HealthySRPTNCT03016221
Local Changes of Skin Characteristics After an Application of a Topical Product With a Warming or Cooling Effect
A study testing Axanova hot gel, Axanova activ gel and Perskindol Dolo Gel in people with Healthy, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Axanova hot gel, Axanova activ gel and Perskindol Dolo Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2017to 6 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- pregnancy/lactation
- type 1 or 2 diabetes mellitus
- polyneuropathy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Axanova hot gel, Axanova activ gel, Perskindol Dolo Gel, Perskindol Classic Gel, Perskindol Cool Kühl-Gel
- 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
- Medical subject headings
- Hyperemia, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axanova hot gelOther
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 gelOther
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 GelOther
Perskindol Dolo Gel is a topical product with a warming effect. It contains wintergreen oil, pine needle oil, aromatics, excipients.
Perskindol Classic GelOther
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-GelOther
Perskindol Cool Kühl-Gel is a topical product with a cooling effect. It contains levomenthol, color E131, aromatics, excipients.
Dolor-X Hot GelOther
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 GelOther
Dolor-X Classic Gel is a revulsive product. It contains water, isopropyl alcohol, menthol, spruce, hyprolose, trometamol, wintergreen oil, excipients.
Dolor-X Cool GelOther
Dolor-X Cool Gel is a cooling product. It contains water, isopropyl alcohol, menthol, trometamol, color E131, excipients.
| Study group | Role | What they receive |
|---|---|---|
| Axanova hot gel | Experimental | 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. Receives: Other: Axanova hot gel |
| Axanova hot gel control | No intervention | No product application. The contralateral lumbar back side acts as a Axanova hot gel control. |
| Axanova activ gel | Experimental | 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. Receives: Other: Axanova activ gel |
| Axanova activ gel control | No intervention | No product application. The contralateral lumbar back side acts as a Axanova activ gel control. |
| Perskindol Dolo Gel | Experimental | 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. Receives: Other: Perskindol Dolo Gel |
| Perskindol Dolo Gel control | No intervention | No product application. The contralateral lumbar back side acts as a Perskindol Dolo Gel control. |
| Perskindol Classic Gel | Experimental | 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. Receives: Other: Perskindol Classic Gel |
| Perskindol Classic Gel control | No intervention | No product application. The contralateral lumbar back side acts as a Perskindol Classic Gel control. |
| Perskindol Cool Kühl-Gel | Experimental | 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. Receives: Other: Perskindol Cool Kühl-Gel |
| Perskindol Cool Kühl-Gel control | No intervention | No product application. The contralateral lumbar back side acts as a Perskindol Cool Kühl-Gel control. |
| Dolor-X Hot Gel | Experimental | 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. Receives: Other: Dolor-X Hot Gel |
| Dolor-X Hot Gel control | No intervention | No product application. The contralateral lumbar back side acts as a Dolor-X Hot Gel control. |
| Dolor-X Classic Gel | Experimental | 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. Receives: Other: Dolor-X Classic Gel |
| Dolor-X Classic Gel control | No intervention | No product application. The contralateral lumbar back side acts as a Dolor-X Classic Gel control. |
| Dolor-X Cool Gel | Experimental | 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. Receives: Other: Dolor-X Cool Gel |
| Dolor-X Cool Gel control | No intervention | No product application. The contralateral lumbar back side acts as a Dolor-X Cool Gel control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Skin Perfusion
Local skin perfusion was measured with laser speckle contrast imaging (LSCI). The LSCI system uses arbitrary units to express the mean flux in the specified regions of interest which is related to the concentration of circulating erythrocytes in the tissue sample volume, scaled from blue (low perfusion) to red (high perfusion).
Measured: during 45min post application
Skin Surface Temperature
skin surface temperature will be measured with thermochrons, infrared thermometer and thermal imaging camera
Measured: At baseline and during 45 minutes post application
Local Muscle Tissue Oxygenation
local muscle tissue oxygenation will be measured with near infrared spectroscopy
Measured: At baseline and during 45 min post application
Subjective Temperature Sensation
Thermal sensation ("How does this feel like?") was assessed in each skin area according to the ISO 10551 standard using the following 9-point Likert scale: 4 = very hot, 3 = hot, 2 = warm, 1 = slightly warm, 0 = neutral,-1 = slightly cool,-2 = cool,-3 = cold,-4 = very cold.
Measured: At baseline and during 45 minutes post application
Subjective Thermal Comfort
Thermal comfort was assessed ("Do you find this. . .?") in each skin area according to the ISO 10551 standard using using a 5-point Likert scale with 0 = comfortable, 1 = slightly uncomfortable, 2 = uncomfortable, 3 = very uncomfortable, 4 = extremely uncomfortable.
Measured: At baseline and during 45 minutes post application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start1 May 2017
- Primary completion6 Dec 2019
- Study completion6 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences and Arts of Southern Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Clijsen, PhD, Principal investigator, University of Applied Sciences and Arts of Southern Switzerland (SUPSI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016221
- Sponsor's protocol ID
- 2016-01541
- Other IDs
- 2016
- Acronym
- SRPT
- Status last verified
- May 2026
- First submitted
- 4 Jan 2017
- Last updated
- 16 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Versteeg N, Wellauer V, Wittenwiler S, Aerenhouts D, Clarys P, Clijsen R. Short-term cutaneous vasodilatory and thermosensory effects of topical methyl salicylate. Front Physiol. 2024 Apr 19;15:1347196. doi: 10.3389/fphys.2024.1347196. eCollection 2024.
