Pressure Ulcer PreventionNCT03815240
Comparing the Effects of Three Different Dressings on the Cutaneous Response of Sacral Skin
A study testing No dressing, Mepilex® Border Sacrum and ALLEVYN Life Sacrum in people with Pressure Ulcer Prevention, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Skin functional parameters such as erythema or stratum corneum hydration have been successfully used in PU prevention research. These parameters are able to discriminate effects of different loading intensities and to measure PU preventive device performance. Read more about this study
- Who is it for?
- Ages 65 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer Prevention
- What is being tested?
- No dressing, Mepilex® Border Sacrum and ALLEVYN Life Sacrum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 8 Feb 2019to 23 Jul 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 65 to 80 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy female volunteers
- 65 to 80 years
- Body Mass Index 18.5 to 29.9 kg/m2
- Non-smoker of at least one year (including electronic-cigarettes)
- Informed consent
- Being free of any clinical dermatosis in the investigational area
Show all 10Show fewer
- Intact sacral skin without scars
- Skin phototype I, II, or III (according to Fitzpatrick)
- No regular use of leave-on products on the sacral skin
- Willing and able to fulfil the study requirements
Who cannot join
- Disability to maintain in supine or prone Position
- Acute diseases
- Known hyper-sensibility or allergy to the study product or any of its ingredients
- Extensive UV exposure 4 weeks before study inclusion
- Use of topical treatment on the investigational areas or systemic Treatment within the 4 past weeks (topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, NSIDS etc.) that would interfere with assessment and/or investigational treatments
- Medical history of skin cancer
Show all 9Show fewer
- History of established Diabetes mellitus, cardiac or renal insufficiency, COPD
- Chronic inflammatory skin disorders such as atopic dermatitis, psoriasis, lichen planus
- Participation in another study 4 weeks prior to study start
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effects of Three Different Dressings on the Cutaneous Response to Pressure and Shear of Sacral Skin: an Exploratory Crossover Study
Skin functional parameters such as erythema or stratum corneum hydration have been successfully used in PU prevention research. These parameters are able to discriminate effects of different loading intensities and to measure PU preventive device performance.
The overall aim of this study is to measure the effects of Mepilex® Border Sacrum Dressing on the skin structure and function during mechanical loading compared to (1) no dressing, (2) ALLEVYN Life Sacrum Dressing and (3) Optifoam® Gentle Liquitrap Sacrum Dressing.
Read the detailed description
Pressure ulcers (PUs) are severe and unwanted cutaneous lesions and subcutaneous wounds caused by prolonged skin and underlying soft tissue deformation. In the supine position they predominantly occur near to bony prominences, like at the sacral area. The cornerstone of PU prevention is repositioning, early mobilization and the use of special support surfaces. In addition, empirical evidence suggests that the application of preventive dressings on PU predilection sites helps to prevent PU development.
Skin functional parameters such as erythema or stratum corneum hydration have been successfully used in PU prevention research. These parameters are able to discriminate effects of different loading intensities and to measure PU preventive device performance. Recently it could be shown that there are associations between structural and functional skin changes at the sacral area during loading. The overall aim of this study is to measure the effects of Mepilex® Border Sacrum Dressing on the skin structure and function during mechanical loading compared to no dressing, ALLEVYN Life Sacrum and Optifoam® Gentle Liquitrap Sacrum.
The procedure of one visit will be as follows:
After a skin acclimatization time of 30 minutes baseline measurements and Cyanoacrylate Skin Surface (CSSS)-stripping will be performed. Then a randomization envelope will be opened and the corresponding dressing will be applied or the skin will be left uncovered. The subject will then lie in supine position on a standard hospital mattress for a loading period of 3.5 hours. Every 30 minutes the head of the bed will be elevated to 45° for five minutes. During these five minutes, the participants will be instructed to bend their knees and to drag the feet repeatedly forth and back 10 times in order to simulate shear forces. The whole exercise will be done six times, after 0.5, 1, 1.5, 2, 2.5 and 3 hours. After 3.5 hours loading time in supine position the subjects will move into prone position. The dressing (if present) will be removed and all skin measurements and CSSS-stripping will be conducted again. The subjects will come back for another three times completing the remaining interventions. At the end, each volunteer will have received all three types of dressings once and once no dressing. In between, there are at least 3 weeks to prevent possible carry over effects.
