Moderate to Severe Atopic DermatitisNCT01286220
Dilute Bleach Baths in Pediatric Patients With Atopic Dermatitis
A study testing Dilute bleach baths and Water in people with Moderate to Severe Atopic Dermatitis, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if twice weekly 10 minute dilute bleach baths decreases disease severity in patients with moderate to severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Moderate to Severe Atopic Dermatitis
- What is being tested?
- Dilute bleach baths and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Aug 2017
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 2-17 years of age at time of consent. A parent or legal guardian will be required to consent and authorize their enrollment in the study.
- Male or female of any ethnic background.
- English or Spanish speaking.
- A clinical diagnosis of atopic dermatitis for at least 6 months prior to enrollment.
- Must have moderate to severe atopic dermatitis as rated by the EASI score.
- Able to adhere to study visit schedule and other protocol requirements.
- Patients and/or family members must agree to not use any other prescription or over the counter medications other than the ones prescribed by the study protocol.
Who cannot join
- Clinical evidence of bacterial or viral superinfection on first visit.
- Have received phototherapy within 2 months prior to enrollment.
- Have received any systemic medication for atopic dermatitis or any that may affect evaluation of atopic dermatitis within 2 months prior to enrollment.
- Have a known hypersensitivity response, including anaphylaxis, to any of the topicals used for treatment (i.e. topical steroids, bleach)
- Participation in another clinical trial using an investigational agent or procedure.
- Pregnant or planning pregnancy or surgery during the participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Medical Center of Dallas
Dallas, Texas, 75235
About this study
Official title: A Randomized, Controlled, Evaluator-blinded Study to Evaluate the Efficacy of Dilute Bleach Baths on Skin Disease Control in Pediatric Patients With Atopic Dermatitis
The purpose of this study is to determine if twice weekly 10 minute dilute bleach baths decreases disease severity in patients with moderate to severe atopic dermatitis.
- Conditions
- Moderate to Severe Atopic Dermatitis
- Being tested
- Dilute bleach baths, Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilute bleach bathsOther
Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.
WaterOther
Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Dilute bleach baths | Active comparator | Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes. Receives: Other: Dilute bleach baths |
| Water | Placebo comparator | Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eczema Area and Severity Index Score (EASI)
EASI score is recorded at baseline, 1 month and 3 month follow ups.
Measured: Change in EASI score from baseline at 1 month and 3 month follow ups
Secondary outcomes (1)
Investigator's Global Assessment (IGA)
IGA scores are recorded at baseline, 1 month and 3 month follow ups.
Measured: Change in IGA score from baseline at 1 month and 3month follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionAug 2013
- Study completionAug 2017
Why it stopped: the study was terminated due to participant drop out
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 Moderate to Severe Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Double blind
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Medical Center Dallas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286220
- Sponsor's protocol ID
- STU 012010-059
- Status last verified
- Mar 2020
- First submitted
- 26 Jan 2011
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Huang 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 19403473
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Evaluator-blinded Study to Evaluate the Efficacy of Dilute Bleach Baths on Skin Disease Control in Pediatric Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01286220
- Acronym / sponsor ID
- STU 012010-059
- Conditions
- Moderate to Severe Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study was terminated due to participant drop out
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Children's Medical Center Dallas
- Study start
- Dec 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 31 Jan 2011 (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 purpose of this study is to determine if twice weekly 10 minute dilute bleach baths decreases disease severity in patients with moderate to severe atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dilute bleach baths | Active comparator | Other: Dilute bleach bathsPatients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes. |
| Water | Placebo comparator | Other: WaterPatients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 2-17 years of age at time of consent. A parent or legal guardian will be required to consent and authorize their enrollment in the study.
- Male or female of any ethnic background.
- English or Spanish speaking.
- A clinical diagnosis of atopic dermatitis for at least 6 months prior to enrollment.
- Must have moderate to severe atopic dermatitis as rated by the EASI score.
Key exclusion criteria (6 listed)
- Clinical evidence of bacterial or viral superinfection on first visit.
- Have received phototherapy within 2 months prior to enrollment.
- Have received any systemic medication for atopic dermatitis or any that may affect evaluation of atopic dermatitis within 2 months prior to enrollment.
- Have a known hypersensitivity response, including anaphylaxis, to any of the topicals used for treatment (i.e. topical steroids, bleach)
- Participation in another clinical trial using an investigational agent or procedure.
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 bleach bathsPatients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes. | Other | Dilute bleach baths |
| WaterPatients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes. | Other | Water |
Primary outcome
Eczema Area and Severity Index Score (EASI)
Time frame: Change in EASI score from baseline at 1 month and 3 month follow ups
EASI score is recorded at baseline, 1 month and 3 month follow ups.
1 secondary outcome
Investigator's Global Assessment (IGA)
Time frame: Change in IGA score from baseline at 1 month and 3month follow ups
Results and safety
The study was stopped early (reason given: the study was terminated due to participant drop out). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
- Results publication: 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.
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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 bleach baths and Water in people with Moderate to Severe Atopic Dermatitis, run by University of Texas Southwestern Medical Center 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 7 inclusion and 6 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 20 Mar 2020. 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. Some participants in this study may receive a placebo. 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: the study was terminated due to participant drop out). 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 Score (EASI) (time frame: Change in EASI score from baseline at 1 month and 3 month follow ups). 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 NCT01286220, 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 20 Mar 2020.