Atopic DermatitisASPIRENCT03775590
The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis
A study testing Water, Bleach and Acetic acid in people with Atopic Dermatitis and Eczema, run by Mayo Clinic at 2 sites in United States.
Trial summary
To evaluate the efficacy of water bath, water + bleach, and water + vinegar (acetic acid) in the treatment of atopic dermatitis (eczema) Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Atopic Dermatitis, Eczema
- What is being tested?
- Water, Bleach and Acetic acid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Feb 2019to 15 Sep 2019
- 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 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Currently reside in the USA
- Ability to comply with follow up visits at 2-4 months and at 6 months
- Come to the last follow-up at 6 months in the clinic
- At least 5% Body Surface Area (BSA) affected with AD
Who cannot join
- Unclear diagnosis of atopic dermatitis
- Inability to comply with additive baths
- Inability to comply with follow-up visits
- Lack of residence in the United States
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
HealthPartners
Saint Paul, Minnesota, 55130
About this study
To evaluate the efficacy of water bath, water + bleach, and water + vinegar (acetic acid) in the treatment of atopic dermatitis (eczema)
Read the detailed description
To perform a randomized controlled study to evaluate the efficacy of adding dilute acetic acid to the bath twice weekly on the Eczema Area and Severity Index (EASI) score as compared to adding dilute bleach to the bath including a control arm in which no solution is added to the bath.
- Conditions
- Atopic Dermatitis, Eczema
- Being tested
- Water, Bleach, Acetic acid
- 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.
WaterProcedure or surgery
To evaluate using water in the treatment of atopic dermatitis
BleachProcedure or surgery
To evaluate using water + dilute bleach in the treatment of atopic dermatitis
Acetic acidProcedure or surgery
Also called vinegar
To evaluate using water + vinegar in the treatment of atopic dermatitis
| Study group | Role | What they receive |
|---|---|---|
| Water | Active comparator | Subjects will bathe at least twice a week in a water bath for 6 months and keep a record of their bathing regimen Receives: Procedure: Water |
| Bleach | Active comparator | Subjects will bathe at least twice a week in a water + dilute bleach bath for 6 months and keep a record of their bathing regimen Receives: Procedure: Bleach |
| Acetic acid | Active comparator | Subjects will bathe at least twice a week in a water bath + vinegar for 6 months and keep a record of their bathing regimen Receives: Procedure: Acetic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index (EASI) score improvement from baseline
The EASI score is a validated composite score that ranges from 0 (clear) to 72 (very severe). The EASI is assessed and calculated as: the proportion of affected body surface area (BSA) was estimated from 4 designated body regions (head/neck, upper limbs, trunk, and lower limbs), and the Physician's Assessment of Individual Signs was determined for each region. The Physician's Assessment of Individual Signs grades signs of AD (erythema, edema/induration/papulation, excoriation, oozing/weeping/crusting, scaling, and lichenification) on a 4-point scale, ranging from absent to severe. Both the proportion of affected BSA and the Physician's Assessment of Individual Signs score are used to calculate the EASI score.
Measured: At each visit until the last visit at 6 months
Secondary outcomes (8)
Patient Oriented Eczema Measure (POEM)
The POEM measures the severity of eczema from a scale of 0-28 with 0 being clear and 28 as having severe eczema.
- 0 to 2 = Clear or almost clear
- 3 to 7 = Mild eczema
- 8 to 16 = Moderate eczema
- 17 to 24 = Severe eczema
- 25 to 28 = Very severe eczema
Measured: At each visit until the last visit at 6 months
Infant Dermatitis Quality of Life (IDQOL) for children under 4 years old
This quality of life (QoL) measures the patient quality of life from 0 - 30 with 0 being the patient's eczema doesn't have an affect on the patient's QoL while 30 means it has a profound effect on the patient's QoL.
Measured: At each visit until the last visit at 6 months
Children's Dermatitis Quality of Life Index (CDQLI) for children at 4 years old or greater
This quality of life (QoL) measures the patient quality of life from 0 - 30 with 0 being the patient's eczema doesn't have an affect on the patient's QoL while 30 means it has a profound effect on the patient's QoL.
Measured: At each visit until the last visit at 6 months
Rate of oral antibiotic prescribing
The number of oral courses of antibiotics given for skin related concerns at 2-4 months and at 6 months in each group.