- Conditions
- Pressure Ulcer Prevention
- Being tested
- No dressing, Mepilex® Border Sacrum, ALLEVYN Life Sacrum, Optifoam® Gentle Sacrum
- Keywords
- Pressure Ulcer Prevention, Preventive Dressings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No dressingOther
no dressing at sacrum
Mepilex® Border SacrumOther
adhesive sacrum dressing
ALLEVYN Life SacrumOther
adhesive sacrum dressing
Optifoam® Gentle SacrumOther
adhesive sacrum dressing
| Study group | Role | What they receive |
|---|---|---|
| no dressing (A) | Other | No dressing will be applied at sacrum before 3.5 hours loading period in supine position Receives: Other: No dressing |
| Mepilex (B) | Active comparator | 'Mepilex® Border Sacrum' dressing will be applied at sacrum before 3.5 hours loading period in supine position Receives: Other: Mepilex® Border Sacrum |
| Allevyn (C) | Active comparator | 'ALLEVYN Life Sacrum' dressing will be applied at sacrum before 3.5 hours loading period in supine position Receives: Other: ALLEVYN Life Sacrum |
| Optifaom (D) | Active comparator | 'Optifoam® Gentle Sacrum' Dressing will be applied at sacrum before 3.5 hours loading period in supine position Receives: Other: Optifoam® Gentle Sacrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skin Surface Temperature From Baseline
A skin thermometer based on infrared technique (Courage and Khazaka Electronic GmbH) was used to measure the skin surface temperature at the sacrum
Measured: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Change in Stratum Corneum Hydration (SCH) From Baseline
Corneometer CM 825 (Courage and Khazaka Electronic GmbH) was used to measure the stratum corneum hydration (SCH) at the sacrum in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. The measurement is based on capacitance measurement of a dielectric medium. The change in the dielectric constant due to skin surface hydration by capacitance differences of a precision capacitor is measured.
Measured: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Change in Erythema Index (EI) From Baseline
Mexameter MX18 (Courage and Khazaka Electronic GmbH) was used to measure the Erythema index at the sacrum. This device uses specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin) and presents values from 0 to 999. Lower values represent less redness.
Measured: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Change in Average Roughness (Rz) From Baseline
The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.
Measured: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Change in Arithmetic Average Roughness (Ra) From Baseline
The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.
Measured: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Change in Maximum Roughness (Rmax) From Baseline
The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.
Measured: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Change in Interleukin IL-1alpha Concentration From Baseline
Based on Cyanoacrylate Skin Surface (CSSS)-Stripping, corneocytes was collected in order to analyse changes regarding interleukin IL-1alpha concentrations.
Measured: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Secondary outcomes (3)
Occurence of Sacral Pain
The occurrence of pain (yes/no)
Measured: Captured from baseline until the end of the loading period after 3.5 hours at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Time Until First Reporting of Sacral Pain
Time from baseline until the subject reported pain at sacrum
Measured: Sacral pain was assessed from baseline up until 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Change in Erythema Score From Baseline
Erythema was assessed by visual inspection. A metric scale will be used: 0 = none 1 = mild (slight reddening), 2 = moderate (distinct redness), 3 = severe (strong redness, dark red)
Measured: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start8 Feb 2019
- Primary completion23 Jul 2019
- Study completion23 Jul 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.
- Other trials for Pressure Ulcer PreventionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Jan Kottner, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815240
- Sponsor's protocol ID
- CRC-SP-A-32
- Status last verified
- Apr 2020
- First submitted
- 16 Jan 2019
- Last updated
- 6 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Three Different Dressings on the Cutaneous Response to Pressure and Shear of Sacral Skin: an Exploratory Crossover Study
- ClinicalTrials.gov ID
- NCT03815240
- Acronym / sponsor ID
- CRC-SP-A-32
- Conditions
- Pressure Ulcer Prevention
- Keywords
- Pressure Ulcer Prevention, Preventive Dressings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Posted 6 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Skin functional parameters such as erythema or stratum corneum hydration have been successfully used in PU prevention research. These parameters are able to discriminate effects of different loading intensities and to measure PU preventive device performance.
The overall aim of this study is to measure the effects of Mepilex® Border Sacrum Dressing on the skin structure and function during mechanical loading compared to (1) no dressing, (2) ALLEVYN Life Sacrum Dressing and (3) Optifoam® Gentle Liquitrap Sacrum Dressing.
Detailed description
Pressure ulcers (PUs) are severe and unwanted cutaneous lesions and subcutaneous wounds caused by prolonged skin and underlying soft tissue deformation. In the supine position they predominantly occur near to bony prominences, like at the sacral area. The cornerstone of PU prevention is repositioning, early mobilization and the use of special support surfaces. In addition, empirical evidence suggests that the application of preventive dressings on PU predilection sites helps to prevent PU development.
Skin functional parameters such as erythema or stratum corneum hydration have been successfully used in PU prevention research. These parameters are able to discriminate effects of different loading intensities and to measure PU preventive device performance. Recently it could be shown that there are associations between structural and functional skin changes at the sacral area during loading. The overall aim of this study is to measure the effects of Mepilex® Border Sacrum Dressing on the skin structure and function during mechanical loading compared to no dressing, ALLEVYN Life Sacrum and Optifoam® Gentle Liquitrap Sacrum.
