Skin Barrier Dysfunction and the Role of Skin Barrier Restoration

April 30, 2021 updated by: Gary Fisher, University of Michigan

Skin Barrier Dysfunction and the Role of Skin Barrier Restoration on Cutaneous and Systemic Inflammation in the Aged Population

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Early Phase 1

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
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 30 days

Collaborators and Investigators

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

Sponsor

University of Michigan

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

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)

May 16, 2018

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

October 29, 2018

First Submitted That Met QC Criteria

October 30, 2018

First Posted (Actual)

November 2, 2018

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00138533 / Derm 719

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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