- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03016221
Local Changes of Skin Characteristics After an Application of a Topical Product With a Warming or Cooling Effect (SRPT)
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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
GR
-
Landquart, GR, Switzerland, CH-7302
- SUPSI
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
local skin perfusion
Time Frame: during one hour post application
|
local skin perfusion will be measured with a laser speckle instrument
|
during one hour post application
|
local skin redness
Time Frame: during one hour post application
|
local skin redness (erythema) will be measured with a chromameter
|
during one hour post application
|
skin surface temperature
Time Frame: during one hour post application
|
skin surface temperature will be measured with thermochrons, infrared thermometer and thermal imaging camera
|
during one hour post application
|
local muscle tissue oxygenation
Time Frame: during one hour post application
|
local muscle tissue oxygenation will be measured with near infrared spectroscopy
|
during one hour post application
|
subjective temperature sensation
Time Frame: during one hour post application
|
subjective temperature sensation will be evaluated with a thermal comfort questionnaire
|
during one hour post application
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
during one hour post application
|
skin redness directly next to the application area
Time Frame: during one hour post application
|
skin redness (erythema) will be measured with a chromameter
|
during one hour post application
|
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
|
during one hour post application
|
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
|
during one hour post application
|
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
|
during one hour post application
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016-01541
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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