Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000215022
Ethics application status
Not yet submitted
Date submitted
11/03/2010
Date registered
16/03/2010
Date last updated
16/03/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Bleach baths for atopic eczema
Scientific title
The effect of diluted bleach baths in reducing severity of atopic eczema in infants, children and adolescents compared with emollient baths.
Secondary ID [1] 1490 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic eczema 256954 0
Condition category
Condition code
Skin 257096 257096 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the treatment arm will be asked to bathe in dilute bleach baths everyday for 1 week, then 3 times a week for 23 weeks. Participants will continue standard treatments for managing eczema.
Standard treatments for managing eczema include bathing daily with an emollient (other than the study emollient) added, application of moisturiser at least twice a day, the use of topical corticosteriods to eczema areas, and systemic antibiotics and wet dressings as required.
Intervention code [1] 256131 0
Treatment: Other
Comparator / control treatment
Participants in the control arm will be asked to bath in study emollient baths everyday for 1 week, then 3 times a week for 23 weeks. Participants will continue standard treatments for managing eczema.
Control group
Active

Outcomes
Primary outcome [1] 257987 0
Severity of eczema will be assessed by a blinded outcome assessor using the SCORing of Atopic Eczema (SCORAD) index.
Timepoint [1] 257987 0
Initial visit, 4 weeks, 12 weeks, 24 weeks.
Secondary outcome [1] 263541 0
Eradication of staphylococcal aureus will assessed by taking bacterial cultures and culture sensitivities from skin swabs of the nose, axilla and worst eczematous lesion. Eradication will be defined as no growth in 48 hours.
Timepoint [1] 263541 0
Initial visit, 4 weeks, 12 weeks, 24 weeks
Secondary outcome [2] 263542 0
Use of systemic antibiotics will be assessed by asking the participant/caregiver the number of completed courses of systemic antibiotics that were taken over the study period.
Timepoint [2] 263542 0
4 weeks, 12 weeks, 24 weeks
Secondary outcome [3] 263543 0
Tolerability of bleach baths will be assed by documenting the incidence of adverese events of interest to the dilute bleach baths. Reports will be rated by asking participants/caregivers to rate the level of stinging using a 5-point scale.
Timepoint [3] 263543 0
4 weeks, 12 weeks, 24 weeks

Eligibility
Key inclusion criteria
aged between 6 months and 18 years, moderate to severe atopic eczema (SCORAD >25) at time of randomisation
Minimum age
6 Months
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known allergies to bleach or liquid paraffin, treatment with bleach baths, salt baths, antispectic oils or antibiotics 4 weeks prior to randomisation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed, opaque envelopes sequentially numbered, prepared by independent statistician, as participant is enrolled the investigator will allocate them a study number by selecting the next envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256631 0
Hospital
Name [1] 256631 0
Royal Children's Hospital
Country [1] 256631 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
50 Flemington Rd, Parkville, Victoria
Country
Australia
Secondary sponsor category [1] 255919 0
None
Name [1] 255919 0
Address [1] 255919 0
Country [1] 255919 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258658 0
Ethics committee address [1] 258658 0
Ethics committee country [1] 258658 0
Date submitted for ethics approval [1] 258658 0
15/03/2010
Approval date [1] 258658 0
Ethics approval number [1] 258658 0

Summary
Brief summary
Eczema is a skin condition which affects the lives of many children and their families. Skin infections are common in people with eczema and can often make the eczema worse. The skin of people with eczema often contains high numbers of bacteria called Staphylococcus aureus. Lots of eczema treatments have been developed to reduce Staphylococcus aureus however it is not clear how well these treatments work.
Household bleach has been safely used for many years to help treat infected wounds after surgery. Recently it has been recommended for people with eczema to help reduce Staphylococcus aureus. Although it is being recommended for people with eczema there is little long-term evidence to show if household bleach is effective in improving eczema.
We want to see if there is an improvement in eczema in children who add a small amount of bleach solution to their bath. We will compare them to a group of children who add bath oil to their bath. The results of this project may influence the care of eczema in the future.
We hope 74 children who have moderate to severe eczema will take part in this project. Thirty-seven children will be asked to add a small amount of bleach solution to their bath and the other 37 children will be asked to add bath oil to their bath. The project will run for 6 months. The project will measure the severity of eczema before and after using the bleach solution or bath oil.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30920 0
Address 30920 0
Country 30920 0
Phone 30920 0
Fax 30920 0
Email 30920 0
Contact person for public queries
Name 14167 0
Elizabeth Leins
Address 14167 0
Royal Children's Hospital, 50 Flemington Rd, Parkville, Victoria, 3052
Country 14167 0
Australia
Phone 14167 0
+61 3 9345 5522 pager 4735
Fax 14167 0
Email 14167 0
liz.leins@rch.org.au
Contact person for scientific queries
Name 5095 0
Elizabeth Leins
Address 5095 0
Royal Children's Hospital, 50 Flemington Rd, Parkville, Victoria, 3052
Country 5095 0
Australia
Phone 5095 0
+61 3 9345 5522 pager 4735
Fax 5095 0
Email 5095 0
liz.leins@rch.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBleach baths for atopic dermatitis: A systematic review and meta-analysis including unpublished data, Bayesian interpretation, and GRADE.2022https://dx.doi.org/10.1016/j.anai.2022.03.024
N.B. These documents automatically identified may not have been verified by the study sponsor.