HealthySMARTevansNCT03311191
Quantifying Skin Oxygenation Properties in Normal vs Sun Exposed Skin
An observational study of Healthy and Sun Exposure, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study aims to determine if there are differences in oxygen consumption between chronically sun exposed and less sun exposed skin. This study uses a new imaging device that can detection oxygenation properties skin in a non-invasive manner. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Sun Exposure
- What is being tested?
- Measurement of skin oxygenation and oxygen consumption
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2017to 6 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study is designed to gather data from two different age groups of men and women to evaluate the differences in skin oxygen properties, if any, between chronically sun exposed and less sun exposed skin. This study makes use of an oxygen sensing bandage device that can quantitatively measure both tissue oxygen partial pressure and oxygen consumption rate. Due to its early stage in development, the device has not yet been designed to control for high melanin content of skin. Thus only subjects with lower melanin content (i.e. Fitzpatrick skin types I - IV) will be included in the study. In addition, tattoo markings, scarring or significant natural discolorations can interfere with the imaging results by absorbing blue light and subjects with any of these will be excluded.
Who may be able to join
- Male or female
- Age groups: 20 - 30 and 55 - 65
- Fitzpatrick skin types I, II, III, and IV
Who cannot join
- Fitzpatrick skin types V and above
- Tattoo markings anywhere on the arm(s)
- Significant scarring or discoloration (e.g. birthmarks) on the arm(s)
- Any current injuries, infections or wounds on the arm(s)
- Routinely (4+ doses per week) take high dosages of anti-inflammatory drugs (e.g. aspirin, ibuprofen, corticosteroids), immunosuppressive drugs, or antihistamine medications. However steroid nose drops and/or eye drops are permitted.
- Has taken an anti-inflammatory drug (e.g. aspirin) within the prior 24 hours of the study visit.
Show all 13Show fewer
- Have diabetes that is treated with injectable or oral insulin
- Have any other active or chronic skin problems on the arms
- Are currently participating in another skin care product study at this or any other facility
- Have participated in any type of skin product treatment study within the past 2 weeks
- Have or ever have had dermatographia
- Pregnant women
- Lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This research study aims to determine if there are differences in oxygen consumption between chronically sun exposed and less sun exposed skin. This study uses a new imaging device that can detection oxygenation properties skin in a non-invasive manner.
Read the detailed description
Sun and ultraviolet light exposure has both short term and long term effects on skin. While the short term effects, such as sunburn, are understood, chronic long-term sun exposure can cause changes to the skin that are not well characterized. One particular alteration may be how the skin consumes oxygen, a change that may be linked to biochemical alterations that have been observed in past studies. Measuring skin oxygen consumption has traditionally been difficult as the tools available have not been easy to incorporate into clinical studies. In this study, we overcome this barrier through the use of a new non-invasive oxygen-sensing device that can rapidly measure skin oxygenation properties such as oxygen consumption. This observational study will measure the oxygenation properties of both chronically sun exposed and less sun exposed skin in the predefined groups of both young and older men and women.
- Conditions
- Healthy, Sun Exposure
- Being tested
- Measurement of skin oxygenation and oxygen consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of skin oxygenation and oxygen consumptionDevice
Oxygenation properties will be measured using a transparent paint-on bandage formulation that consists of New-Skin liquid bandage, an oxygen-sensing metallo-porphyrin exhibiting bright red phosphorescence, and the green-fluorescing reference dye fluorescein.
| Study group | Role | What they receive |
|---|---|---|
| Younger Women | Women ages 20-30 who are not pregnant will be painted with oxygen sensing bandage Receives: Device: Measurement of skin oxygenation and oxygen consumption | |
| Younger Men | Men ages 20-30 will be painted with oxygen sensing bandage Receives: Device: Measurement of skin oxygenation and oxygen consumption | |
| Older Women | Women ages 55-65 who are not pregnant will be painted with oxygen sensing bandage Receives: Device: Measurement of skin oxygenation and oxygen consumption | |
| Older Men | Men ages 55-65 will be painted with oxygen sensing bandage Receives: Device: Measurement of skin oxygenation and oxygen consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the relative (sun exposed vs nonexposed) and absolute oxygen properties within an individual and between the two age groups
The skin's partial pressure of oxygen and oxygen consumption rate is measured at 4 different locations on the subjects arms using the oxygen sensing device, where it is expected that that difference between more sun exposed regions and less sun exposed regions will be greater in the population of older adults.
