Hand EczemaNCT04375410
Consequences of Intensified Handwash and Hand Disinfection Among Children During the COVID19 Pandemic
An observational study of Hand Eczema and Hand Dermatitis, run by Regionshospital Nordjylland at 1 site in Denmark.
Trial summary
During the COVID-19 pandemic after reopening of the country, school, kindergarten and daycare, children have been obligated to do frequent handwash. The study group wished to investigate whether this has had implications on symptoms of dry, red, itchy or sore hands and hand eczema. Read more about this study
- Who is it for?
- Ages 0 to 13 years
- Conditions the study is for
- Hand Eczema, Hand Dermatitis, Covid19
- How many people
- 6,273 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Apr 2020to 10 May 2020
- 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 0 to 13 years
- All sexes
- Child
Study population: Children i Hjoerring, Aalborg, Rebild or Skanderborg municipaility
Who may be able to join
- All children returned to daycare, kindergarten or school after covid19 close down of the country
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Re-opening of the Country and Dermal Consequences of Mandatory Intensified Handwash and Hand Disinfection Among a Danish Pediatric Population During the COVID19 Pandemic
During the COVID-19 pandemic after reopening of the country, school, kindergarten and daycare, children have been obligated to do frequent handwash. The study group wished to investigate whether this has had implications on symptoms of dry, red, itchy or sore hands and hand eczema. The investigation was performed within the first and second week after reopening by questionnaires distributed to parents electronically via schools, kindergartens and daycare facilities electronic platforms.
Read the detailed description
During the COVID-19 pandemic Denmark closed down, including schools, kindergartens and daycare. After reopening of the country 5 weeks later obligatory frequent handwash was a requirement from the government and routines has been implemented at all reopened schools, kindergartens and daycare. The study group wished to investigate whether this has had implications on symptoms of dry, red, itchy or sore hands and hand eczema. Also the study group wished to investigate if frequency or use of hand disinfection mattered. The investigation was performed within the first and second week after reopening by questionnaires distributed to parents electronically via schools, kindergartens and daycare electronic platforms. The questionnaire included 20 questions on demographics, frequency of hand wash and use of disinfectants, current and previous symptoms of eczema, atopic dermatitis and dispositions.
- Conditions
- Hand Eczema, Hand Dermatitis, Covid19
- Keywords
- Dermatitis, Hand wash, Hand disinfection, Children, Pediatric
- Medical subject headings
- COVID-19, Dermatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermal reaction to frequent hand wash and disinfection in children
Dermal symptoms as a result of frequent hand wash and disinfection among children
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start22 Apr 2020
- Primary completion30 Apr 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand EczemaStudies 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
- Cross-sectional
- Enrolment
- 6,273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospital Nordjylland
- Sponsor type
- Other government
- Collaborators
- Aalborg University Hospital
- Responsible party
- Principal investigator, Tine Caroc Warner, Regionshospital Nordjylland
- Investigators
- Soeren Haghstroem, M.D, PhD, Principal investigator, Aalborg University Hospital, Aalborg UniversityLuise Borch, M.D, PhD, Principal investigator, Regional Hospital West Jutland, Herning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375410
- Sponsor's protocol ID
- SH042020
- Status last verified
- Mar 2021
- First submitted
- 30 Apr 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Borch L, Thorsteinsson K, Warner TC, Mikkelsen CS, Bjerring P, Lundbye-Christensen S, Arvesen K, Hagstroem S. COVID-19 reopening causes high risk of irritant contact dermatitis in children. Dan Med J. 2020 Aug 6;67(9):A05200357.
PubMed 32800064
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-opening of the Country and Dermal Consequences of Mandatory Intensified Handwash and Hand Disinfection Among a Danish Pediatric Population During the COVID19 Pandemic
- ClinicalTrials.gov ID
- NCT04375410
- Acronym / sponsor ID
- SH042020
- Conditions
- Hand Eczema, Hand Dermatitis, Covid19
- Keywords
- Dermatitis, Hand wash, Hand disinfection, Children, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,273 participants (actual)
- Lead sponsor
- Regionshospital NordjyllandOther government
- Collaborators
- Aalborg University Hospital
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 5 May 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.
During the COVID-19 pandemic after reopening of the country, school, kindergarten and daycare, children have been obligated to do frequent handwash. The study group wished to investigate whether this has had implications on symptoms of dry, red, itchy or sore hands and hand eczema. The investigation was performed within the first and second week after reopening by questionnaires distributed to parents electronically via schools, kindergartens and daycare facilities electronic platforms.
Detailed description
During the COVID-19 pandemic Denmark closed down, including schools, kindergartens and daycare. After reopening of the country 5 weeks later obligatory frequent handwash was a requirement from the government and routines has been implemented at all reopened schools, kindergartens and daycare. The study group wished to investigate whether this has had implications on symptoms of dry, red, itchy or sore hands and hand eczema. Also the study group wished to investigate if frequency or use of hand disinfection mattered. The investigation was performed within the first and second week after reopening by questionnaires distributed to parents electronically via schools, kindergartens and daycare electronic platforms. The questionnaire included 20 questions on demographics, frequency of hand wash and use of disinfectants, current and previous symptoms of eczema, atopic dermatitis and dispositions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 0 to 13 years
- Sex
- All
- Age groups
- Child
- Study population
- Children i Hjoerring, Aalborg, Rebild or Skanderborg municipaility
Key inclusion criteria (1 listed)
- All children returned to daycare, kindergarten or school after covid19 close down of the country
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dermal reaction to frequent hand wash and disinfection in children
Time frame: 9 days
Dermal symptoms as a result of frequent hand wash and disinfection among children
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Derived from this study: PubMed 32800064Borch L, Thorsteinsson K, Warner TC, Mikkelsen CS, Bjerring P, Lundbye-Christensen S, Arvesen K, Hagstroem S. COVID-19 reopening causes high risk of irritant contact dermatitis in children. Dan Med J. 2020 Aug 6;67(9):A05200357.
- Individual participant dataSharing planned: Undecided
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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.
Soeren Haghstroem, M.D, PhD principal investigator
Aalborg University Hospital, Aalborg University
Luise Borch, M.D, PhD principal investigator
Regional Hospital West Jutland, Herning
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 Hand Eczema and Hand Dermatitis, run by Regionshospital Nordjylland at 1 site in Denmark.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Apr 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermal reaction to frequent hand wash and disinfection in children (time frame: 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04375410, which also lists 1 linked publication.
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 1 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.