Measured: At each visit until the last visit at 6 months
Presence of staphylococcus aureus on involved skin
Differences in S. aureus colonization rates between each study arm at 2-4 months and at 6 months.
Measured: At each visit until the last visit at 6 months
Changes in Investigator's Global Assessment (IGA) score from baseline
The IGA score (clear, almost clear, mild, moderate, severe, very severe; on numbered scaled where 0 = clear and 5 = very severe) at each visit
Measured: At each visit until the last visit at 6 months
Frequency and severity of atopic dermatitis flares
Number and severity of flares in each group within 2-4 months and within 6 months
Measured: At each visit until the last visit at 6 months
pH of the skin
Differences between the pH of the skin between the three study arms at 2-4 months and at 6 months
Measured: At each visit until the last visit at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start21 Feb 2019
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Why it stopped: Study closed due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- There are 3 study arms with 50 subjects in each arm. The 3 arms are: water, water + bleach, and water + vinegar
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- HealthPartners Institute
- Responsible party
- Principal investigator, Megha M. Tollefson, M.D., Mayo Clinic
- Investigators
- Megha M Tollefson, MD, Principal investigator, Mayo ClinicSarah Asch, MD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775590
- Sponsor's protocol ID
- 18-006224
- Acronym
- ASPIRE
- Status last verified
- May 2021
- First submitted
- 6 Nov 2018
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.
PubMed 24813302Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217.
PubMed 19403473Hon KL, Tsang YC, Lee VW, Pong NH, Ha G, Lee ST, Chow CM, Leung TF. Efficacy of sodium hypochlorite (bleach) baths to reduce Staphylococcus aureus colonization in childhood onset moderate-to-severe eczema: A randomized, placebo-controlled cross-over trial. J Dermatolog Treat. 2016;27(2):156-62. doi: 10.3109/09546634.2015.1067669. Epub 2015 Aug 13.
PubMed 26270469Gonzalez ME, Schaffer JV, Orlow SJ, Gao Z, Li H, Alekseyenko AV, Blaser MJ. Cutaneous microbiome effects of fluticasone propionate cream and adjunctive bleach baths in childhood atopic dermatitis. J Am Acad Dermatol. 2016 Sep;75(3):481-493.e8. doi: 10.1016/j.jaad.2016.04.066.
PubMed 27543211Eichenfield LF, Tom WL, Chamlin SL, Feldman SR, Hanifin JM, Simpson EL, Berger TG, Bergman JN, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Krol A, Margolis DJ, Paller AS, Schwarzenberger K, Silverman RA, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014 Feb;70(2):338-51. doi: 10.1016/j.jaad.2013.10.010. Epub 2013 Nov 27.
PubMed 24290431
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Bathing Additives in the Treatment of Pediatric Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03775590
- Acronym / sponsor ID
- ASPIRE / 18-006224
- Conditions
- Atopic Dermatitis, Eczema
- Keywords
- Atopic Dermatitis, Eczema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to lack of enrollment.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- HealthPartners Institute
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 14 Dec 2018 (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.
To evaluate the efficacy of water bath, water + bleach, and water + vinegar (acetic acid) in the treatment of atopic dermatitis (eczema)
Detailed description
To perform a randomized controlled study to evaluate the efficacy of adding dilute acetic acid to the bath twice weekly on the Eczema Area and Severity Index (EASI) score as compared to adding dilute bleach to the bath including a control arm in which no solution is added to the bath.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- There are 3 study arms with 50 subjects in each arm. The 3 arms are: water, water + bleach, and water + vinegar
| Arm | Type | Receives |
|---|---|---|
| Water | Active comparator | Procedure: WaterSubjects will bathe at least twice a week in a water bath for 6 months and keep a record of their bathing regimen |
| Bleach | Active comparator | Procedure: BleachSubjects will bathe at least twice a week in a water + dilute bleach bath for 6 months and keep a record of their bathing regimen |
| Acetic acid | Active comparator | Procedure: Acetic acidSubjects will bathe at least twice a week in a water bath + vinegar for 6 months and keep a record of their bathing regimen |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Currently reside in the USA
- Ability to comply with follow up visits at 2-4 months and at 6 months
- Come to the last follow-up at 6 months in the clinic
- At least 5% Body Surface Area (BSA) affected with AD
Key exclusion criteria (4 listed)
- Unclear diagnosis of atopic dermatitis
- Inability to comply with additive baths
- Inability to comply with follow-up visits
- Lack of residence in the United States
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 |
|---|---|---|
| WaterTo evaluate using water in the treatment of atopic dermatitis | Procedure or surgery | Water |
| BleachTo evaluate using water + dilute bleach in the treatment of atopic dermatitis | Procedure or surgery | Bleach |
| Acetic acidAlso: vinegarTo evaluate using water + vinegar in the treatment of atopic dermatitis | Procedure or surgery | Acetic acid |
Primary outcome
Eczema Area and Severity Index (EASI) score improvement from baseline
Time frame: At each visit until the last visit at 6 months
The EASI score is a validated composite score that ranges from 0 (clear) to 72 (very severe). The EASI is assessed and calculated as: the proportion of affected body surface area (BSA) was estimated from 4 designated body regions (head/neck, upper limbs, trunk, and lower limbs), and the Physician's Assessment of Individual Signs was determined for each region. The Physician's Assessment of Individual Signs grades signs of AD (erythema, edema/induration/papulation, excoriation, oozing/weeping/crusting, scaling, and lichenification) on a 4-point scale, ranging from absent to severe. Both the proportion of affected BSA and the Physician's Assessment of Individual Signs score are used to calculate the EASI score.
