Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00344

2 Trial Registration Date

2012-11-05

i Registration Status

Prospective

3 Secondary IDs

NA

4 Source(s) of Funding

Direc Grant CUHK

5 Primary Sponsor

Hon KL, sponsored by Direct Grant CUHK

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Hon KL

ii Address

Department of Paediatrics, 6/F Prince of Wales Hospital, Shatin

iii Phone

26322859

iv Email

ehon@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Henry Pong

ii Address

Department of Paediatrics, 6/F Prince of Wales Hospital, Shatin

iii Phone

26323373

iv Email

pongnh@yahoo.com.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Bleach bath and S. aureus in childhood onset moderate-to-severe eczema

10 Public Title

Bleach bath and S. aureus in childhood onset moderate-to-severe eczema

i Public Title in Chinese 研究名稱

漂沐浴 (Bleach Bath) 對濕疹病童接受水平及金黃葡萄球菌的治療情況

11 Short Title (Optional)

Omit

12 Countries of Recruitment

Hong Kong, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-05-17

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

eczema

15 Intervention

i Types of intervention

Other

Please specify

Bleaching bathing

ii Description/ name of Intervention/article

Bleach bath (1:1200 dilution)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

1 month (active arm)

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo: water

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

eczema, ≤18 years and younger, moderate-to-severe disease

ii Exclusion Criteria

diagnosis uncertain; mild disease; intercurrent illness; recent oral antibiotic usage with 4 weeks

iii Age Minimum

> 1 year

iv Age Maximum

< 19 years

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Crossover

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2012-12-06

21 Target Sample Size

40

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

S. aureus status during the study period, monthly (absent, scanty, moderate, heavy growth)

24 Secondary Outcome

SCORAD, bacterial sensitivity, CDLQI, skin hydration, TEWL, acceptability of treatment, topical corticosteroid usage, +/- anti-SEA (if finance available)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-12-08

27 Primary Registry and Trial Identifying Number

ChiCTR-TTRCC-13002978

28 Date of Registration in Primary Registry

2013-01-06

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2013-04-26