Clinical trial NCT03311191: Quantifying Skin Oxygenation Properties in Normal vs Sun Exposed Skin
Official title: Quantifying Skin Oxygenation Properties in Normal vs Sun Exposed Skin
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy
Sun Exposure
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2017-10-17
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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

Primary outcomes:
measure: Differences in the relative (sun exposed vs nonexposed) and absolute oxygen properties within an individual and between the two age groups
timeFrame: 20 min estimated per subject
Secondary outcomes:
measure: The differences in the relative (sun exposed vs nonexposed) and absolute oxygen properties between the sexes
timeFrame: 20 min estimated per subject
Other outcomes:
measure: The oxygen properties connected to lifestyle choices, such as sun-seeking behavior, lifetime sun exposure levels, and smoking.
timeFrame: 20 min estimated per subject, plus time to fill in questionnaire response
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Conor L Evans, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.