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Trial registered on ANZCTR


Registration number
ACTRN12611000260921
Ethics application status
Approved
Date submitted
8/03/2011
Date registered
10/03/2011
Date last updated
14/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Placebo-Controlled Trial to compare Dilute Bleach Baths with Water treatment of Children with Eczema.
Scientific title
When Children with Eczema are treated with Dilute Bleach baths and they are compared with Children with Eczema who have Water baths is there a difference in the Eczema as measured by the Eczema Area and Severity Index (EASI)?
Secondary ID [1] 259761 0
Nil
Universal Trial Number (UTN)
U1111-1119-8112
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eczema 261335 0
Bacterial Colonisation of the Skin 261336 0
Condition category
Condition code
Skin 259483 259483 0 0
Dermatological conditions
Infection 259484 259484 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twice weekly dilute bleach baths for six weeks.

Add 1 ml of household bleach per litre of bath water.

This results in Sodium hypochlorite 0.004% concentration in the bath water.
Intervention code [1] 264181 0
Treatment: Other
Comparator / control treatment
Water baths.
Control group
Active

Outcomes
Primary outcome [1] 262293 0
Eczema Area and Severity Index (EASI).
Timepoint [1] 262293 0
After six weeks of twice weekly baths.
Secondary outcome [1] 273476 0
Scoring Atopic Dermatitis (SCORAD).
Timepoint [1] 273476 0
After six weeks of twice weekly baths.
Secondary outcome [2] 273477 0
Bacterial Colonisation of the Skin and Nostrils.

This is assessed by taking swabs from any inflamed areas of skin and also one swab from the nostrils. The swabs will be processed by Waitakere Hospital laboratory using standard plating methods used in medical laboratories.
Timepoint [2] 273477 0
After six weeks of twice weekly baths.

Eligibility
Key inclusion criteria
Children with Eczema (Atopic Dermatitis)
Minimum age
1 Years
Maximum age
15 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous use of antibiotics in the 6 weeks prior to enrolment in the trial.

Previous allergic reaction or severe exacerbation of asthma after contact with bleach.

Children who do not have a family doctor to help monitor progress whilst in the trial.

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)
Children referred to Waitakere Hospital Paediatric Outpatients (a General Paediatric Clinic) with Eczema will be offered a place in the trial.

Treatment with bleach or water will allocated at random in plain numbered bottles of either bleach or water to be added to the bath. Because bleach has a smell, we cannot blind the patient and their parents to the treatment they have been allocated to. Medical and Nursing staff following the progress of the children will be blinded to the child's treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used by the Hospital pharmacist to allocate either Bleach or water to participants in the trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Initial EASI and SCORAD will be assessed prior to randomisation. There will be blinded assessment of the EASI score and SCORAD score after six weeks of twice weekly baths.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3296 0
New Zealand
State/province [1] 3296 0

Funding & Sponsors
Funding source category [1] 264627 0
Self funded/Unfunded
Name [1] 264627 0
Dr Michael Herd
Address [1] 264627 0
Paediatric Department, Rangitira Unit, Waitakere Hospital. 55-75 Lincoln Road Henderson Auckland 0610
Country [1] 264627 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michael Herd
Address
Paediatric Department, Rangitira Unit, Waitakere Hospital. 55-75 Lincoln Road Henderson Auckland 0610
Country
New Zealand
Secondary sponsor category [1] 263767 0
None
Name [1] 263767 0
Address [1] 263767 0
Country [1] 263767 0
Other collaborator category [1] 251861 0
Individual
Name [1] 251861 0
Dr Sharon Wong
Address [1] 251861 0
Paediatric Department, Rangitira Unit, Waitakere Hospital. 55-75 Lincoln Road Henderson Auckland 0610
Country [1] 251861 0
New Zealand
Other collaborator category [2] 251864 0
Individual
Name [2] 251864 0
Dr Arun Gangakhedkhar
Address [2] 251864 0
Paediatric Department, Rangitira Unit, Waitakere Hospital. 55-75 Lincoln Road Henderson Auckland 0610
Country [2] 251864 0
New Zealand
Other collaborator category [3] 251865 0
Individual
Name [3] 251865 0
Carolyn Cordes
Address [3] 251865 0
Paediatric Department, Rangitira Unit, Waitakere Hospital. 55-75 Lincoln Road Henderson Auckland 0610
Country [3] 251865 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266631 0
Northern X Regional Ethics Committee
Ethics committee address [1] 266631 0
Ministry of Health
3rd Floor Unisys Building
650 Great South Road, Penrose
Private Bag 92 522
Wellesley Street, Auckland 1061
Ethics committee country [1] 266631 0
New Zealand
Date submitted for ethics approval [1] 266631 0
15/02/2011
Approval date [1] 266631 0
24/03/2011
Ethics approval number [1] 266631 0

Summary
Brief summary
A trial to compare twice weekly dilute bleach baths with water baths in children with eczema. The hypothesis is that bacterial colonisation may be less after the bleach baths and so the eczema should improve. Bacterial swabs will also be taken at the start and after six weeks of baths to assess bacterial colonisation rates before and after the dilute bleach baths. The amount of bleach used is 1 ml per litre of bath water (giving Sodium hypochlorite 0.004% in the bath water). All participants will also have standard eczema treatments with moisturisers and steroid creams as required.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32323 0
Address 32323 0
Country 32323 0
Phone 32323 0
Fax 32323 0
Email 32323 0
Contact person for public queries
Name 15570 0
Dr Michael Herd
Address 15570 0
Paediatric Department, Rangitira Unit, Waitakere Hospital. 55-75 Lincoln Road Henderson Auckland 0610
Country 15570 0
New Zealand
Phone 15570 0
6421869575
Fax 15570 0
Email 15570 0
michael.herd@waitematadhb.govt.nz
Contact person for scientific queries
Name 6498 0
Dr Michael Herd
Address 6498 0
Paediatric Department, Rangitira Unit, Waitakere Hospital. 55-75 Lincoln Road Henderson Auckland 0610
Country 6498 0
New Zealand
Phone 6498 0
64273454877
Fax 6498 0
Email 6498 0
mherd@adhb.govt.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary