NCT04525521

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
Last Updated

March 2, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

August 18, 2020

Last Update Submit

March 1, 2021

Conditions

Dermatitis HandSkin AbnormalitiesAtopic DermatitisAtopic Dermatitis Eczema

Keywords

Hand dermatitisSkin barrierHand washingHand sanitizerEczemaAtopic dermatitis

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Through study completion, up to 1 year

Secondary Outcomes (1)

  • Individual reporting of hand dryness and environmental exposures

    Through study completion, up to 1 year

Study Arms (2)

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

Hand sanitizer and hand washingOTHER

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

Individuals with Atopic DermatitisNon-Atopic Individuals

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Individuals with atopic dermatitis, ages 18-60 years old.
  • Individuals with no history of atopic dermatitis, contact dermatitis, food allergy, asthma, or allergic rhinitis.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skin tape strips will be analyzed for lipid, proteins, and filaggrin breakdown products.

MeSH Terms

Conditions

Skin AbnormalitiesDermatitis, AtopicEczema

Interventions

Hand SanitizersHand Disinfection

Condition Hierarchy (Ancestors)

Congenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, GeneticGenetic Diseases, InbornDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents, LocalAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesDisinfectantsSpecialty Uses of ChemicalsHand HygieneHygienePublic HealthEnvironment and Public Health

Study Officials

  • Jessica Hui, MD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Hui, MD

CONTACT

3033981728huij@njhealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 25, 2020

Study Start

December 1, 2020

Primary Completion

August 20, 2021

Study Completion

August 20, 2021

Last Updated

March 2, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)