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Pre-SunBeam TEWL AUC

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: NCT04226092
Recruitment Status : Completed
First Posted : January 13, 2020
Last Update Posted : September 7, 2020
Sponsor:
Collaborators:
National Jewish Health
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Amy Paller, Northwestern University

Brief Summary:
Transepidermal Water Loss (TEWL) measurements are a valuable tool to determine the integrity of a person's skin barrier. In patients with skin conditions, like atopic dermatitis, skin barrier can be disrupted or weakened, leading to a more severe phenotype and disease characteristics. There are several commercially available TEWL measuring devices, including the Aquaflux AF200 and the GPSkin Barrier Pro. This study is a pilot study to determine if these two devices produce similar readings for TEWL/skin barrier on patients with and without atopic dematitis (AD). The research team would like to investigate whether these devices are comparable for initial TEWL readings as well as after several rounds of tape strips have been collected from the skin. Tape strips are small circular adhesives, much like tape, that remove the very outermost layers of skin cells. It will be important to know if both of these devices provide correlative values for TEWL once the outermost layers of the skin have been removed by tape stripping.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Device: GPSkin Barrier Pro Device: Aquaflux AF200 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pre-SunBeam Pilot Study: Comparative Assessment of TEWL Measurements From AquaFlux vs. Handheld GPSkin Pro in Young Children With and Without AD
Actual Study Start Date : November 7, 2019
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Subjects with atopic dermatitis Device: GPSkin Barrier Pro
This study is a pilot study to determine if this device produces similar readings than Aquaflux AF200 for TEWL/skin barrier on patients with and without atopic dematitis (AD).

Device: Aquaflux AF200
This study is a pilot study to determine if this device produces similar readings than GPSkin Barrier Pro for TEWL/skin barrier on patients with and without atopic dematitis (AD).

Experimental: Control subjects Device: GPSkin Barrier Pro
This study is a pilot study to determine if this device produces similar readings than Aquaflux AF200 for TEWL/skin barrier on patients with and without atopic dematitis (AD).

Device: Aquaflux AF200
This study is a pilot study to determine if this device produces similar readings than GPSkin Barrier Pro for TEWL/skin barrier on patients with and without atopic dematitis (AD).




Primary Outcome Measures :
  1. Correlation coefficient of TEWL curves [ Time Frame: baseline ]
    Correlation in TEWL curve (AUC) between two TEWL devices (Aquaflux AF200 and GPSkin Barrier Pro) in non-lesional atopic dermatitis and healthy skin.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Parent guardian must be able to understand and provide informed consent and participant provide assent as applicable per Institutional Review Board (IRB) guidelines and regulations.
  2. Male or female, less than or equal to 3 years of age inclusive at Screening
  3. Active AD using Standard Diagnostic Criteria (AAD criteria, Eichenfield et al, 2014). Participant must have an area of non-lesional AD (EASI of 0) within 5 cm. of the measured lesional area within the same region. Participant must have lesional and nonlesional areas of at least 3 cm in diameter to allow for both devices to be tested in contiguous areas OR FOR HEALTHY CONTROLS
  4. Participant must meet all of the following criteria:

    1. No personal history or current manifestations of AD; no current food allergy, asthma, allergic rhinitis (based on self-report)
    2. No evidence of dry skin or other skin issue (EASI score of 0)

Exclusion Criteria:

  1. Inability or unwillingness of a parent guardian to give written informed consent, or participant to give assent, if applicable, or to comply with study protocol
  2. Who have any skin disease other than AD that might compromise the stratum corneum barrier in infants and young children (e.g., ichthyosis, psoriasis, extensive seborrheic dermatitis, scabies)
  3. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
  4. Use of any topical product (e.g., emollient, topical corticosteroids, topical immunomodulatory agents, topical antibiotics) on extremity for testing within 2 hours of the Enrollment Visit.

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): NCT04226092


Locations
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United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Illinois
Northwestern University/Lurie Children's Hosptial
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Jewish Health
National Institute of Allergy and Infectious Diseases (NIAID)
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Responsible Party: Amy Paller, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT04226092    
Other Study ID Numbers: AP09162019
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amy Paller, Northwestern University:
Transepidermal Water Loss
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases