Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 24 for:    Porphyrins

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03311191
Recruitment Status : Terminated (Ran out of funding)
First Posted : October 17, 2017
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
Conor L Evans, 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.

Condition or disease Intervention/treatment
Healthy Sun Exposure Device: Measurement of skin oxygenation and oxygen consumption

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Quantifying Skin Oxygenation Properties in Normal vs Sun Exposed Skin
Actual Study Start Date : July 17, 2017
Actual Primary Completion Date : June 6, 2019
Actual Study Completion Date : June 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03311191


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Procter and Gamble
Investigators
Layout table for investigator information
Principal Investigator: Conor L Evans, PhD Massachusetts General Hospital

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Conor L Evans, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03311191     History of Changes
Other Study ID Numbers: 2017P000695
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No