SMARTevans: Quantifying Skin Oxygenation Properties in Normal vs Sun Exposed Skin
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Younger Women Women ages 20-30 who are not pregnant will be painted with oxygen sensing bandage |
Device: Measurement 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.
|
| Younger Men Men ages 20-30 will be painted with oxygen sensing bandage |
Device: Measurement 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.
|
| Older Women Women ages 55-65 who are not pregnant will be painted with oxygen sensing bandage |
Device: Measurement 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.
|
| Older Men Men ages 55-65 will be painted with oxygen sensing bandage |
Device: Measurement 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.
|
Outcome Measures
Primary Outcome Measures
- Differences in the relative (sun exposed vs nonexposed) and absolute oxygen properties within an individual and between the two age groups [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.
Secondary Outcome Measures
- The differences in the relative (sun exposed vs nonexposed) and absolute oxygen properties between the sexes [20 min estimated per subject]
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)
Other Outcome Measures
- 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 response]
The 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
- Procter and Gamble
Investigators
- Principal Investigator: Conor L Evans, PhD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
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.
- Roussakis 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.
- 2017P000695