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Trial History Detail on 2015-09-06

CUHK_CCRB00474

2015-09-06

Prospective

HMRF Ref: 11121011

Food and Health Bureau, Hong Kong

School of Chinese Medicine, CUHK

N/A

Not Applicable

LIN Zhi-Xiu

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

39436347

linzx@cuhk.edu.hk

CUHK

Hong Kong, China

LIN Zhi-Xiu

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

39436347

linzx@cuhk.edu.hk

School of Chinese Medicine

Hong Kong, China

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

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

外用茜草製劑治療斑塊形銀屑病臨床試驗研究

A topical application containing Radix Rubiae for plaque-type psoriasis

Hong Kong

Yes

2014-05-14

Joint CUHK-NTEC Clinical Research Ethics Committee

2011.544

Psoriasis

Drug

A topical application containing Radix Rubiae

Gel dosage form

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

12 weeks

twice a day

A vehicle preparation on other side of the psoriatic lesion

Gel dosage form

Same as the active one.

12 weeks

twice a day

(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;

(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.

18

75

Both Male and Female

Interventional

Randomized

block randomization

Placebo

Double-blind

Parallel

2

2015-10-01

60

Not Yet Recruiting

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

scale score

baseline and weeks 6 and 12

Impact of Psoriasis Questionnaire (IPSO)

scale score

baseline and weeks 12

SF36

scale score

baseline and weeks 12

No

2016-04-05

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