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

August 12, 2019 updated by: Conor L Evans, Massachusetts General Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 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.
20 min estimated per subject

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The differences in the relative (sun exposed vs nonexposed) and absolute oxygen properties between the sexes
Time Frame: 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)
20 min estimated per subject

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The oxygen properties connected to lifestyle choices, such as sun-seeking behavior, lifetime sun exposure levels, and smoking.
Time Frame: 20 min estimated per subject, plus time to fill in questionnaire response
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Procter and Gamble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Conor L Evans, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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