Atopic DermatitisNCT04001855
Evaluating the Effect of Bathing Additives in Atopic Dermatitis
A study testing Dilute vinegar (acetic acid) and Dilute bleach in people with Atopic Dermatitis and Eczema, run by University of Arizona at 1 site in United States.
Trial summary
This proposed project will be an open-label, split-arm, randomized controlled pilot study. Up to 60 patients diagnosed with atopic dermatitis (eczema) will be enrolled in the study. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- Dilute vinegar (acetic acid) and Dilute bleach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 31 May 2020
- Phase
- Interventional
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females, at least 5 years of age
- Subjects, parents/legal guardians must be able to comprehend and read the English language
- Subjects must have a diagnosis of atopic dermatitis (AD) by a board-certified dermatologist
Who cannot join
- Subjects who do not fit the inclusion criteria
- Subjects unable or unwilling to comply with the study procedures
- Concurrently have other inflammatory skin conditions
- Prior known allergies to any components of the materials used
- A subject who in the opinion of the investigator will be uncooperative or unable to comply with study procedures
- Subject unable to speak or read the English language
- Those that are pregnant, prisoners or cognitively impaired
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medicine Dermatology
Tucson, Arizona, 85718
About this study
This proposed project will be an open-label, split-arm, randomized controlled pilot study. Up to 60 patients diagnosed with atopic dermatitis (eczema) will be enrolled in the study. The purpose of this study is to understand the change in skin barrier function and skin microbial composition in patients with atopic dermatitis following dilute bleach bath/soak and dilute vinegar bath/soak.
Read the detailed description
Atopic dermatitis (AD), also known as eczema, is an inflammatory skin condition that affects children and adults and causes skin redness, dryness and itching. Dilute bleach baths are standard of care for treatment of AD and work to decrease skin inflammation and modulate the skin microbiome. Dilute vinegar (acetic acid) has been reported to have similar effects on the skin. The purpose of this study is to evaluate the change in skin barrier function and skin microbial composition following baths or gauze soaks with dilute bleach and dilute vinegar.
- Conditions
- Atopic Dermatitis, Eczema
- Being tested
- Dilute vinegar (acetic acid), Dilute bleach
- Keywords
- Atopic Dermatitis, Eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilute vinegar (acetic acid)Other
Dilute vinegar baths or gauze soaks
Dilute bleachOther
Dilute bleach baths or gauze soaks
| Study group | Role | What they receive |
|---|---|---|
| Dilute vinegar vs. dilute bleach bath | Experimental | Subjects will complete a total of 5 study visits over 11 days. At visits 1-4, subjects will soak their forearms in either dilute bleach or dilute vinegar for 10 minutes. At all visits, measurements of skin barrier function will be obtained using non-invasive, commercially-available devices. Non-invasive, non-painful tape stripping samples and skin culture swabs will also be collected. Receives: Other: Dilute vinegar (acetic acid); Other: Dilute bleach |
| Dilute vinegar vs. dilute bleach gauze soaks | Experimental | Subjects will complete a total of two study visits over 21 days, and will be instructed to apply gauze soaks daily at home over the 21-day study period. At baseline and 21-day follow-up visits, measurements of skin barrier function will be obtained using non-invasive, commercially-available devices. Non-invasive, non-painful tape stripping samples and skin culture swabs will also be collected. Subjects will also be provided with a non-invasive skin barrier measurement device to take daily recordings at home. Receives: Other: Dilute vinegar (acetic acid); Other: Dilute bleach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin barrier function - Transepidermal water loss (TEWL)
Assess skin barrier function through measurement of transepidermal water loss (in g/m^2h) using a commercially-available, non-invasive device (Delfin VapoMeter: http://www.delfintech.com/en/product_information/vapometer/).
Measured: Up to 21 days
Skin barrier function - Stratum corneum hydration
Assess skin barrier function through measurement of stratum corneum hydration (in arbitrary units) using a commercially-available, non-invasive device (Delfin MoistureMeterSC: http://www.delfintech.com/en/product_information/moisturemetersc/).
Measured: Up to 21 days
Skin barrier function - pH
Assess skin barrier function through measurement of stratum corneum pH (in pH units) using a commercially-available, non-invasive device.
Measured: Up to 21 days
Skin culture swab
Assess microbial composition via collection of non-invasive, non-painful skin culture swab samples.
Measured: Up to 21 days
Change in Eczema Area and Severity Index (EASI)
Clinical grading of atopic dermatitis/eczema severity (higher EASI scores indicating more severe AD).
Measured: Up to 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Jul 2019
- Primary completion31 May 2020
- Study completion31 May 2020
Why it stopped: Investigator left university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control split body study
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001855
- Sponsor's protocol ID
- 1906687954
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2019
- Last updated
- 4 Jun 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 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Bathing Additives in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04001855
- Acronym / sponsor ID
- 1906687954
- Conditions
- Atopic Dermatitis, Eczema
- Keywords
- Atopic Dermatitis, Eczema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left university
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 28 Jun 2019 (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.
This proposed project will be an open-label, split-arm, randomized controlled pilot study. Up to 60 patients diagnosed with atopic dermatitis (eczema) will be enrolled in the study. The purpose of this study is to understand the change in skin barrier function and skin microbial composition in patients with atopic dermatitis following dilute bleach bath/soak and dilute vinegar bath/soak.
Detailed description
Atopic dermatitis (AD), also known as eczema, is an inflammatory skin condition that affects children and adults and causes skin redness, dryness and itching. Dilute bleach baths are standard of care for treatment of AD and work to decrease skin inflammation and modulate the skin microbiome. Dilute vinegar (acetic acid) has been reported to have similar effects on the skin. The purpose of this study is to evaluate the change in skin barrier function and skin microbial composition following baths or gauze soaks with dilute bleach and dilute vinegar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control split body study
| Arm | Type | Receives |
|---|---|---|
| Dilute vinegar vs. dilute bleach bath | Experimental | Other: Dilute vinegar (acetic acid), Other: Dilute bleachSubjects will complete a total of 5 study visits over 11 days. At visits 1-4, subjects will soak their forearms in either dilute bleach or dilute vinegar for 10 minutes. At all visits, measurements of skin barrier function will be obtained using non-invasive, commercially-available devices. Non-invasive, non-painful tape stripping samples and skin culture swabs will also be collected. |
| Dilute vinegar vs. dilute bleach gauze soaks | Experimental | Other: Dilute vinegar (acetic acid), Other: Dilute bleachSubjects will complete a total of two study visits over 21 days, and will be instructed to apply gauze soaks daily at home over the 21-day study period. At baseline and 21-day follow-up visits, measurements of skin barrier function will be obtained using non-invasive, commercially-available devices. Non-invasive, non-painful tape stripping samples and skin culture swabs will also be collected. Subjects will also be provided with a non-invasive skin barrier measurement device to take daily recordings at home. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females, at least 5 years of age
- Subjects, parents/legal guardians must be able to comprehend and read the English language
- Subjects must have a diagnosis of atopic dermatitis (AD) by a board-certified dermatologist
Key exclusion criteria (7 listed)
- Subjects who do not fit the inclusion criteria
- Subjects unable or unwilling to comply with the study procedures
- Concurrently have other inflammatory skin conditions
- Prior known allergies to any components of the materials used
- A subject who in the opinion of the investigator will be uncooperative or unable to comply with study procedures
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 |
|---|---|---|
| Dilute vinegar (acetic acid)Dilute vinegar baths or gauze soaks | Other | Dilute vinegar vs. dilute bleach bath, Dilute vinegar vs. dilute bleach gauze soaks |
| Dilute bleachDilute bleach baths or gauze soaks | Other | Dilute vinegar vs. dilute bleach bath, Dilute vinegar vs. dilute bleach gauze soaks |
Primary outcome
Skin barrier function - Transepidermal water loss (TEWL)
Time frame: Up to 21 days
Assess skin barrier function through measurement of transepidermal water loss (in g/m^2h) using a commercially-available, non-invasive device (Delfin VapoMeter: http://www.delfintech.com/en/product_information/vapometer/).
Skin barrier function - Stratum corneum hydration
Time frame: Up to 21 days
Assess skin barrier function through measurement of stratum corneum hydration (in arbitrary units) using a commercially-available, non-invasive device (Delfin MoistureMeterSC: http://www.delfintech.com/en/product_information/moisturemetersc/).
Skin barrier function - pH
Time frame: Up to 21 days
Assess skin barrier function through measurement of stratum corneum pH (in pH units) using a commercially-available, non-invasive device.
Skin culture swab
Time frame: Up to 21 days
Assess microbial composition via collection of non-invasive, non-painful skin culture swab samples.
Change in Eczema Area and Severity Index (EASI)
Time frame: Up to 21 days.
Clinical grading of atopic dermatitis/eczema severity (higher EASI scores indicating more severe AD).
Results and safety
The study was stopped early (reason given: Investigator left university). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dilute vinegar (acetic acid) and Dilute bleach in people with Atopic Dermatitis and Eczema, run by University of Arizona 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 7 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: stopped early, as of the sponsor's last update on 4 Jun 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?
The study was stopped early (reason given: Investigator left university). Results are not available in the source record.
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?
Skin barrier function - Transepidermal water loss (TEWL) (time frame: Up to 21 days). The study lists 5 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 4 Jun 2021.