Quantifying Skin Oxygenation Properties in Normal vs Sun Exposed Skin

Terminated

• Conditions: Healthy; Sun Exposure
• Interventions: Device: Measurement of skin oxygenation and oxygen consumption

• Registration Number: NCT03311191
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2017-07-17
• Study First Submitted: 2017-10-05
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-17
• Primary Completion: 2019-06-06
• Study Completion: 2019-06-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Younger Women	Measurement of skin oxygenation and oxygen consumption	Women ages 20-30 who are not pregnant will be painted with oxygen sensing bandage
Younger Men	Measurement of skin oxygenation and oxygen consumption	Men ages 20-30 will be painted with oxygen sensing bandage
Older Women	Measurement of skin oxygenation and oxygen consumption	Women ages 55-65 who are not pregnant will be painted with oxygen sensing bandage
Older Men	Measurement of skin oxygenation and oxygen consumption	Men ages 55-65 will be painted with oxygen sensing bandage

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States