Local Changes of Skin Characteristics After an Application of a Topical Product With a Warming or Cooling Effect
SRPT
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started May 2017
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2017
CompletedFirst Posted
Study publicly available on registry
January 10, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2019
CompletedDecember 13, 2019
June 1, 2019
2.6 years
January 4, 2017
December 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
local skin perfusion
local skin perfusion will be measured with a laser speckle instrument
during one hour post application
local skin redness
local skin redness (erythema) will be measured with a chromameter
during one hour post application
skin surface temperature
skin surface temperature will be measured with thermochrons, infrared thermometer and thermal imaging camera
during one hour post application
local muscle tissue oxygenation
local muscle tissue oxygenation will be measured with near infrared spectroscopy
during one hour post application
subjective temperature sensation
subjective temperature sensation will be evaluated with a thermal comfort questionnaire
during one hour post application
Secondary Outcomes (5)
skin perfusion directly next to the application area
during one hour post application
skin redness directly next to the application area
during one hour post application
skin temperature directly next to the application area
during one hour post application
muscle tissue oxygenation directly next to the application area
during one hour post application
subjective temperature sensation directly next to the application area
during one hour post application
Study Arms (16)
Axanova hot gel
EXPERIMENTALIntervention: 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 control
NO INTERVENTIONNo product application. The contralateral lumbar back side acts as a Axanova hot gel control.
Axanova activ gel
EXPERIMENTALIntervention: 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 control
NO INTERVENTIONNo product application. The contralateral lumbar back side acts as a Axanova activ gel control.
Perskindol Dolo Gel
EXPERIMENTALIntervention: 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 control
NO INTERVENTIONNo product application. The contralateral lumbar back side acts as a Perskindol Dolo Gel control.
Perskindol Classic Gel
EXPERIMENTALIntervention: 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 control
NO INTERVENTIONNo product application. The contralateral lumbar back side acts as a Perskindol Classic Gel control.
Perskindol Cool Kühl-Gel
EXPERIMENTALIntervention: 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 control
NO INTERVENTIONNo product application. The contralateral lumbar back side acts as a Perskindol Cool Kühl-Gel control.
Dolor-X Hot Gel
EXPERIMENTALIntervention: 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 control
NO INTERVENTIONNo product application. The contralateral lumbar back side acts as a Dolor-X Hot Gel control.
Dolor-X Classic Gel
EXPERIMENTALIntervention: 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 control
NO INTERVENTIONNo product application. The contralateral lumbar back side acts as a Dolor-X Classic Gel control.
Dolor-X Cool Gel
EXPERIMENTALIntervention: 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 control
NO INTERVENTIONNo product application. The contralateral lumbar back side acts as a Dolor-X Cool Gel control.
Interventions
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 is a topical product with a revulsive effect. It contains menthol, pine needle oil, orange oil, lemon oil, wintergreen oil, glycosaminoglycans.
Perskindol Dolo Gel is a topical product with a warming effect. It contains wintergreen oil, pine needle oil, aromatics, excipients.
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 is a topical product with a cooling effect. It contains levomenthol, color E131, aromatics, excipients.
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 is a revulsive product. It contains water, isopropyl alcohol, menthol, spruce, hyprolose, trometamol, wintergreen oil, excipients.
Dolor-X Cool Gel is a cooling product. It contains water, isopropyl alcohol, menthol, trometamol, color E131, excipients.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SUPSI
Landquart, Kanton Graubünden, CH-7302, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2017
First Posted
January 10, 2017
Study Start
May 1, 2017
Primary Completion
December 6, 2019
Study Completion
December 6, 2019
Last Updated
December 13, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share