Not provided
Not provided
Not provided
Not provided
Not provided
Ran out of funding
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Younger Women | Women ages 20-30 who are not pregnant will be painted with oxygen sensing bandage |
| |
| Younger Men | Men ages 20-30 will be painted with oxygen sensing bandage |
| |
| Older Women | Women ages 55-65 who are not pregnant will be painted with oxygen sensing bandage |
| |
| Older Men | Men ages 55-65 will be painted with oxygen sensing bandage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of skin oxygenation and oxygen consumption | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 min estimated per subject |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 20 min estimated per subject |
| Measure | Description | Time Frame |
|---|---|---|
| The oxygen properties connected to lifestyle choices, such as sun-seeking behavior, lifetime sun exposure levels, and smoking. | 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 | 20 min estimated per subject, plus time to fill in questionnaire response |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Conor L Evans, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28654595 | Background | 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. | |
| 26510549 | Background | 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. |
| Label | URL |
|---|---|
| Recruitment Link | View source |
Not provided
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.
As collected; until the study is complete and the results and published.
Image data files and subject questionnaires may be used after the study for future research. However, no individually identifiable patient information will be correlated with or otherwise used with the study data. Specimens and data will not be stored at collaborating sites outside of Partners Healthcare.
Not provided
Not provided
Not provided
Not provided
Not provided
|