8 secondary outcomes
Patient Oriented Eczema Measure (POEM)
Time frame: At each visit until the last visit at 6 months
Infant Dermatitis Quality of Life (IDQOL) for children under 4 years old
Time frame: At each visit until the last visit at 6 months
Children's Dermatitis Quality of Life Index (CDQLI) for children at 4 years old or greater
Time frame: At each visit until the last visit at 6 months
Rate of oral antibiotic prescribing
Time frame: At each visit until the last visit at 6 months
Presence of staphylococcus aureus on involved skin
Time frame: At each visit until the last visit at 6 months
Changes in Investigator's Global Assessment (IGA) score from baseline
Time frame: At each visit until the last visit at 6 months
Frequency and severity of atopic dermatitis flares
Time frame: At each visit until the last visit at 6 months
pH of the skin
Time frame: At each visit until the last visit at 6 months
Results and safety
The study was stopped early (reason given: Study closed due to lack of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Background: PubMed 24813302Eichenfield LF, Tom WL, Berger TG, Krol A, Paller AS, Schwarzenberger K, Bergman JN, Chamlin SL, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Margolis DJ, Silverman RA, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014 Jul;71(1):116-32. doi: 10.1016/j.jaad.2014.03.023. Epub 2014 May 9.
- Background: PubMed 19403473Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217.
- Background: PubMed 26270469Hon KL, Tsang YC, Lee VW, Pong NH, Ha G, Lee ST, Chow CM, Leung TF. Efficacy of sodium hypochlorite (bleach) baths to reduce Staphylococcus aureus colonization in childhood onset moderate-to-severe eczema: A randomized, placebo-controlled cross-over trial. J Dermatolog Treat. 2016;27(2):156-62. doi: 10.3109/09546634.2015.1067669. Epub 2015 Aug 13.
- Background: PubMed 27543211Gonzalez ME, Schaffer JV, Orlow SJ, Gao Z, Li H, Alekseyenko AV, Blaser MJ. Cutaneous microbiome effects of fluticasone propionate cream and adjunctive bleach baths in childhood atopic dermatitis. J Am Acad Dermatol. 2016 Sep;75(3):481-493.e8. doi: 10.1016/j.jaad.2016.04.066.
- Background: PubMed 24290431Eichenfield LF, Tom WL, Chamlin SL, Feldman SR, Hanifin JM, Simpson EL, Berger TG, Bergman JN, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Krol A, Margolis DJ, Paller AS, Schwarzenberger K, Silverman RA, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014 Feb;70(2):338-51. doi: 10.1016/j.jaad.2013.10.010. Epub 2013 Nov 27.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Megha M Tollefson, MD principal investigator
Mayo Clinic
Sarah Asch, MD principal investigator
HealthPartners Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water, Bleach and Acetic acid in people with Atopic Dermatitis and Eczema, run by Mayo Clinic at 2 sites 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 4 inclusion and 4 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 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: Study closed due to lack of enrollment.). 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?
Eczema Area and Severity Index (EASI) score improvement from baseline (time frame: At each visit until the last visit at 6 months). 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 NCT03775590, which also lists 5 linked publications.
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 12 May 2021.