Dermatitis, AtopicNCT02582788
Bathing Additives in Pediatric Atopic Dermatitis
A study testing Bathing Additive in people with Dermatitis, Atopic, run by Mayo Clinic at 1 site in United States.
Trial summary
The current clinical guidelines for management of atopic dermatitis now recommend bleach baths. This requires simply the addition of regular household bleach to twice-weekly baths. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Bathing Additive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Apr 2018
- 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
- Patients from 6 months to 17 years of age
- Currently residing in US.
- Follow up visits at 1 month, 3 months and 6 months after initiation of treatment in study (Figure 1).
- Last follow-up at 1 year in clinic or via written mailed-out survey.
- Diagnosis of atopic dermatitis AND
- Have active signs of bacterial skin infection OR
Show all 9Show fewer
- Any documented suspected history of bacterial skin infection (weeping, crusting, and/or pustules on exam), OR
- Prescription for oral antibiotics for skin infection in the past 6 months from any provider). OR
- Have been prescribed bleach baths as part of an atopic dermatitis skin care regimen.
Who cannot join
- Superficial skin infection without diagnosis of atopic dermatitis
- Lack of in-clinic follow up assessment at 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Bathing Additives in Management of Pediatric Atopic Dermatitis
The current clinical guidelines for management of atopic dermatitis now recommend bleach baths. This requires simply the addition of regular household bleach to twice-weekly baths. At the Mayo Clinic, dilute acetic acid (vinegar) has been recommended for decades in wet wraps to treat patients hospitalized for their atopic dermatitis. However, this practice has not been widely adopted in the pediatric dermatology community. Will the use of dilute acetic acid (vinegar) in twice weekly baths help manage atopic dermatitis in pediatric patients as well as, or better than, the current accepted guidelines?
- Conditions
- Dermatitis, Atopic
- Being tested
- Bathing Additive
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bathing AdditiveOther
| Study group | Role | What they receive |
|---|---|---|
| Bleach | Active comparator | Patients will use bleach added to their baths twice a week. Receives: Other: Bathing Additive |
| Vinegar | Active comparator | Patients will use vinegar (dilute acetic acid) added to their baths twice a week. Receives: Other: Bathing Additive |
What is being measured
The primary outcome is the main question the study is designed to answer.
EASI score at 6 months
Measured: 6 months
Secondary outcomes (1)
Courses of antibiotics required
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megha M. Tollefson, M.D., Mayo Clinic
- Investigators
- Megha Tollefson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582788
- Sponsor's protocol ID
- 15-003161
- Status last verified
- Aug 2018
- First submitted
- 21 Sep 2015
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bathing Additives in Management of Pediatric Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT02582788
- Acronym / sponsor ID
- 15-003161
- Conditions
- Dermatitis, Atopic
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 21 Oct 2015 (estimated)
- 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.
The current clinical guidelines for management of atopic dermatitis now recommend bleach baths. This requires simply the addition of regular household bleach to twice-weekly baths. At the Mayo Clinic, dilute acetic acid (vinegar) has been recommended for decades in wet wraps to treat patients hospitalized for their atopic dermatitis. However, this practice has not been widely adopted in the pediatric dermatology community. Will the use of dilute acetic acid (vinegar) in twice weekly baths help manage atopic dermatitis in pediatric patients as well as, or better than, the current accepted guidelines?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bleach | Active comparator | Other: Bathing AdditivePatients will use bleach added to their baths twice a week. |
| Vinegar | Active comparator | Other: Bathing AdditivePatients will use vinegar (dilute acetic acid) added to their baths twice a week. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Patients from 6 months to 17 years of age
- Currently residing in US.
- Follow up visits at 1 month, 3 months and 6 months after initiation of treatment in study (Figure 1).
- Last follow-up at 1 year in clinic or via written mailed-out survey.
- Diagnosis of atopic dermatitis AND
Key exclusion criteria (2 listed)
- Superficial skin infection without diagnosis of atopic dermatitis
- Lack of in-clinic follow up assessment at 6 months
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 |
|---|---|---|
| Bathing Additive | Other | Bleach, Vinegar |
Primary outcome
EASI score at 6 months
Time frame: 6 months
1 secondary outcome
Courses of antibiotics required
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
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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 Tollefson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bathing Additive in people with Dermatitis, Atopic, run by Mayo Clinic 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 9 inclusion and 2 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 31 Aug 2018. 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. 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?
EASI score at 6 months (time frame: 6 months). 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 31 Aug 2018.