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

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ClinicalTrials.gov Identifier: NCT03016221
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Applied Sciences and Arts of Southern Switzerland

Brief 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, 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.

Condition or disease Intervention/treatment Phase
Healthy Other: Axanova hot gel Other: Axanova activ gel Other: Perskindol Dolo Gel Other: Perskindol Classic Gel Other: Perskindol Cool Kühl-Gel Other: Dolor-X Hot Gel Other: Dolor-X Classic Gel Other: Dolor-X Cool Gel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : December 6, 2019
Actual Study Completion Date : December 6, 2019

Arm Intervention/treatment
Experimental: 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.
Other: 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.

No Intervention: Axanova hot gel control
No product application. The contralateral lumbar back side acts as a Axanova hot gel control.
Experimental: 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.
Other: 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.

No Intervention: Axanova activ gel control
No product application. The contralateral lumbar back side acts as a Axanova activ gel control.
Experimental: 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.
Other: Perskindol Dolo Gel
Perskindol Dolo Gel is a topical product with a warming effect. It contains wintergreen oil, pine needle oil, aromatics, excipients.

No Intervention: Perskindol Dolo Gel control
No product application. The contralateral lumbar back side acts as a Perskindol Dolo Gel control.
Experimental: 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.
Other: 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.

No Intervention: Perskindol Classic Gel control
No product application. The contralateral lumbar back side acts as a Perskindol Classic Gel control.
Experimental: 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.
Other: Perskindol Cool Kühl-Gel
Perskindol Cool Kühl-Gel is a topical product with a cooling effect. It contains levomenthol, color E131, aromatics, excipients.

No Intervention: Perskindol Cool Kühl-Gel control
No product application. The contralateral lumbar back side acts as a Perskindol Cool Kühl-Gel control.
Experimental: 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.
Other: 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.

No Intervention: Dolor-X Hot Gel control
No product application. The contralateral lumbar back side acts as a Dolor-X Hot Gel control.
Experimental: 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.
Other: Dolor-X Classic Gel
Dolor-X Classic Gel is a revulsive product. It contains water, isopropyl alcohol, menthol, spruce, hyprolose, trometamol, wintergreen oil, excipients.

No Intervention: Dolor-X Classic Gel control
No product application. The contralateral lumbar back side acts as a Dolor-X Classic Gel control.
Experimental: 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.
Other: Dolor-X Cool Gel
Dolor-X Cool Gel is a cooling product. It contains water, isopropyl alcohol, menthol, trometamol, color E131, excipients.

No Intervention: Dolor-X Cool Gel control
No product application. The contralateral lumbar back side acts as a Dolor-X Cool Gel control.



Primary Outcome Measures :
  1. local skin perfusion [ Time Frame: during one hour post application ]
    local skin perfusion will be measured with a laser speckle instrument

  2. local skin redness [ Time Frame: during one hour post application ]
    local skin redness (erythema) will be measured with a chromameter

  3. skin surface temperature [ Time Frame: during one hour post application ]
    skin surface temperature will be measured with thermochrons, infrared thermometer and thermal imaging camera

  4. local muscle tissue oxygenation [ Time Frame: during one hour post application ]
    local muscle tissue oxygenation will be measured with near infrared spectroscopy

  5. subjective temperature sensation [ Time Frame: during one hour post application ]
    subjective temperature sensation will be evaluated with a thermal comfort questionnaire


Secondary Outcome Measures :
  1. skin perfusion directly next to the application area [ Time Frame: during one hour post application ]
    skin perfusion will be measured with a laser speckle instrument

  2. skin redness directly next to the application area [ Time Frame: during one hour post application ]
    skin redness (erythema) will be measured with a chromameter

  3. skin temperature directly next to the application area [ Time Frame: during one hour post application ]
    skin surface temperature will be measured with thermochrons, infrared thermometer and thermal imaging camera

  4. muscle tissue oxygenation directly next to the application area [ Time Frame: during one hour post application ]
    muscle tissue oxygenation will be measured with near infrared spectroscopy

  5. subjective temperature sensation directly next to the application area [ Time Frame: during one hour post application ]
    subjective temperature sensation will be evaluated with a thermal comfort questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016221


Locations
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Switzerland
SUPSI
Landquart, GR, Switzerland, CH-7302
Sponsors and Collaborators
University of Applied Sciences and Arts of Southern Switzerland
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Responsible Party: University of Applied Sciences and Arts of Southern Switzerland
ClinicalTrials.gov Identifier: NCT03016221    
Other Study ID Numbers: 2016-01541
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Applied Sciences and Arts of Southern Switzerland:
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