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Skin Barrier Dysfunction and the Role of Skin Barrier Restoration

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ClinicalTrials.gov Identifier: NCT03728569
Recruitment Status : Suspended (Enrollment and interactions/interventions paused due to COVID-19. Expected to resume in the future. This is not a suspension of IRB approval)
First Posted : November 2, 2018
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Gary Fisher, University of Michigan

Brief Summary:
The objective of this exploratory study is to gain an understanding of cutaneous and systemic inflammation and how restoration of the skin barrier through the use of moisturizer may restore the skin barrier function and reduce systemic inflammation in elderly humans compared to the young. The exploratory study will consist of three visits per subject. Subjects will be instructed to apply a moisturizer (Vanicream Moisturizing Skin Cream) over the entire skin surface from the neck down twice daily for up to 30 days.

Condition or disease Intervention/treatment Phase
Cutaneous Inflammation Other: Vanicream Moisturizing Skin Cream Other: Vanicream Cleansing Soap Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Both groups, young and old, will receive the same intervention; therefore, single group study model was chosen.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Skin Barrier Dysfunction and the Role of Skin Barrier Restoration on Cutaneous and Systemic Inflammation in the Aged Population
Actual Study Start Date : May 16, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Subjects over the age of 70 yrs receiving Vanicream
Subjects will be instructed to apply a moisturizer over the entire skin surface from the neck down twice daily. Subjects will also be required to use a bar soap (Vanicream Cleansing Bar) once daily and avoid application of other soaps or cleaners to the body for the duration of the study.
Other: Vanicream Moisturizing Skin Cream
Vanicream Moisturizing Skin Cream daily application

Other: Vanicream Cleansing Soap
Vanicream Cleansing Soap daily use

Subjects between 18 and 30 yrs receiving Vanicream
Subjects will be instructed to apply a moisturizer over the entire skin surface from the neck down twice daily. Subjects will also be required to use a bar soap (Vanicream Cleansing Bar) once daily and avoid application of other soaps or cleaners to the body for the duration of the study.
Other: Vanicream Moisturizing Skin Cream
Vanicream Moisturizing Skin Cream daily application

Other: Vanicream Cleansing Soap
Vanicream Cleansing Soap daily use




Primary Outcome Measures :
  1. Change in skin hydration status in aged and young subjects [ Time Frame: up to 30 days ]
    Trans-epidermal water loss (TEWL) will be performed on the upper arm and buttocks at Visits 1 and 2. This instrument will measure the amount of water that is lost through the skin. The change in skin hydration status in each subject will be assessed and compared between groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Aged group (>70 years old)

  • In good general health
  • Body mass index (BMI) preferably in the healthy range (approximately 25 kg/m2) and no greater than 30 kg/m2
  • Fitzpatrick skin types I-V
  • Disrupted skin barrier defined as transepidermal water loss (TEWL) >5 g/m2/h on the upper arms or >3 g/m2/h on the buttocks
  • Clinical signs of skin dryness as determined by the investigator.
  • No disease states or physical conditions that would impair evaluation of the biopsy sites
  • Signed, written and witnessed informed consent form
  • Willing to comply with study procedures

Young group (18-30 years old)

  • Good general health
  • BMI preferably in the healthy range (approximately 25 kg/m2) and no greater than 30 kg/m2
  • Fitzpatrick skin types I-V
  • Disrupted skin barrier defined as transepidermal water loss (TEWL) >5 g/m2/h on the upper arms or >3 g/m2/h on the buttocks
  • Clinical signs of skin dryness as determined by the investigator
  • No disease states or physical conditions that would impair evaluation of the biopsy sites
  • Signed, written and witnessed informed consent form
  • Willing to comply with study procedures

Exclusion Criteria:

  • Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol (determined by self-report; if subjects are unsure of their pregnancy status, they will be excluded).
  • Frailty as determined by research study nurse
  • History of inflammatory skin conditions such as psoriasis or atopic dermatitis.
  • History of uncontrolled inflammatory or autoimmune disease.
  • History of keloids or any other condition that would complicate wound healing
  • History of allergic reactions to local lidocaine
  • Frequent nonsteroidal anti-inflammatory drug (NSAID) use (not including low dose aspirin) and unwilling/unable to discontinue NSAIDS for 2 weeks prior to enrollment to the end of the study.
  • Systemic steroids (excluding inhaled steroids for asthma) and unwilling/unable to discontinue systemic steroids for 3 weeks prior to enrollment to the end of the study.
  • Topical corticosteroid use within 2 weeks of enrollment.
  • Topical immunomodulation use such as calcineurin inhibitors within 2 weeks of enrollment
  • Other anti-inflammatory or immunodulatory medications (immunosuppression)
  • Received an experimental drug or used an experimental device 30 days prior to admission to the study.

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): NCT03728569


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Gary Fisher, PhD University of Michigan
Publications:
Mundelein M, Valentin B, Chabicovsky R, et al. Transepidermal water loss (TEWL) measurements with two novel sensors based on different sensing principles. Sensors and Actuators A Physical 2007;142(1): DOI 10.1016/j.sna.2007.04.012

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Responsible Party: Gary Fisher, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03728569    
Other Study ID Numbers: HUM00138533 / Derm 719
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 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
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes