Local Changes of Skin Characteristics After an Application of a Topical Product With a Warming or Cooling Effect
NCT ID: NCT03016221
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2017-05-01
2019-12-06
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Axanova hot gel
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.
Axanova hot gel
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 hot gel control
No product application. The contralateral lumbar back side acts as a Axanova hot gel control.
No interventions assigned to this group
Axanova activ gel
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.
Axanova activ gel
Axanova activ gel is a topical product with a revulsive effect. It contains menthol, pine needle oil, orange oil, lemon oil, wintergreen oil, glycosaminoglycans.
Axanova activ gel control
No product application. The contralateral lumbar back side acts as a Axanova activ gel control.
No interventions assigned to this group
Perskindol Dolo Gel
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.
Perskindol Dolo Gel
Perskindol Dolo Gel is a topical product with a warming effect. It contains wintergreen oil, pine needle oil, aromatics, excipients.
Perskindol Dolo Gel control
No product application. The contralateral lumbar back side acts as a Perskindol Dolo Gel control.
No interventions assigned to this group
Perskindol Classic Gel
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.
Perskindol Classic Gel
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 Classic Gel control
No product application. The contralateral lumbar back side acts as a Perskindol Classic Gel control.
No interventions assigned to this group
Perskindol Cool Kühl-Gel
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.
Perskindol Cool Kühl-Gel
Perskindol Cool Kühl-Gel is a topical product with a cooling effect. It contains levomenthol, color E131, aromatics, excipients.
Perskindol Cool Kühl-Gel control
No product application. The contralateral lumbar back side acts as a Perskindol Cool Kühl-Gel control.
No interventions assigned to this group
Dolor-X Hot Gel
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.
Dolor-X Hot Gel
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 Hot Gel control
No product application. The contralateral lumbar back side acts as a Dolor-X Hot Gel control.
No interventions assigned to this group
Dolor-X Classic Gel
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.
Dolor-X Classic Gel
Dolor-X Classic Gel is a revulsive product. It contains water, isopropyl alcohol, menthol, spruce, hyprolose, trometamol, wintergreen oil, excipients.
Dolor-X Classic Gel control
No product application. The contralateral lumbar back side acts as a Dolor-X Classic Gel control.
No interventions assigned to this group
Dolor-X Cool Gel
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.
Dolor-X Cool Gel
Dolor-X Cool Gel is a cooling product. It contains water, isopropyl alcohol, menthol, trometamol, color E131, excipients.
Dolor-X Cool Gel control
No product application. The contralateral lumbar back side acts as a Dolor-X Cool Gel control.
No interventions assigned to this group
Interventions
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Axanova hot gel
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
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
Perskindol Dolo Gel is a topical product with a warming effect. It contains wintergreen oil, pine needle oil, aromatics, excipients.
Perskindol Classic Gel
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
Perskindol Cool Kühl-Gel is a topical product with a cooling effect. It contains levomenthol, color E131, aromatics, excipients.
Dolor-X Hot Gel
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
Dolor-X Classic Gel is a revulsive product. It contains water, isopropyl alcohol, menthol, spruce, hyprolose, trometamol, wintergreen oil, excipients.
Dolor-X Cool Gel
Dolor-X Cool Gel is a cooling product. It contains water, isopropyl alcohol, menthol, trometamol, color E131, excipients.
Eligibility Criteria
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Inclusion Criteria
* no surgery in the region of interest in the last year
* healthy skin conditions in the region of interest
Exclusion Criteria
* 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
18 Years
40 Years
ALL
Yes
Sponsors
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University of Applied Sciences and Arts of Southern Switzerland
OTHER
Responsible Party
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Locations
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SUPSI
Landquart, Kanton Graubünden, Switzerland
Countries
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Other Identifiers
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2016-01541
Identifier Type: -
Identifier Source: org_study_id