Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00474

2 Trial Registration Date

2015-09-06

i Registration Status

Prospective

3 Secondary IDs

HMRF Ref: 11121011

4 Source(s) of Funding

Food and Health Bureau, Hong Kong

5 Primary Sponsor

School of Chinese Medicine, 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

LIN Zhi-Xiu

ii Address

School of Chinese Medicine
1/F, Sino Building
The Chinese University of Hong Kong
Shatin, N.T.

iii Phone

39436347

iv Email

linzx@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong, China

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

i Name

LIN Zhi-Xiu

ii Address

School of Chinese Medicine
1/F, Sino Building
The Chinese University of Hong Kong
Shatin, N.T.

iii Phone

39436347

iv Email

linzx@cuhk.edu.hk

v Affiliation

School of Chinese Medicine

vi Country

Hong Kong, China

9 Official Scientific Title of the Study

Clinical Assessment of a Topical Application Containing Radix Rubiae for Plaque-Type Psoriasis - A Randomized, Double-blind, Vehicle-Controlled and Left-Right Comparison Pilot Study

10 Public Title

A clinical trial of topical application containing Radix Rubiae for plaque-type psoriasis

i Public Title in Chinese 研究名稱

外用茜草製劑治療斑塊形銀屑病臨床試驗研究

11 Short Title (Optional)

A topical application containing Radix Rubiae for plaque-type psoriasis

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-05-14

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2011.544

14 Medical Condition Being Studied

Psoriasis

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

A topical application containing Radix Rubiae

iii Dosage form of the intervention

Gel dosage form

iv Dosage of the intervention

The amount of topical agent to be used by the patient is assessed by estimating the surface area involved of each psoriatic lesion.

v Duration of the intervention

12 weeks

vi Frequency of the intervention

twice a day

16 Comparative Treatments

i Description/ name of comparative treatments

A vehicle preparation on other side of the psoriatic lesion

ii Dosage form of the comparative treatments

Gel dosage form

iii Dosage of the comparative treatments

Same as the active one.

iv Duration of the comparative treatments

12 weeks

v Frequency of the comparative treatments

twice a day

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

(1) Men or women aged between 18 and 75 years old; (2) Mild to moderate, bilateral symmetric, chronic plaque psoriasis; and (3) In good general health, as evidenced by blood, liver and renal function tests conducted prior to the commencement of the study;

ii Exclusion Criteria

(1) Chronic plaque psoriasis involving >80% of the body surface; (2) Pustular or generalized erythrodermic psoriasis; (3) Systemic therapy for psoriasis within 30 d of baseline; (4) Use topical medications for psoriasis within 14 d of baseline such as retinoids, corticosteroids, vitamin D analogues, tazarotene and tacrolimus; (5) UV light therapy within 30 d of baseline; (6) Clinically significant laboratory abnormality in blood, liver or renal functions; (7) A history of sensitive to Chinese herbs or petroleum jelly; (8) Unwillingness to comply with study protocol; and (9) Any other condition that in the opinion of the investigators could compromise the study.

iii Age Minimum

18

iv Age Maximum

75

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

block randomization

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

2

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-10-01

21 Target Sample Size

60

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

PASI scores (area involved, erythema, induration and scaling scores)

ii The metric or method of measurement used

scale score

iii The timepoint(s) of primary interest

baseline and weeks 6 and 12

24 Secondary Outcome

i The Name of the outcome

Impact of Psoriasis Questionnaire (IPSO)

ii The metric or method of measurement used

scale score

iii The timepoint(s) of primary interest

baseline and weeks 12

Secondary Outcome

i The Name of the outcome

SF36

ii The metric or method of measurement used

scale score

iii The timepoint(s) of primary interest

baseline and weeks 12

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-05

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2015-09-06