ClinicalTrials.gg
Status unknownNCT04525521Updated Mar 2, 2021

Hand Sanitizer Effects on the Skin Barrier

An observational study in Dermatitis Hand, Skin Abnormalities and Atopic Dermatitis, sponsored by National Jewish Health. Status unknown at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-03-02.

Sponsored by National Jewish Health · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dermatitis Hand
  • Skin Abnormalities
  • Atopic Dermatitis
  • Atopic Dermatitis Eczema

Keywords

  • Hand dermatitis
  • Skin barrier
  • Hand washing
  • Hand sanitizer
  • Eczema
  • Atopic dermatitis
03

In context

Skin Abnormalities

39 studies on the registry are indexed under Skin Abnormalities; 7 are open to participants now.

This study's planned enrollment of 40 is below the median of 140 across 11 observational studies indexed under Skin Abnormalities.

Browse Skin Abnormalities studies →

Lead sponsor

National Jewish Health is the lead sponsor of 109 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Subjects will have either atopic dermatitis or no history of atopic conditions.

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 drugs including oral 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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

    Other: Hand sanitizer and hand washing

  • 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.

    Other: Hand sanitizer and hand washing

Interventions

  • OtherHand sanitizer and hand washing

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

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: Through study completion, up to 1 year

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

    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.

    Time frame: Through study completion, up to 1 year

Secondary outcomes

  1. Individual reporting of hand dryness and environmental exposures

    Questionnaires will capture symptoms of hand dryness, frequency of hand washing, and other environmental exposures. This data will be compared to the degree of transepidermal water loss and skin barrier findings.

    Time frame: Through study completion, up to 1 year

07

Study locations

1 of 1 sites recruiting
  • National Jewish Health
    Denver, Colorado 80206, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2020 (actual). Primary completion is estimated for Aug 2021, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2020
First posted
Aug 25, 2020
StartActual
Dec 1, 2020
Primary completionEst.
Aug 20, 2021
CompletionEst.
Aug 20, 2021
Last update
Mar 2, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04525521
Responsible party
Sponsor
First posted
Aug 25, 2020
Start date
Dec 1, 2020
Primary completion
Aug 20, 2021 (estimated)
Completion
Aug 20, 2021 (estimated)
Last update
Mar 2, 2021

Study contacts

Jessica Hui, MD
Contact
huij@njhealth.org
3033981728
Jessica Hui, MD
principal investigator · National Jewish Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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