Dermatitis HandNCT04525521
Hand Sanitizer Effects on the Skin Barrier
An observational study of Dermatitis Hand and Skin Abnormalities, run by National Jewish Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dermatitis Hand, Skin Abnormalities, Atopic Dermatitis
- What is being tested?
- Hand sanitizer and hand washing
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 20 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: Subjects will have either atopic dermatitis or no history of atopic conditions.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Jessica Hui, 303-398-1728, huij@njhealth.org
About this study
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.
- Being tested
- Hand sanitizer and hand washing
- Keywords
- Hand dermatitis, Skin barrier, Hand washing, Hand sanitizer, Eczema, Atopic dermatitis
- Medical subject headings
- Skin Abnormalities, Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand sanitizer and hand washingOther
All subjects will cleanse their hands with hand sanitizer, followed by hand washing with soap and water
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Hand sanitizer and hand washing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, up to 1 year
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.
Measured: 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.
Measured: Through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start1 Dec 2020
- Primary completion20 Aug 2021 (estimated)
- Study completion20 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Hui, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525521
- Sponsor's protocol ID
- HS 0720
- Other IDs
- 3030005053
- Status last verified
- Mar 2021
- First submitted
- 18 Aug 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Sanitizer Effects on the Skin Barrier
- ClinicalTrials.gov ID
- NCT04525521
- Acronym / sponsor ID
- HS 0720
- Keywords
- Hand dermatitis, Skin barrier, Hand washing, Hand sanitizer, Eczema, Atopic dermatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 20 Aug 2021 (estimated)
- Study completion
- 20 Aug 2021 (estimated)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Atopic Individuals | – | Other: Hand sanitizer and hand washingIndividuals 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 | – | Other: Hand sanitizer and hand washingIndividuals 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Subjects will have either atopic dermatitis or no history of atopic conditions.
Key inclusion criteria (3 listed)
- Individuals with atopic dermatitis, ages 18-60 years old.
- Individuals with no history of atopic dermatitis, contact dermatitis, food allergy, asthma, or allergic rhinitis.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand sanitizer and hand washingAll subjects will cleanse their hands with hand sanitizer, followed by hand washing with soap and water | Other | Individuals with Atopic Dermatitis, Non-Atopic Individuals |
Primary outcome
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.
1 secondary outcome
Individual reporting of hand dryness and environmental exposures
Time frame: Through study completion, up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Hui, MD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis Hand and Skin Abnormalities, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Hui, MD (3033981728, huij@njhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.