ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Atopic eczema

Condition category

Condition code

Skin

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]

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]

Severity of eczema will be assessed by a blinded outcome assessor using the SCORing of Atopic Eczema (SCORAD) index.

Timepoint [1]

Initial visit, 4 weeks, 12 weeks, 24 weeks.

Secondary outcome [1]

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]

Initial visit, 4 weeks, 12 weeks, 24 weeks

Secondary outcome [2]

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]

4 weeks, 12 weeks, 24 weeks

Secondary outcome [3]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Children's Hospital

Address [1]

50 Flemington Rd, Parkville, Victoria 3052

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Children's Hospital

Address

50 Flemington Rd, Parkville, Victoria

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

15/03/2010

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Elizabeth Leins

Address

Royal Children's Hospital, 50 Flemington Rd, Parkville, Victoria, 3052

Country

Australia

Phone

+61 3 9345 5522 pager 4735

Fax

liz.leins@rch.org.au

Contact person for scientific queries

Name

Elizabeth Leins

Address

Royal Children's Hospital, 50 Flemington Rd, Parkville, Victoria, 3052

Country

Australia

Phone

+61 3 9345 5522 pager 4735

Fax

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

Source	Title	Year of Publication	DOI
Embase	Bleach baths for atopic dermatitis: A systematic review and meta-analysis including unpublished data, Bayesian interpretation, and GRADE.	2022	https://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.

Trial Review

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Documents added manually

Documents added automatically