Skin Barrier Dysfunction and the Role of Skin Barrier Restoration

Early Phase 1

Terminated

• Conditions: Cutaneous Inflammation
• Interventions: Other: Vanicream Moisturizing Skin Cream; Other: Vanicream Cleansing Soap

• Registration Number: NCT03728569
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-16
• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-11-02
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects between 18 and 30 yrs receiving Vanicream	Vanicream Cleansing Soap	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.
Subjects over the age of 70 yrs receiving Vanicream	Vanicream Moisturizing Skin Cream	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.
Subjects over the age of 70 yrs receiving Vanicream	Vanicream Cleansing Soap	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.
Subjects between 18 and 30 yrs receiving Vanicream	Vanicream Moisturizing Skin Cream	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.

Primary Outcome Measures

Name	Time	Method
Change in skin hydration status in aged and young subjects	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States