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

Healthy Clinical Trial

— SRPT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03016221
• Other study ID #: 2016-01541
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 6, 2019

Study information

• Verified date: June 2019
• Source: University of Applied Sciences and Arts of Southern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 6, 2019
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• 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.
• 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.

Locations

Country	Name	City	State
Switzerland	SUPSI	Landquart	GR

Sponsors (1)

Lead Sponsor	Collaborator
University of Applied Sciences and Arts of Southern Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local skin perfusion	local skin perfusion will be measured with a laser speckle instrument	during one hour post application
Primary	local skin redness	local skin redness (erythema) will be measured with a chromameter	during one hour post application
Primary	skin surface temperature	skin surface temperature will be measured with thermochrons, infrared thermometer and thermal imaging camera	during one hour post application
Primary	local muscle tissue oxygenation	local muscle tissue oxygenation will be measured with near infrared spectroscopy	during one hour post application
Primary	subjective temperature sensation	subjective temperature sensation will be evaluated with a thermal comfort questionnaire	during one hour post application
Secondary	skin perfusion directly next to the application area	skin perfusion will be measured with a laser speckle instrument	during one hour post application
Secondary	skin redness directly next to the application area	skin redness (erythema) will be measured with a chromameter	during one hour post application
Secondary	skin temperature directly next to the application area	skin surface temperature will be measured with thermochrons, infrared thermometer and thermal imaging camera	during one hour post application
Secondary	muscle tissue oxygenation directly next to the application area	muscle tissue oxygenation will be measured with near infrared spectroscopy	during one hour post application
Secondary	subjective temperature sensation directly next to the application area	subjective temperature sensation will be evaluated with a thermal comfort questionnaire	during one hour post application