Hand Sanitizer Effects on the Skin Barrier

NCT ID: NCT04525521

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-08-20

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.

Conditions

Dermatitis Hand; Skin Abnormalities; Atopic Dermatitis; Atopic Dermatitis Eczema

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-Atopic Individuals

Individuals with no history of atopic dermatitis, food allergy, asthma, or allergic rhinitis will be recruited to this cohort. Skin studies (transepidermal water loss and skin tape strips) will be performed on the non-dominant hand at baseline, after hand sanitizer use, and after hand washing with soap and water.

Hand sanitizer and hand washing

Intervention Type: OTHER

All subjects will cleanse their hands with hand sanitizer, followed by hand washing with soap and water

Individuals with Atopic Dermatitis

Individuals with history of atopic dermatitis will be recruited to this cohort. Skin studies (transepidermal water loss and skin tape strips) will be performed on the non-dominant hand at baseline, after hand sanitizer use, and after hand washing with soap and water.

Hand sanitizer and hand washing

Intervention Type: OTHER

All subjects will cleanse their hands with hand sanitizer, followed by hand washing with soap and water

Interventions

Hand sanitizer and hand washing

All subjects will cleanse their hands with hand sanitizer, followed by hand washing with soap and water

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Individuals with atopic dermatitis, ages 18-60 years old.

• Individuals with no history of atopic dermatitis, contact dermatitis, food allergy, asthma, or allergic rhinitis.

Exclusion Criteria

• 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
• Subject is pregnant or lactating

For the medications below, they have to be temporarily withheld before participation in the study:

• If the subject is taking oral antihistamines, they will need to be withheld for five days prior to the skin barrier study.
• If the subject is taking oral antibiotics, antivirals, antifungals, or antiparasitics, the skin barrier studies can be scheduled seven days after the last dose has been taken.
• If the subject is taking topical medications including (but not restricted to) Elidel, Protopic, topical corticosteroids and topical antibiotics, they will need to be withheld on the hand being evaluated seven days prior to the skin barrier studies. Moisturizers will also need to be withheld on the area 24 hours prior to the visit. The subject cannot have taken a bleach bath within 7 days of the visit, and the subject cannot take a bath or shower on the day of the visit.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Hui, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

National Jewish Health

Denver, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica Hui, MD

Role: CONTACT

huij@njhealth.org

3033981728

Facility Contacts

Jessica Hui

Role: primary

huij@njhealth.org

303-398-1728

Other Identifiers

3030005053

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HS 0720

Identifier Type: -

Identifier Source: org_study_id