ClinicalTrials.Veeva
Menu

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

U

University of Applied Sciences and Arts of Southern Switzerland

Status

Completed

Conditions

Healthy

Treatments

Other: Perskindol Classic Gel
Other: Perskindol Cool Kühl-Gel
Other: Axanova activ gel
Other: Dolor-X Classic Gel
Other: Axanova hot gel
Other: Dolor-X Hot Gel
Other: Perskindol Dolo Gel
Other: Dolor-X Cool Gel

Study type

Interventional

Funder types

Other

Identifiers

NCT03016221
2016-01541

Details and patient eligibility

About

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.

Full 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.

Read more

Enrollment

90 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 16 patient groups

Axanova hot gel
Experimental group
Description:
Intervention: 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.
Treatment:
Other: Axanova hot gel
Axanova hot gel control
No Intervention group
Description:
No product application. The contralateral lumbar back side acts as a Axanova hot gel control.
Axanova activ gel
Experimental group
Description:
Intervention: 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.
Treatment:
Other: Axanova activ gel
Axanova activ gel control
No Intervention group
Description:
No product application. The contralateral lumbar back side acts as a Axanova activ gel control.
Perskindol Dolo Gel
Experimental group
Description:
Intervention: 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.
Treatment:
Other: Perskindol Dolo Gel
Perskindol Dolo Gel control
No Intervention group
Description:
No product application. The contralateral lumbar back side acts as a Perskindol Dolo Gel control.
Perskindol Classic Gel
Experimental group
Description:
Intervention: 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.
Treatment:
Other: Perskindol Classic Gel
Perskindol Classic Gel control
No Intervention group
Description:
No product application. The contralateral lumbar back side acts as a Perskindol Classic Gel control.
Perskindol Cool Kühl-Gel
Experimental group
Description:
Intervention: 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.
Treatment:
Other: Perskindol Cool Kühl-Gel
Perskindol Cool Kühl-Gel control
No Intervention group
Description:
No product application. The contralateral lumbar back side acts as a Perskindol Cool Kühl-Gel control.
Dolor-X Hot Gel
Experimental group
Description:
Intervention: 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.
Treatment:
Other: Dolor-X Hot Gel
Dolor-X Hot Gel control
No Intervention group
Description:
No product application. The contralateral lumbar back side acts as a Dolor-X Hot Gel control.
Dolor-X Classic Gel
Experimental group
Description:
Intervention: 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.
Treatment:
Other: Dolor-X Classic Gel
Dolor-X Classic Gel control
No Intervention group
Description:
No product application. The contralateral lumbar back side acts as a Dolor-X Classic Gel control.
Dolor-X Cool Gel
Experimental group
Description:
Intervention: 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.
Treatment:
Other: Dolor-X Cool Gel
Dolor-X Cool Gel control
No Intervention group
Description:
No product application. The contralateral lumbar back side acts as a Dolor-X Cool Gel control.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Research sites

Find research sitesLearn about CTV for professionals

Resources

Contact CTV support

Legal

Privacy NoticeTerms
© Copyright 2026 Veeva Systems