Measured: 20 min estimated per subject
Secondary outcomes (1)
The differences in the relative (sun exposed vs nonexposed) and absolute oxygen properties between the sexes
The skin's partial pressure of oxygen and oxygen consumption rate is measured using the oxygen sensing device and compared between the sexes (arm 1+3 and arm 2+4)
Measured: 20 min estimated per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start17 Jul 2017
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
Why it stopped: Ran out of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Principal investigator, Conor L Evans, Massachusetts General Hospital
- Investigators
- Conor L Evans, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311191
- Sponsor's protocol ID
- 2017P000695
- Acronym
- SMARTevans
- Status last verified
- Aug 2019
- First submitted
- 5 Oct 2017
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study was funded by a research gift from Procter \& Gamble. While the investigator is under no obligation to do so, research results and/or study data may be shared with the company for purposes of future scientific publications and/or research collaborations. However, information shared with the company will not include any identifiers that could be used to link data to individual subjects.
Publications
Koolen PGL, Li Z, Roussakis E, Paul MA, Ibrahim AMS, Matyal R, Huang T, Evans CL, Lin SJ. Oxygen-Sensing Paint-On Bandage: Calibration of a Novel Approach in Tissue Perfusion Assessment. Plast Reconstr Surg. 2017 Jul;140(1):89-96. doi: 10.1097/PRS.0000000000003421.
PubMed 28654595Roussakis E, Li Z, Nowell NH, Nichols AJ, Evans CL. Bright, "Clickable" Porphyrins for the Visualization of Oxygenation under Ambient Light. Angew Chem Int Ed Engl. 2015 Dec 1;54(49):14728-31. doi: 10.1002/anie.201506847. Epub 2015 Oct 29.
PubMed 26510549
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Skin Oxygenation Properties in Normal vs Sun Exposed Skin
- ClinicalTrials.gov ID
- NCT03311191
- Acronym / sponsor ID
- SMARTevans / 2017P000695
- Conditions
- Healthy, Sun Exposure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Ran out of funding
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study aims to determine if there are differences in oxygen consumption between chronically sun exposed and less sun exposed skin. This study uses a new imaging device that can detection oxygenation properties skin in a non-invasive manner.
Detailed description
Sun and ultraviolet light exposure has both short term and long term effects on skin. While the short term effects, such as sunburn, are understood, chronic long-term sun exposure can cause changes to the skin that are not well characterized. One particular alteration may be how the skin consumes oxygen, a change that may be linked to biochemical alterations that have been observed in past studies. Measuring skin oxygen consumption has traditionally been difficult as the tools available have not been easy to incorporate into clinical studies. In this study, we overcome this barrier through the use of a new non-invasive oxygen-sensing device that can rapidly measure skin oxygenation properties such as oxygen consumption. This observational study will measure the oxygenation properties of both chronically sun exposed and less sun exposed skin in the predefined groups of both young and older men and women.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Younger Women | – | Device: Measurement of skin oxygenation and oxygen consumptionWomen ages 20-30 who are not pregnant will be painted with oxygen sensing bandage |
| Younger Men | – | Device: Measurement of skin oxygenation and oxygen consumptionMen ages 20-30 will be painted with oxygen sensing bandage |
| Older Women | – | Device: Measurement of skin oxygenation and oxygen consumptionWomen ages 55-65 who are not pregnant will be painted with oxygen sensing bandage |
| Older Men | – | Device: Measurement of skin oxygenation and oxygen consumptionMen ages 55-65 will be painted with oxygen sensing bandage |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study is designed to gather data from two different age groups of men and women to evaluate the differences in skin oxygen properties, if any, between chronically sun exposed and less sun exposed skin. This study makes use of an oxygen sensing bandage device that can quantitatively measure both tissue oxygen partial pressure and oxygen consumption rate. Due to its early stage in development, the device has not yet been designed to control for high melanin content of skin. Thus only subjects with lower melanin content (i.e. Fitzpatrick skin types I - IV) will be included in the study. In addition, tattoo markings, scarring or significant natural discolorations can interfere with the imaging results by absorbing blue light and subjects with any of these will be excluded.
