Psoriasis Clinical Trial
Official title:
A Study of Topical Indigo Naturalis Treatment in Patients With Mild to Moderate Plaque-type Psoriasis
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.
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