Psoriasis is a common, chronic skin disease for which only remissive, as opposed to curative, treatments are available. Traditional Chinese medicine is one of the most frequently chosen alternative therapies in China and Taiwan, and psoriasis has been treated for centuries with topical and oral herbal preparations. Topical indigo naturalis ointment has been reported to exhibit potential anti-psoriatic efficacy. The study objective is to investigate pharmacological effect and explore targeting mechanisms of Traditional Chinese Medicine (TCM) Indigo Naturalis topical ointment as a single treatment agent in Chinese subjects with mild to moderate plaque-type Psoriasis. This was a single site, randomized, double-blinded, placebo controlled study of topical indigo naturalis vs. vehicle alone (placebo) to treat mild to moderate plaque-type psoriasis during an 8-week period. Pharmacological effect will be evaluated by biomarker evaluation and clinical evaluation. The trial was conducted at the China Medical University Hospital (CMUH), Taichung, Taiwan. All patients provided written informed consent before inclusion in the study. The study protocol was approved by the institutional review board (IRB) of CMUH.
Estimated enrollment: Total of 24 subjects: mild to moderate psoriasis patients will be randomized into treatment group (n=16) placebo group (n=8) Study evaluation: A baseline and end of the study evaluation on the patients will be performed, including physical examination, hemogram and blood biochemical analysis (including glutamic-oxaloacetic transaminase, glutamic-pyruvic transaminase, and creatinine measurement). The baseline and end of the study of total body surface area involvement and Psoriasis Area Severity Index (PASI), PGA, OTPSS scores will be also calculated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
The Indigo naturalis ointment was composed of a 1:10 mixture of Indigo naturalis powder and a vehicle consisting of Vaseline: microcrystalline wax: olive oil (5:6:9 ratio)
The placebo was a mixture of blue dye powder (54.8% Indigo carmine aluminum lake \[Blue #32\] and 45.2% Allura Red AC aluminum lake \[Red #40\] powders), Vaseline, microcrystalline wax, and olive oil.
China Medical University Hospital,
Taichung, Taiwan
Change from baseline in Overall Target Plaque Severity Score at 8 weeks
OTPSS(Overall Target Plaque Severity Score ) Score Description 0 No evidence of disease (except possible residual discoloration) 1. \* 2. Mild overall plaque elevation, scaling and/or erythema of the target plaque 3. \* 4. Moderate overall plaque elevation, scaling and/or erythema of the target plaque 5. \* 6. Severe overall plaque elevation, scaling and/or erythema of the target plaque 7. \* 8. Very severe overall plaque elevation, scaling and/or erythema of the target plaque \*Grades 1, 3, 5 \& 7 are midpoints between the defined grades 0, 2, 4, 6 \& 8
Time frame: Baseline and at 8 weeks
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