Quantifying Skin Oxygenation Properties in Normal vs Sun Exposed Skin

Healthy Clinical Trial

— SMARTevans  

Official title:

Quantifying Skin Oxygenation Properties in Normal vs Sun Exposed Skin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03311191
• Other study ID #: 2017P000695
• Status: Terminated
• Start date: July 17, 2017
• Est. completion date: June 6, 2019

Study information

• Verified date: August 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 6, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Sun Exposure

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Procter and Gamble

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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

External Links

•   Recruitment Link