NCT03311191

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

October 5, 2017

Last Update Submit

August 12, 2019

Conditions

HealthySun Exposure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The differences in the relative (sun exposed vs nonexposed) and absolute oxygen properties between the sexes

    20 min estimated per subject

Other Outcomes (1)

  • The oxygen properties connected to lifestyle choices, such as sun-seeking behavior, lifetime sun exposure levels, and smoking.

    20 min estimated per subject, plus time to fill in questionnaire response

Study Arms (4)

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

Younger Men

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

Device: Measurement of skin oxygenation and oxygen consumption

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

Older Men

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

Device: Measurement of skin oxygenation and oxygen consumption

Interventions

Measurement of skin oxygenation and oxygen consumptionDEVICE

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 MenOlder WomenYounger MenYounger Women

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Male or female
  • Age groups: 20 - 30 and 55 - 65
  • Fitzpatrick skin types I, II, III, and IV

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related 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.

    PMID: 28654595BACKGROUND

  • 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.

    PMID: 26510549BACKGROUND

Related Links

Study Officials

  • Conor L Evans, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 5, 2017

First Posted

October 17, 2017

Study Start

July 17, 2017

Primary Completion

June 6, 2019

Study Completion

June 6, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
As collected; until the study is complete and the results and published.
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.

Locations

US(1)