The procedure of one visit will be as follows:
After a skin acclimatization time of 30 minutes baseline measurements and Cyanoacrylate Skin Surface (CSSS)-stripping will be performed. Then a randomization envelope will be opened and the corresponding dressing will be applied or the skin will be left uncovered. The subject will then lie in supine position on a standard hospital mattress for a loading period of 3.5 hours. Every 30 minutes the head of the bed will be elevated to 45° for five minutes. During these five minutes, the participants will be instructed to bend their knees and to drag the feet repeatedly forth and back 10 times in order to simulate shear forces. The whole exercise will be done six times, after 0.5, 1, 1.5, 2, 2.5 and 3 hours. After 3.5 hours loading time in supine position the subjects will move into prone position. The dressing (if present) will be removed and all skin measurements and CSSS-stripping will be conducted again. The subjects will come back for another three times completing the remaining interventions. At the end, each volunteer will have received all three types of dressings once and once no dressing. In between, there are at least 3 weeks to prevent possible carry over effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| no dressing (A) | Other | Other: No dressingNo dressing will be applied at sacrum before 3.5 hours loading period in supine position |
| Mepilex (B) | Active comparator | Other: Mepilex® Border Sacrum'Mepilex® Border Sacrum' dressing will be applied at sacrum before 3.5 hours loading period in supine position |
| Allevyn (C) | Active comparator | Other: ALLEVYN Life Sacrum'ALLEVYN Life Sacrum' dressing will be applied at sacrum before 3.5 hours loading period in supine position |
| Optifaom (D) | Active comparator | Other: Optifoam® Gentle Sacrum'Optifoam® Gentle Sacrum' Dressing will be applied at sacrum before 3.5 hours loading period in supine position |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Healthy female volunteers
- 65 to 80 years
- Body Mass Index 18.5 to 29.9 kg/m2
- Non-smoker of at least one year (including electronic-cigarettes)
- Informed consent
Key exclusion criteria (9 listed)
- Disability to maintain in supine or prone Position
- Acute diseases
- Known hyper-sensibility or allergy to the study product or any of its ingredients
- Extensive UV exposure 4 weeks before study inclusion
- Use of topical treatment on the investigational areas or systemic Treatment within the 4 past weeks (topical hyaluronan, anti-inflammatory drugs, corticoids, retinoids, NSIDS etc.) that would interfere with assessment and/or investigational treatments
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 |
|---|---|---|
| No dressingno dressing at sacrum | Other | no dressing (A) |
| Mepilex® Border Sacrumadhesive sacrum dressing | Other | Mepilex (B) |
| ALLEVYN Life Sacrumadhesive sacrum dressing | Other | Allevyn (C) |
| Optifoam® Gentle Sacrumadhesive sacrum dressing | Other | Optifaom (D) |
Primary outcome
Change in Skin Surface Temperature From Baseline
Time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
A skin thermometer based on infrared technique (Courage and Khazaka Electronic GmbH) was used to measure the skin surface temperature at the sacrum
Change in Stratum Corneum Hydration (SCH) From Baseline
Time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Corneometer CM 825 (Courage and Khazaka Electronic GmbH) was used to measure the stratum corneum hydration (SCH) at the sacrum in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. The measurement is based on capacitance measurement of a dielectric medium. The change in the dielectric constant due to skin surface hydration by capacitance differences of a precision capacitor is measured.
Change in Erythema Index (EI) From Baseline
Time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Mexameter MX18 (Courage and Khazaka Electronic GmbH) was used to measure the Erythema index at the sacrum. This device uses specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin) and presents values from 0 to 999. Lower values represent less redness.
Change in Average Roughness (Rz) From Baseline
Time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.
Change in Arithmetic Average Roughness (Ra) From Baseline
Time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.
Change in Maximum Roughness (Rmax) From Baseline
Time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
The Visioscan VC 98 camera (Courage and Khazaka Electronic GmbH) was used to capture images of the sacrum. The special LED UV light source with diffuser provides sharp, very high resolution images of the skin surface (255 grey levels representing different depths). The grey level distribution allows the calculation of different roughness parameters to quantitatively describe the skin surface.
Change in Interleukin IL-1alpha Concentration From Baseline
Time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Based on Cyanoacrylate Skin Surface (CSSS)-Stripping, corneocytes was collected in order to analyse changes regarding interleukin IL-1alpha concentrations.
3 secondary outcomes
Occurence of Sacral Pain
Time frame: Captured from baseline until the end of the loading period after 3.5 hours at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Time Until First Reporting of Sacral Pain
Time frame: Sacral pain was assessed from baseline up until 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Change in Erythema Score From Baseline
Time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No dressing, Mepilex® Border Sacrum and ALLEVYN Life Sacrum in people with Pressure Ulcer Prevention, run by Charite University, Berlin, Germany at 1 site in Germany.
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 10 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 6 May 2020. 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 Germany. 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 6 May 2020). 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?
Change in Skin Surface Temperature From Baseline (time frame: Change from baseline after 3.5 hours loading period at visit 1 (Day 0), visit 2 (not before 3 weeks after visit 1), visit 3 (not before 3 weeks after visit 2), visit 4 (not before 3 weeks after visit 3).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.