Skin Barrier Dysfunction and the Role of Skin Barrier Restoration

NCT03728569 | Terminated Early Phase 1

• 1 other identifier: HUM00138533 / Derm 719
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in skin hydration status in aged and young subjects

  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

Study Arms (2)

Subjects over the age of 70 yrs receiving Vanicream

OTHER

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; Other: Vanicream Cleansing Soap

Subjects between 18 and 30 yrs receiving Vanicream

OTHER

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; Other: Vanicream Cleansing Soap

Interventions

Vanicream Moisturizing Skin Cream OTHER

Vanicream Moisturizing Skin Cream daily application

Subjects between 18 and 30 yrs receiving Vanicream; Subjects over the age of 70 yrs receiving Vanicream

Vanicream Cleansing Soap OTHER

Vanicream Cleansing Soap daily use

Subjects between 18 and 30 yrs receiving Vanicream; Subjects over the age of 70 yrs receiving Vanicream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (21)

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• Constantin MM, Poenaru E, Poenaru C, Constantin T. Skin Hydration Assessment through Modern Non-Invasive Bioengineering Technologies. Maedica (Bucur). 2014 Mar;9(1):33-8.

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• 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

  BACKGROUND

• Pinnagoda J, Tupker RA, Agner T, Serup J. Guidelines for transepidermal water loss (TEWL) measurement. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1990 Mar;22(3):164-78. doi: 10.1111/j.1600-0536.1990.tb01553.x.

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MeSH Terms

Conditions

Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gary Fisher, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Both groups, young and old, will receive the same intervention; therefore, single group study model was chosen.

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 2, 2018
• Study Start: May 16, 2018
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)