Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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.
Query!
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)?
Query!
Secondary ID [1]
259761
0
Nil
Query!
Universal Trial Number (UTN)
U1111-1119-8112
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Eczema
261335
0
Query!
Bacterial Colonisation of the Skin
261336
0
Query!
Condition category
Condition code
Skin
259483
259483
0
0
Query!
Dermatological conditions
Query!
Infection
259484
259484
0
0
Query!
Studies of infection and infectious agents
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
264181
0
Treatment: Other
Query!
Comparator / control treatment
Water baths.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
262293
0
Eczema Area and Severity Index (EASI).
Query!
Assessment method [1]
262293
0
Query!
Timepoint [1]
262293
0
After six weeks of twice weekly baths.
Query!
Secondary outcome [1]
273476
0
Scoring Atopic Dermatitis (SCORAD).
Query!
Assessment method [1]
273476
0
Query!
Timepoint [1]
273476
0
After six weeks of twice weekly baths.
Query!
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.
Query!
Assessment method [2]
273477
0
Query!
Timepoint [2]
273477
0
After six weeks of twice weekly baths.
Query!
Eligibility
Key inclusion criteria
Children with Eczema (Atopic Dermatitis)
Query!
Minimum age
1
Years
Query!
Query!
Maximum age
15
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
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.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
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.
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/04/2011
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
64
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
3296
0
New Zealand
Query!
State/province [1]
3296
0
Query!
Funding & Sponsors
Funding source category [1]
264627
0
Self funded/Unfunded
Query!
Name [1]
264627
0
Dr Michael Herd
Query!
Address [1]
264627
0
Paediatric Department, Rangitira Unit, Waitakere Hospital. 55-75 Lincoln Road Henderson Auckland 0610
Query!
Country [1]
264627
0
New Zealand
Query!
Primary sponsor type
Individual
Query!
Name
Dr Michael Herd
Query!
Address
Paediatric Department, Rangitira Unit, Waitakere Hospital. 55-75 Lincoln Road Henderson Auckland 0610
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
263767
0
None
Query!
Name [1]
263767
0
Query!
Address [1]
263767
0
Query!
Country [1]
263767
0
Query!
Other collaborator category [1]
251861
0
Individual
Query!
Name [1]
251861
0
Dr Sharon Wong
Query!
Address [1]
251861
0
Paediatric Department, Rangitira Unit, Waitakere Hospital. 55-75 Lincoln Road Henderson Auckland 0610
Query!
Country [1]
251861
0
New Zealand
Query!
Other collaborator category [2]
251864
0
Individual
Query!
Name [2]
251864
0
Dr Arun Gangakhedkhar
Query!
Address [2]
251864
0
Paediatric Department, Rangitira Unit, Waitakere Hospital. 55-75 Lincoln Road Henderson Auckland 0610
Query!
Country [2]
251864
0
New Zealand
Query!
Other collaborator category [3]
251865
0
Individual
Query!
Name [3]
251865
0
Carolyn Cordes
Query!
Address [3]
251865
0
Paediatric Department, Rangitira Unit, Waitakere Hospital. 55-75 Lincoln Road Henderson Auckland 0610
Query!
Country [3]
251865
0
New Zealand
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
266631
0
Northern X Regional Ethics Committee
Query!
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
Query!
Ethics committee country [1]
266631
0
New Zealand
Query!
Date submitted for ethics approval [1]
266631
0
15/02/2011
Query!
Approval date [1]
266631
0
24/03/2011
Query!
Ethics approval number [1]
266631
0
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
32323
0
Query!
Address
32323
0
Query!
Country
32323
0
Query!
Phone
32323
0
Query!
Fax
32323
0
Query!
Email
32323
0
Query!
Contact person for public queries
Name
15570
0
Dr Michael Herd
Query!
Address
15570
0
Paediatric Department, Rangitira Unit, Waitakere Hospital. 55-75 Lincoln Road Henderson Auckland 0610
Query!
Country
15570
0
New Zealand
Query!
Phone
15570
0
6421869575
Query!
Fax
15570
0
Query!
Email
15570
0
[email protected]
Query!
Contact person for scientific queries
Name
6498
0
Dr Michael Herd
Query!
Address
6498
0
Paediatric Department, Rangitira Unit, Waitakere Hospital. 55-75 Lincoln Road Henderson Auckland 0610
Query!
Country
6498
0
New Zealand
Query!
Phone
6498
0
64273454877
Query!
Fax
6498
0
Query!
Email
6498
0
[email protected]
Query!
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
No additional documents have been identified.
Download to PDF