Recruiting

Hand Sanitizer

Sponsor:

National Jewish Health

Code:

NCT04525521

Conditions

Dermatitis Hand

Skin Abnormalities

Atopic Dermatitis

Atopic Dermatitis Eczema

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Hand sanitizer and hand washing

Study Details

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.

Conditions

Dermatitis Hand

Skin Abnormalities

Atopic Dermatitis

Atopic Dermatitis Eczema

Study ID

NCT04525521

Start date

Dec 1, 2020

Status verified date

Mar, 2021

Completion date

Aug 20, 2021

Anticipated

Primary completion date

Aug 20, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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
  • 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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Hand sanitizer and hand washing

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

Primary outcome measure

  • Measure the change in transepidermal water loss and skin components after using hand sanitizer. [ Time Frame: Through study completion, up to 1 year ]
  • 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 ]

Central Contacts and Locations

Central contacts

Jessica Hui, MD

3033981728huij@njhealth.org

Locations

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Jessica Hui

303-398-1728huij@njhealth.org

More Information

Sponsor

National Jewish Health

Last update posted

Mar 2, 2021

Last verified

Mar, 2021

Keywords

  • Hand dermatitis
  • Skin barrier
  • Hand washing
  • Hand sanitizer
  • Eczema
  • Atopic dermatitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Jewish Health on 2021-03-02.