Key inclusion criteria (3 listed)
- Male or female
- Age groups: 20 - 30 and 55 - 65
- Fitzpatrick skin types I, II, III, and IV
Key exclusion criteria (13 listed)
- Fitzpatrick skin types V and above
- Tattoo markings anywhere on the arm(s)
- Significant scarring or discoloration (e.g. birthmarks) on the arm(s)
- Any current injuries, infections or wounds on the arm(s)
- Routinely (4+ doses per week) take high dosages of anti-inflammatory drugs (e.g. aspirin, ibuprofen, corticosteroids), immunosuppressive drugs, or antihistamine medications. However steroid nose drops and/or eye drops are permitted.
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 |
|---|---|---|
| Measurement of skin oxygenation and oxygen consumptionOxygenation properties will be measured using a transparent paint-on bandage formulation that consists of New-Skin liquid bandage, an oxygen-sensing metallo-porphyrin exhibiting bright red phosphorescence, and the green-fluorescing reference dye fluorescein. | Device | Older Men, Older Women, Younger Men, Younger Women |
Primary outcome
Differences in the relative (sun exposed vs nonexposed) and absolute oxygen properties within an individual and between the two age groups
Time frame: 20 min estimated per subject
The skin's partial pressure of oxygen and oxygen consumption rate is measured at 4 different locations on the subjects arms using the oxygen sensing device, where it is expected that that difference between more sun exposed regions and less sun exposed regions will be greater in the population of older adults.
1 secondary outcome
The differences in the relative (sun exposed vs nonexposed) and absolute oxygen properties between the sexes
Time frame: 20 min estimated per subject
Results and safety
The study was stopped early (reason given: Ran out of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Background: PubMed 28654595Koolen PGL, Li Z, Roussakis E, Paul MA, Ibrahim AMS, Matyal R, Huang T, Evans CL, Lin SJ. Oxygen-Sensing Paint-On Bandage: Calibration of a Novel Approach in Tissue Perfusion Assessment. Plast Reconstr Surg. 2017 Jul;140(1):89-96. doi: 10.1097/PRS.0000000000003421.
- Background: PubMed 26510549Roussakis E, Li Z, Nowell NH, Nichols AJ, Evans CL. Bright, "Clickable" Porphyrins for the Visualization of Oxygenation under Ambient Light. Angew Chem Int Ed Engl. 2015 Dec 1;54(49):14728-31. doi: 10.1002/anie.201506847. Epub 2015 Oct 29.
- Recruitment LinkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. This study was funded by a research gift from Procter \& Gamble. While the investigator is under no obligation to do so, research results and/or study data may be shared with the company for purposes of future scientific publications and/or research collaborations. However, information shared with the company will not include any identifiers that could be used to link data to individual subjects.
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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.
Conor L Evans, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Sun Exposure, run by Massachusetts General Hospital at 1 site in United States.
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 13 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: stopped early, as of the sponsor's last update on 14 Aug 2019. 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 United States. 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?
The study was stopped early (reason given: Ran out of funding). Results are not available in the source record.
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?
Differences in the relative (sun exposed vs nonexposed) and absolute oxygen properties within an individual and between the two age groups (time frame: 20 min estimated per subject). 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 NCT03311191, which also lists 2 linked publications.
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 14 Aug 2019; AzTrials last refreshed its copy on 30 Oct 2026.