Quantifying Skin Oxygenation Properties in Normal vs Sun Exposed Skin

NCT ID: NCT03311191

Last Updated: 2019-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-17

Study Completion Date

2019-06-06

Brief Summary

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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

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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.

Conditions

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Healthy Sun Exposure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Younger Women

Women ages 20-30 who are not pregnant will be painted with oxygen sensing bandage

Measurement of skin oxygenation and oxygen consumption

Intervention Type 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.

Younger Men

Men ages 20-30 will be painted with oxygen sensing bandage

Measurement of skin oxygenation and oxygen consumption

Intervention Type 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.

Older Women

Women ages 55-65 who are not pregnant will be painted with oxygen sensing bandage

Measurement of skin oxygenation and oxygen consumption

Intervention Type 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.

Older Men

Men ages 55-65 will be painted with oxygen sensing bandage

Measurement of skin oxygenation and oxygen consumption

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Conor L Evans

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Conor L Evans, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28654595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26510549 (View on PubMed)

Related Links

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Other Identifiers

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2017P000695

Identifier Type: -

Identifier Source: org_study_id

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