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

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

Tracking Information

• First Submitted Date: January 4, 2017
• First Posted Date: January 10, 2017
• Last Update Posted Date: December 13, 2019
• Actual Study Start Date: May 1, 2017
• Actual Primary Completion Date: December 6, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 16, 2017)

• local skin perfusion [ Time Frame: during one hour post application ]
  local skin perfusion will be measured with a laser speckle instrument
• local skin redness [ Time Frame: during one hour post application ]
  local skin redness (erythema) will be measured with a chromameter
• skin surface temperature [ Time Frame: during one hour post application ]
  skin surface temperature will be measured with thermochrons, infrared thermometer and thermal imaging camera
• local muscle tissue oxygenation [ Time Frame: during one hour post application ]
  local muscle tissue oxygenation will be measured with near infrared spectroscopy
• subjective temperature sensation [ Time Frame: during one hour post application ]
  subjective temperature sensation will be evaluated with a thermal comfort questionnaire

Original Primary Outcome Measures (submitted: January 6, 2017)

• local skin perfusion [ Time Frame: during one hour post application ]
  local skin perfusion will be measured with the laser speckle instrument
• local skin redness [ Time Frame: during one hour post application ]
  local skin redness (erythema) will be measured with the chromameter
• skin surface temperature [ Time Frame: during one hour post application ]
  skin surface temperature will be measured with thermochrons, infra-red thermometer and infrared camera
• local muscle tissue oxygenation [ Time Frame: during one hour post application ]
  local muscle tissue oxygenation will be measured with the near infrared spectroscopy
• subjective temperature sensation [ Time Frame: during one hour post application ]
  subjective temperature sensation will be evaluated with the thermal comfort questionnaire

Current Secondary Outcome Measures (submitted: January 16, 2017)

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

Original Secondary Outcome Measures (submitted: January 6, 2017)

• surrounding (outside application area) skin perfusion [ Time Frame: during one hour post application ]
  surrounding skin perfusion will be measured with the laser speckle instrument
• surrounding (outside application area) skin redness [ Time Frame: during one hour post application ]
  surrounding skin redness (erythema) will be measured with the chromameter
• surrounding (outside application area) skin temperature [ Time Frame: during one hour post application ]
  skin surface temperature will be measured with thermochrons, infrared thermometer and infrared camera
• surrounding (outside application area) muscle tissue oxygenation [ Time Frame: during one hour post application ]
  surrounding muscle tissue oxygenation will be measured with the near infrared
• subjective temperature sensation (outside application area) [ Time Frame: during one hour post application ]
  subjective temperature sensation will be evaluated with the thermal comfort

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Local Changes of Skin Characteristics After an Application of a Topical Product With a Warming or Cooling Effect
• 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
• 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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• 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.
• 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.
• Other: Perskindol Dolo Gel
  Perskindol Dolo Gel is a topical product with a warming effect. It contains wintergreen oil, pine needle oil, aromatics, excipients.
• 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.
• Other: Perskindol Cool Kühl-Gel
  Perskindol Cool Kühl-Gel is a topical product with a cooling effect. It contains levomenthol, color E131, aromatics, excipients.
• 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.
• 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.
• Other: Dolor-X Cool Gel
  Dolor-X Cool Gel is a cooling product. It contains water, isopropyl alcohol, menthol, trometamol, color E131, excipients.

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 12, 2019): 90
• Original Estimated Enrollment (submitted: January 6, 2017): 40
• Actual Study Completion Date: December 6, 2019
• Actual Primary Completion Date: December 6, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT03016221
• Other Study ID Numbers: 2016-01541
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of Applied Sciences and Arts of Southern Switzerland
• Study Sponsor: University of Applied Sciences and Arts of Southern Switzerland
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Applied Sciences and Arts of Southern Switzerland
• Verification Date: June 2019