Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00579

2 Trial Registration Date

2018-01-17

i Registration Status

Prospective

3 Secondary IDs

N.A.

4 Source(s) of Funding

Direct Grant CUHK

5 Primary Sponsor

Hon KL, sponsored by Direct Grant CUHK

6 Secondary Sponsor

N.A.

Function

Not Applicable

Please specify

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

i Name

Esther Lam

ii Address

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

iii Phone

35052982

iv Email

esther-lam@cuhk.edu.hk

v Affiliation

Hospital Authority

vi Country

Hong Kong, China

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

i Name

Kam Lun HON

ii Address

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

iii Phone

35052856

iv Email

ehon@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong, China

9 Official Scientific Title of the Study

Effect of pine-tar shower on itch and diseae severity in moderate-to-severe childhood eczema

10 Public Title

Effect of pine-tar shower on childhood eczema

i Public Title in Chinese 研究名稱

松焦油沐浴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?

2017-08-24

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.399-T

14 Medical Condition Being Studied

Eczema

15 Intervention

i Types of intervention

Other

Please specify

Pine tar bath oil

ii Description/ name of Intervention/article

Product name: Pinetarsol
(pine tar bath oil 2.3% w/w)

iii Dosage form of the intervention

N.A.

iv Dosage of the intervention

10-20ml daily

v Duration of the intervention

4 weeks (active arm)

vi Frequency of the intervention

10-15 min. daily

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo: QV Baby Bath Oil

ii Dosage form of the comparative treatments

N.A.

iii Dosage of the comparative treatments

10-20ml daily

iv Duration of the comparative treatments

4 weeks

v Frequency of the comparative treatments

10-15 min. daily

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

- only patients with moderate-to-severe eczema of SCORAD (SCORing Atopic Dermatitis) scores >15 points will be recruited

ii Exclusion Criteria

- Subjects (patients and parents) have intercurrent illness for two weeks prior to study

- received any systemic antibiotics for at least 4 weeks prior

- subject with documented allergies to study product components

- subject enrolled in another clinical trial during the study period

- subject/parent considered by teh investigator to be likely not compliant to be likely not compliant to the protocol

iii Age Minimum

3

iv Age Maximum

18

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

through computerized randomization generated by a research staff not involved in the trial.

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Crossover

v Study Phase

Other

Please specify

N.A.

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-01-31

21 Target Sample Size

40

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

eczema severity

ii The metric or method of measurement used

by SCORAD (SCORing Atopic Dermatitis); modified POEM (Patient Oriented Eczema Measure)