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HealthySRPTNCT03016221

Local Changes of Skin Characteristics After an Application of a Topical Product With a Warming or Cooling Effect

A study testing Axanova hot gel, Axanova activ gel and Perskindol Dolo Gel in people with Healthy, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.

Completed

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

Official record
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Trial summary

The use of topical over-the-counter (OTC) products with a warming or cooling effect is widespread in the fields of sport, physiotherapy and in private households. Advertisements for such products promise pain relief when suffering from musculoskeletal disorders such as muscle tension, rheumatism or acute injuries… Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Axanova hot gel, Axanova activ gel and Perskindol Dolo Gel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteSwitzerland
Study dates
1 May 2017to 6 Dec 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • no existing musculoskeletal disorders in the region of interest
  • no surgery in the region of interest in the last year
  • healthy skin conditions in the region of interest

Who cannot join

  • fear of treatment
  • regular intake of drugs, excluding contraceptives
  • metal implants in the region between C7 and sacrum, including hip joints
  • lack of epicritic and protopathic skin sensitivity
  • renal insufficiency
  • bronchial asthma
Show all 9Show fewer
  • pregnancy/lactation
  • type 1 or 2 diabetes mellitus
  • polyneuropathy

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • SUPSI

    Landquart, Kanton Graubünden, CH-7302

Other trials in Switzerland

About this study

Official title: Local Changes of Skin Characteristics During and After an Application of a Topical Product With a Warming or Cooling Effect - a Randomized, Controlled Clinical Trial

The use of topical over-the-counter (OTC) products with a warming or cooling effect is widespread in the fields of sport, physiotherapy and in private households. Advertisements for such products promise pain relief when suffering from musculoskeletal disorders such as muscle tension, rheumatism or acute injuries, e.g. sprains. In literature, there are only little information about the efficacy and the physiological mechanisms of topical warming or cooling products. Therefore, the aim of this study is to investigate the local skin characteristics during and after an application of a topical product with a warming or cooling effect.

Read the detailed description

The use of topical products for local pain relief in chronic or acute musculoskeletal disorders is widely used. Despite the widespread use of these products, there is missing information on the physiological mechanisms and efficacy of topical warming and cooling ointments. Most of the existing literature is about the efficacy of topical non-steroidal anti-inflammatory drug (NSAID)-products on chronic pain in osteoarthritis. Furthermore, one study tested the cooling effect of gels with different menthol concentrations. They found that, regardless of the concentration, the skin temperature was reduced up to one hour post application in the area of application.

The aim of our study is to evaluate the change of skin characteristics after a single application of a warming or cooling topical product on healthy subjects. Outcome parameters include skin perfusion, temperature, skin redness and subjective thermal sensation. We only selected products in form of alcohol based ointments, menthol or wintergreen oil. Sprays and patches were excluded.

The application area is the unilateral lumbar back region, whereas the contralateral side serves as control area. After an acclimatization period, baseline measurements are performed, followed by standardized application of the topical product. The local skin responses are measured in 10 mins time increments up to one hour.

Conditions
Healthy
Being tested
Axanova hot gel, Axanova activ gel, Perskindol Dolo Gel, Perskindol Classic Gel, Perskindol Cool Kühl-Gel
Keywords
local skin responses, hyperemia, thermal sensation, topical warming ointments, topical cooling ointments, skin perfusion, subjective thermal sensation, muscle tissue oxygenation, skin temperature, skin redness, erythema
Medical subject headings
Hyperemia, Erythema

What participants receive

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

  • Axanova hot gelOther

    Axanova hot gel is a topical product with a warming effect. It contains menthol, pine needle oil, wintergreen oil, rosemary oil, eucalyptus oil, incense oil.

  • Axanova activ gelOther

    Axanova activ gel is a topical product with a revulsive effect. It contains menthol, pine needle oil, orange oil, lemon oil, wintergreen oil, glycosaminoglycans.

  • Perskindol Dolo GelOther

    Perskindol Dolo Gel is a topical product with a warming effect. It contains wintergreen oil, pine needle oil, aromatics, excipients.

  • Perskindol Classic GelOther

    Perskindol Classic Gel is a topical product with a revulsive effect. It contains menthol, wintergreen oil, pine needle oil, lemon oil, orange peel oil, lemon bergamot oil, rosemary oil, lavender oil, excipients.

  • Perskindol Cool Kühl-GelOther

    Perskindol Cool Kühl-Gel is a topical product with a cooling effect. It contains levomenthol, color E131, aromatics, excipients.

  • Dolor-X Hot GelOther

    Dolor-X Hot Gel is a topical product with a warming effect. It contains isopropyl alcohol, water, menthol, hyprolose, camphor, trometamol, paprika, wintergreen oil, excipients.

  • Dolor-X Classic GelOther

    Dolor-X Classic Gel is a revulsive product. It contains water, isopropyl alcohol, menthol, spruce, hyprolose, trometamol, wintergreen oil, excipients.

  • Dolor-X Cool GelOther

    Dolor-X Cool Gel is a cooling product. It contains water, isopropyl alcohol, menthol, trometamol, color E131, excipients.

