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Clinical Trials/NCT04525521
NCT04525521
Unknown
N/A

Hand Sanitizer Effects on the Skin Barrier

National Jewish Health1 site in 1 country40 target enrollmentDecember 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dermatitis Hand
Sponsor
National Jewish Health
Enrollment
40
Locations
1
Primary Endpoint
Measure the change in transepidermal water loss and skin components after using hand sanitizer.
Last Updated
5 years ago

Overview

Brief Summary

Hand washing and the use of hand sanitizers are important interventions in disease prevention. Engaging in frequent hand washing is especially effective in preventing the spread of viruses, as this removes microbes and prevents the spread to others. Hand dermatitis, however, is a common occurrence in certain occupations, such as healthcare workers. With the onset of the SARS-CoV2 (COVID-19) pandemic, hand hygiene measures are further enforced as there is no cure or vaccine for this virus.

In the study, the effects of hand washing and the use of hand sanitizer on skin proteins and lipids will be assessed.

Detailed Description

Hand washing and the use of hand sanitizers are important interventions in disease prevention. Engaging in frequent hand washing is especially effective in preventing the spread of viruses, as this removes microbes and prevents the spread to others. Hand dermatitis, however, is a common occurrence in certain occupations, such as healthcare workers. With the onset of the SARS-CoV2 (COVID-19) pandemic, hand hygiene measures are further enforced as there is no cure or vaccine for this virus. The stratum corneum is in the outer layer of the epidermis, and it contains several proteins and lipids that are important for skin health. This skin layer can be disrupted by agents that cause skin dryness and irritation, resulting in a dysfunctional skin barrier when there is loss of filaggrin breakdown products, also referred to as natural moisturizing factor (NMF), and lipids. This then leads to the unwanted dermatologic effects of skin dermatitis, and in some patients, contact dermatitis. While it is known that frequent hand washing and hand sanitizer use causes hand dermatitis, the effects on skin barrier proteins and lipids has not been studied. In this study, the effects of hand washing and the use of hand sanitizer on epidermal proteins and lipids will be assessed. The skin barrier will be examined with skin tape strips (STS) and transepidermal water loss (TEWL) before and after topical skin exposure to hand sanitizer use and hand washing. Questionnaires will be administered to inquire about allergy history, frequency of hand washing, and use of detergents and soaps.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
August 20, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria of the AD group:
  • Individuals with atopic dermatitis, ages 18-60 years old.
  • Inclusion criteria of the non-atopic group, ages 18-60 years old:
  • Individuals with no history of atopic dermatitis, contact dermatitis, food allergy, asthma, or allergic rhinitis.

Exclusion Criteria

  • Exclusion criteria of all subjects:
  • Subject has taken systemic immunosuppressive drugs including oral steroids within 30 days of skin barrier assessment
  • Subject has received immunotherapy in the past year
  • Subject has received any biologic medications within 5 half-lives or 16 weeks, whichever is longer
  • Subject has received any investigational drugs within 5 half-lives or 8 weeks, whichever is longer
  • Subject has taken anti-anxiety, antidepressant, or anticoagulant medications in the last 30 days
  • Subject has received total body phototherapy (e.g., ultraviolet light B \[UVB\], psoralen plus ultraviolet light A \[PUVA\], tanning beds \[\>1 visit per week\]) within 30 days of skin barrier assessment
  • Subject has used topical corticosteroids, topical immunomodulatory agents, or topical antibiotics on the extremity being evaluated within 7 days of skin barrier assessment
  • Subject has a severe concurrent disease or immunosuppression
  • Subject has a history of a severe reaction to latex, tape, or adhesives

Outcomes

Primary Outcomes

Measure the change in transepidermal water loss and skin components after using hand sanitizer.

Time Frame: Through study completion, up to 1 year

Skin barrier assessments at baseline, then after hand sanitizer use will be performed. Analysis of skin filaggrin breakdown products, lipid profiles, and transepidermal water loss will be compared.

Measure the change in transepidermal water loss and skin components after hand washing with soap and water.

Time Frame: Through study completion, up to 1 year

Skin barrier assessments after hand washing with soap and water will be performed. Analysis of skin filaggrin breakdown products, lipid profiles, and transepidermal water loss will be compared.

Secondary Outcomes

  • Individual reporting of hand dryness and environmental exposures(Through study completion, up to 1 year)

Study Sites (1)

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