PubMed 38706945
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03016221
- Acronym / sponsor ID
- SRPT / 2016-01541
- Conditions
- Healthy
- Keywords
- local skin responses, hyperemia, thermal sensation, topical warming ointments, topical cooling ointments, skin perfusion, subjective thermal sensation, muscle tissue oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Applied Sciences and Arts of Southern SwitzerlandUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 6 Dec 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Posted 16 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Axanova hot gel | Experimental | Other: Axanova hot gelIntervention: 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 intervention | –No product application. The contralateral lumbar back side acts as a Axanova hot gel control. |
| Axanova activ gel | Experimental | Other: Axanova activ gelIntervention: 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 intervention | –No product application. The contralateral lumbar back side acts as a Axanova activ gel control. |
| Perskindol Dolo Gel | Experimental | Other: Perskindol Dolo GelIntervention: 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 intervention | –No product application. The contralateral lumbar back side acts as a Perskindol Dolo Gel control. |
| Perskindol Classic Gel | Experimental | Other: Perskindol Classic GelIntervention: 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 intervention | –No product application. The contralateral lumbar back side acts as a Perskindol Classic Gel control. |
| Perskindol Cool Kühl-Gel | Experimental | Other: Perskindol Cool Kühl-GelIntervention: 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 intervention | –No product application. The contralateral lumbar back side acts as a Perskindol Cool Kühl-Gel control. |
| Dolor-X Hot Gel | Experimental | Other: Dolor-X Hot GelIntervention: 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 intervention | –No product application. The contralateral lumbar back side acts as a Dolor-X Hot Gel control. |
| Dolor-X Classic Gel | Experimental | Other: Dolor-X Classic GelIntervention: 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 intervention | –No product application. The contralateral lumbar back side acts as a Dolor-X Classic Gel control. |
| Dolor-X Cool Gel | Experimental | Other: Dolor-X Cool GelIntervention: 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 intervention | –No product application. The contralateral lumbar back side acts as a Dolor-X Cool Gel control. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axanova hot gelAxanova 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 hot gel |
| Axanova activ gelAxanova activ gel is a topical product with a revulsive effect. It contains menthol, pine needle oil, orange oil, lemon oil, wintergreen oil, glycosaminoglycans. | Other | Axanova activ gel |
| Perskindol Dolo GelPerskindol Dolo Gel is a topical product with a warming effect. It contains wintergreen oil, pine needle oil, aromatics, excipients. | Other | Perskindol Dolo Gel |
| Perskindol Classic GelPerskindol 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 Classic Gel |
| Perskindol Cool Kühl-GelPerskindol Cool Kühl-Gel is a topical product with a cooling effect. It contains levomenthol, color E131, aromatics, excipients. | Other | Perskindol Cool Kühl-Gel |
| Dolor-X Hot GelDolor-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 Hot Gel |
| Dolor-X Classic GelDolor-X Classic Gel is a revulsive product. It contains water, isopropyl alcohol, menthol, spruce, hyprolose, trometamol, wintergreen oil, excipients. | Other | Dolor-X Classic Gel |
| Dolor-X Cool GelDolor-X Cool Gel is a cooling product. It contains water, isopropyl alcohol, menthol, trometamol, color E131, excipients. | Other | Dolor-X Cool Gel |
Primary outcome
Local Skin Perfusion
Time frame: during 45min post application
Local skin perfusion was measured with laser speckle contrast imaging (LSCI). The LSCI system uses arbitrary units to express the mean flux in the specified regions of interest which is related to the concentration of circulating erythrocytes in the tissue sample volume, scaled from blue (low perfusion) to red (high perfusion).
Skin Surface Temperature
Time frame: At baseline and during 45 minutes post application
skin surface temperature will be measured with thermochrons, infrared thermometer and thermal imaging camera
Local Muscle Tissue Oxygenation
Time frame: At baseline and during 45 min post application
local muscle tissue oxygenation will be measured with near infrared spectroscopy
Subjective Temperature Sensation
Time frame: At baseline and during 45 minutes post application
Thermal sensation ("How does this feel like?") was assessed in each skin area according to the ISO 10551 standard using the following 9-point Likert scale: 4 = very hot, 3 = hot, 2 = warm, 1 = slightly warm, 0 = neutral,-1 = slightly cool,-2 = cool,-3 = cold,-4 = very cold.
Subjective Thermal Comfort
Time frame: At baseline and during 45 minutes post application
Thermal comfort was assessed ("Do you find this. . .?") in each skin area according to the ISO 10551 standard using using a 5-point Likert scale with 0 = comfortable, 1 = slightly uncomfortable, 2 = uncomfortable, 3 = very uncomfortable, 4 = extremely uncomfortable.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38706945Versteeg N, Wellauer V, Wittenwiler S, Aerenhouts D, Clarys P, Clijsen R. Short-term cutaneous vasodilatory and thermosensory effects of topical methyl salicylate. Front Physiol. 2024 Apr 19;15:1347196. doi: 10.3389/fphys.2024.1347196. eCollection 2024.
- fullversion of publicationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Clijsen, PhD principal investigator
University of Applied Sciences and Arts of Southern Switzerland (SUPSI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axanova hot gel, Axanova activ gel and Perskindol Dolo Gel in people with Healthy, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Skin Perfusion (time frame: during 45min post application). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03016221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.