Study groups in NCT03016221
Study groupRoleWhat they receive
Axanova hot gelExperimentalIntervention: Axanova hot gel is a topical product with a warming effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
Receives: Other: Axanova hot gel
Axanova hot gel controlNo interventionNo product application. The contralateral lumbar back side acts as a Axanova hot gel control.
Axanova activ gelExperimentalIntervention: Axanova activ gel is a topical product with a revulsive effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
Receives: Other: Axanova activ gel
Axanova activ gel controlNo interventionNo product application. The contralateral lumbar back side acts as a Axanova activ gel control.
Perskindol Dolo GelExperimentalIntervention: Perskindol Dolo Gel is a topical product with a warming effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
Receives: Other: Perskindol Dolo Gel
Perskindol Dolo Gel controlNo interventionNo product application. The contralateral lumbar back side acts as a Perskindol Dolo Gel control.
Perskindol Classic GelExperimentalIntervention: Perskindol Classic Gel is a topical product with a revulsive effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
Receives: Other: Perskindol Classic Gel
Perskindol Classic Gel controlNo interventionNo product application. The contralateral lumbar back side acts as a Perskindol Classic Gel control.
Perskindol Cool Kühl-GelExperimentalIntervention: Perskindol Cool Kühl-Gel is a topical product with a cooling effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
Receives: Other: Perskindol Cool Kühl-Gel
Perskindol Cool Kühl-Gel controlNo interventionNo product application. The contralateral lumbar back side acts as a Perskindol Cool Kühl-Gel control.
Dolor-X Hot GelExperimentalIntervention: Dolor-X Hot Gel is a topical product with a warming effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
Receives: Other: Dolor-X Hot Gel
Dolor-X Hot Gel controlNo interventionNo product application. The contralateral lumbar back side acts as a Dolor-X Hot Gel control.
Dolor-X Classic GelExperimentalIntervention: Dolor-X Classic Gel is a topical product with a revulsive effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
Receives: Other: Dolor-X Classic Gel
Dolor-X Classic Gel controlNo interventionNo product application. The contralateral lumbar back side acts as a Dolor-X Classic Gel control.
Dolor-X Cool GelExperimentalIntervention: Dolor-X Cool Gel is a topical product with a cooling effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
Receives: Other: Dolor-X Cool Gel
Dolor-X Cool Gel controlNo interventionNo product application. The contralateral lumbar back side acts as a Dolor-X Cool Gel control.

What is being measured

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

  1. Local Skin Perfusion

    Local skin perfusion was measured with laser speckle contrast imaging (LSCI). The LSCI system uses arbitrary units to express the mean flux in the specified regions of interest which is related to the concentration of circulating erythrocytes in the tissue sample volume, scaled from blue (low perfusion) to red (high perfusion).

    Measured: during 45min post application

  2. Skin Surface Temperature

    skin surface temperature will be measured with thermochrons, infrared thermometer and thermal imaging camera

    Measured: At baseline and during 45 minutes post application

  3. Local Muscle Tissue Oxygenation

    local muscle tissue oxygenation will be measured with near infrared spectroscopy

    Measured: At baseline and during 45 min post application

  4. Subjective Temperature Sensation

    Thermal sensation ("How does this feel like?") was assessed in each skin area according to the ISO 10551 standard using the following 9-point Likert scale: 4 = very hot, 3 = hot, 2 = warm, 1 = slightly warm, 0 = neutral,-1 = slightly cool,-2 = cool,-3 = cold,-4 = very cold.

    Measured: At baseline and during 45 minutes post application

  5. Subjective Thermal Comfort

    Thermal comfort was assessed ("Do you find this. . .?") in each skin area according to the ISO 10551 standard using using a 5-point Likert scale with 0 = comfortable, 1 = slightly uncomfortable, 2 = uncomfortable, 3 = very uncomfortable, 4 = extremely uncomfortable.

    Measured: At baseline and during 45 minutes post application

Timeline

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

  1. First posted10 Jan 2017 (estimated)
  2. Study start1 May 2017
  3. Primary completion6 Dec 2019
  4. Study completion6 Dec 2019

Resources

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 N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03016221
Sponsor's protocol ID
2016-01541
Other IDs
2016
Acronym
SRPT
Status last verified
May 2026
First submitted
4 Jan 2017
Last updated
16 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Versteeg N, Wellauer V, Wittenwiler S, Aerenhouts D, Clarys P, Clijsen R. Short-term cutaneous vasodilatory and thermosensory effects of topical methyl salicylate. Front Physiol. 2024 Apr 19;15:1347196. doi: 10.3389/fphys.2024.1347196. eCollection 2024.

    PubMed 38706945

Questions about this trial

What is this clinical trial studying?

A study testing Axanova hot gel, Axanova activ gel and Perskindol Dolo Gel in people with Healthy, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.

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 3 inclusion and 9 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 16 Jun 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 Switzerland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Local Skin Perfusion (time frame: during 45min post application). The study lists 5 primary outcomes in all. 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 NCT03016221, which also lists 1 linked publication.

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 16 Jun 2026.

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