Quantifying Skin Oxygenation Properties in Normal vs Sun Exposed Skin (SMARTevans)

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.

Study Overview

• Status: Terminated
• Conditions: Healthy; Sun Exposure
• Intervention / Treatment: Device: Measurement of skin oxygenation and oxygen consumption

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 Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Procter and Gamble
• Investigators: Principal Investigator: Conor L Evans, PhD, Massachusetts General Hospital

Publications and helpful links

General 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.

Helpful Links

• Recruitment Link

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Actual): June 6, 2019
• Study Completion (Actual): June 6, 2019

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2017P000695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: As collected; until the study is complete and the results and published.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No