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Completed

NCT Number: NCT03016221

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

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.

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Key information

Conditions

Healthy Cardiovascular Diseases Erythema Hyperemia Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SUPSI

Landquart, Kanton Graubünden, CH-7302, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • pregnancy/lactation
  • type 1 or 2 diabetes mellitus
  • polyneuropathy

Treatment and study plan

Axanova hot gel

Other

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 gel

Other

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 Gel

Other

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

Perskindol Classic Gel

Other

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-Gel

Other

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

Dolor-X Hot Gel

Other

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 Gel

Other

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

Dolor-X Cool Gel

Other

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

Primary outcomes

  1. Local Skin Perfusion

    Time frame: during 45min post application

    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).

  2. Skin Surface Temperature

    Time frame: At baseline and during 45 minutes post application

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

  3. Local Muscle Tissue Oxygenation

    Time frame: At baseline and during 45 min post application

    local muscle tissue oxygenation will be measured with near infrared spectroscopy

  4. Subjective Temperature Sensation

    Time frame: At baseline and during 45 minutes post application

    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.

  5. Subjective Thermal Comfort

    Time frame: At baseline and during 45 minutes post application

    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.

Sponsors and collaborators

Lead sponsor

University of Applied Sciences and Arts of Southern Switzerland

Other

Registry information

Official study 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

Acronym: SRPT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2017
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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