Clinical trial NCT03016221: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: 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
Lead sponsor: University of Applied Sciences and Arts of Southern Switzerland
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: local skin perfusion
timeFrame: during one hour post application
measure: local skin redness
timeFrame: during one hour post application
measure: skin surface temperature
timeFrame: during one hour post application
measure: local muscle tissue oxygenation
timeFrame: during one hour post application
measure: subjective temperature sensation
timeFrame: during one hour post application
Secondary outcomes:
measure: skin perfusion directly next to the application area
timeFrame: during one hour post application
measure: skin redness directly next to the application area
timeFrame: during one hour post application
measure: skin temperature directly next to the application area
timeFrame: during one hour post application
measure: muscle tissue oxygenation directly next to the application area
timeFrame: during one hour post application
measure: subjective temperature sensation directly next to the application area
timeFrame: during one hour post application
Other outcomes:
Locations:
city: Landquart
country: Switzerland
facility: SUPSI
state: GR
Study officials:
References: