponsor ID: CTP.Mentol-V004/V/2023
Conditions: Heat Stress, Athletic Performance
Keywords: menthol, topical gel, mid-cooling, thermoregulation, heat stress, thermal sensation, exercise, running
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Taisho Pharmaceutical IndonesiaIndustry (pharma, biotech, devices)
Collaborators: Trisakti University, Atma Jaya Catholic University of Indonesia
Study start: 30 May 2023 (actual)
Primary completion: 20 Oct 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 19 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main questions it aims to answer are:

Participants will:

Undergo a screening process including a medical history review, physical examination, resting ECG, blood sugar test, and a Bleep fitness test.
Participate in two separate running activities at an athletic field, separated by a wash-out period of 7 days + 1 day.Have the assigned gel (menthol or placebo) applied to their neck, front upper arms, and front upper legs while running (specifically between kilometers 2.5 and 2.8).
Complete pre-run and post-run assessments measuring weight, skin and tympanic temperature, heart rate, vertical jump height, running duration, perceived exertion (RPE), thermal sensation, and comfort.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo Group	Placebo comparator	Other: PlaceboPlacebo: light blue gel where the active ingredient Menthol is replaced by purified water.
Menthol Group	Experimental	Drug: Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%.Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Adults, 18 - 45 years old
Have a personal best 10-kilometer run time of under one hour (which will be confirmed during the screening of prospective Subjects through history taking) in the last 6 months.
Doing running training at least 3 times/week for the past 1 year
Have a level of heart-lung endurance or VO2max that is at least included in the average criteria (known through examination: Bleep test)
Meets Subject screening criteria by answering "No" to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) questionnaire.

Key exclusion criteria (7 listed)

Pregnant and/or breastfeeding women
Have had a musculoskeletal injury in the last three months and still have symptoms or complaints
Are experiencing acute infectious disorders, such as gastrointestinal, respiratory infections
During treatment for chronic diseases (e.g. high blood pressure or hypertension, diabetes or diabetes mellitus, heart disease)
Have a history of hypersensitivity or allergy to menthol or skin-applied products (especially gel-based products)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%.The test drug, i.e. 4% Menthol gel or placebo, will be applied by rubbing on the neck area, the front side of the upper arm and the front side of the upper leg. The neck area was chosen because there is a carotid artery in the neck area, which is said to have an impact on changes in body temperature in the hypothalamus. In addition, the upper arm and upper leg areas were chosen because they are the extremity areas closest to the core of the body and perform a lot of movement while running. Some journals concluded that the application of cooling methods in the hand and thigh area is effective for cooling methods.	Drug	Menthol Group
PlaceboLight blue gel where the active ingredient Menthol is replaced by purified water.	Other	Placebo Group

Primary outcome

Change in Thermal Sensation
Time frame: Baseline (pre-run), during run (~20 minutes), and immediately post-run (within 5 minutes after running completion).
Assessed using a 7-point thermal sensation scale. The scale ranges from -3 to +3, where -3 represents "cold", 0 represents "neutral", and +3 represents "hot". A higher score indicates a greater sensation of heat.

