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Quantifying Skin Oxygenation Properties in Normal vs Sun Exposed Skin

Quantifying Skin Oxygenation Properties in Normal vs Sun Exposed Skin

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03311191
Acronym
SMARTevans
Enrollment
11
Registered
2017-10-17
Start date
2017-07-17
Completion date
2019-06-06
Last updated
2019-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Sun Exposure

Brief 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.

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.

Interventions

DEVICEMeasurement of skin oxygenation and oxygen consumption

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.

Sponsors

Procter and Gamble
CollaboratorINDUSTRY
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Male or female * Age groups: 20 - 30 and 55 - 65 * Fitzpatrick skin types I, II, III, and IV

Exclusion criteria

* 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. * 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

Design outcomes

Primary

MeasureTime frameDescription
Differences in the relative (sun exposed vs nonexposed) and absolute oxygen properties within an individual and between the two age groups20 min estimated per subjectThe 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.

Secondary

MeasureTime frameDescription
The differences in the relative (sun exposed vs nonexposed) and absolute oxygen properties between the sexes20 min estimated per subjectThe 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)

Other

MeasureTime frameDescription
The oxygen properties connected to lifestyle choices, such as sun-seeking behavior, lifetime sun exposure levels, and smoking.20 min estimated per subject, plus time to fill in questionnaire responseThe skin's partial pressure of oxygen and oxygen consumption rate is measured with the oxygen sensing device and compared between groups stratified by lifestyle, as based on subject responses from the questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026