6 secondary outcomes

Change in Rating of Perceived Exertion (RPE)
Time frame: Immediately post-run (within 5 minutes after running completion).
Change in Tympanic Temperature
Time frame: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Running Duration
Time frame: Post-run (within 5 minutes after running completion).
Change in Perceived Comfort
Time frame: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Change in Hydration Status
Time frame: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).
Change in Heart Rate
Time frame: Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
Background: PubMed 26408395Stevens CJ, Thoseby B, Sculley DV, Callister R, Taylor L, Dascombe BJ. Running performance and thermal sensation in the heat are improved with menthol mouth rinse but not ice slurry ingestion. Scand J Med Sci Sports. 2016 Oct;26(10):1209-16. doi: 10.1111/sms.12555. Epub 2015 Sep 26.
Background: PubMed 31902130Hermand E, Collado A, Hue O. Skin Application of 4% Menthol Enhances Running Performance in Hot and Humid Climate. Int J Sports Med. 2020 Mar;41(3):161-167. doi: 10.1055/a-1062-6520. Epub 2020 Jan 5.
Background: PubMed 21315099Schlader ZJ, Simmons SE, Stannard SR, Mundel T. The independent roles of temperature and thermal perception in the control of human thermoregulatory behavior. Physiol Behav. 2011 May 3;103(2):217-24. doi: 10.1016/j.physbeh.2011.02.002. Epub 2011 Feb 16.
Background: PubMed 36787810Greenfield AM, Alba BK, Giersch GEW, Seeley AD. Sex differences in thermal sensitivity and perception: Implications for behavioral and autonomic thermoregulation. Physiol Behav. 2023 May 1;263:114126. doi: 10.1016/j.physbeh.2023.114126. Epub 2023 Feb 12.
Background: PubMed 17277604American College of Sports Medicine; Sawka MN, Burke LM, Eichner ER, Maughan RJ, Montain SJ, Stachenfeld NS. American College of Sports Medicine position stand. Exercise and fluid replacement. Med Sci Sports Exerc. 2007 Feb;39(2):377-90. doi: 10.1249/mss.0b013e31802ca597.
Background: PubMed 37161852Peel J, John K, Page J, Jeffries O, Heffernan SM, Tallent J, Waldron M. Topical application of isolated menthol and combined menthol-capsaicin creams: Exercise tolerance, thermal perception, pain, attentional focus and thermoregulation in the heat. Eur J Sport Sci. 2023 Oct;23(10):2038-2048. doi: 10.1080/17461391.2023.2211966. Epub 2023 Jun 2.
Background: PubMed 37571316Vogel RM, Varone N, Clark C, Ramirez K, Ross MLR, Swann C, Stevens CJ. A Menthol-Enhanced "Cooling" Energy Gel Does Not Influence Laboratory Time Trial Performance in Trained Runners. Nutrients. 2023 Jul 29;15(15):3379. doi: 10.3390/nu15153379.
Background: PubMed 32317987Silva H. Current Knowledge on the Vascular Effects of Menthol. Front Physiol. 2020 Apr 7;11:298. doi: 10.3389/fphys.2020.00298. eCollection 2020.
Background: PubMed 35412444de Camargo R, Vilaca A, Mota GR, Elsangedy HM, Haile L, Sasaki JE. The Influence of L-menthol on Time Trial Running Performance in Recreational Runners. Res Q Exerc Sport. 2023 Jun;94(2):510-518. doi: 10.1080/02701367.2021.2014049. Epub 2022 Apr 12.
Background: PubMed 33358656Kenney WL, Wolf ST, Dillon GA, Berry CW, Alexander LM. Temperature regulation during exercise in the heat: Insights for the aging athlete. J Sci Med Sport. 2021 Aug;24(8):739-746. doi: 10.1016/j.jsams.2020.12.007. Epub 2020 Dec 25.
Background: PubMed 36473523Yoshimura S, Nakamura S, Morimoto T. Changes in neural activity during the combining affect labeling and reappraisal. Neurosci Res. 2023 May;190:51-59. doi: 10.1016/j.neures.2022.12.001. Epub 2022 Dec 5.
Background: PubMed 32623642Barwood MJ, Gibson OR, Gillis DJ, Jeffries O, Morris NB, Pearce J, Ross ML, Stevens C, Rinaldi K, Kounalakis SN, Riera F, Mundel T, Waldron M, Best R. Menthol as an Ergogenic Aid for the Tokyo 2021 Olympic Games: An Expert-Led Consensus Statement Using the Modified Delphi Method. Sports Med. 2020 Oct;50(10):1709-1727. doi: 10.1007/s40279-020-01313-9.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Thermal Sensation (time frame: Baseline (pre-run), during run (~20 minutes), and immediately post-run (within 5 minutes after running completion).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07482046, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.