A Study of Topical Indigo Naturalis Treatment in Patients With Mild to Moderate Plaque-type Psoriasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01901705|
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : February 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Drug: Indigo naturalis ointment Drug: Placebo||Phase 2|
Total of 24 subjects:
mild to moderate psoriasis patients will be randomized into treatment group (n=16) placebo group (n=8)
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 (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Study of Topical Indigo Naturalis Treatment in Patients With Mild to Moderate Plaque-type Psoriasis|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Active Comparator: Indigo
The Indigo naturalis ointment will be provided and patients are instructed to use it twice daily for 8 weeks or achieve completely skin clearing whichever comes first.
Drug: Indigo naturalis ointment
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)
Placebo Comparator: Placebo
The Placebo will be provided and patients are instructed to use it twice daily for 8 weeks or achieve completely skin clearing whichever comes first.
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.
- Change from baseline in Overall Target Plaque Severity Score at 8 weeks [ Time Frame: Baseline and at 8 weeks ]
OTPSS(Overall Target Plaque Severity Score ) Score Description 0 No evidence of disease (except possible residual discoloration)
- Mild overall plaque elevation, scaling and/or erythema of the target plaque
- Moderate overall plaque elevation, scaling and/or erythema of the target plaque
- Severe overall plaque elevation, scaling and/or erythema of the target plaque
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901705
|China Medical University Hospital,|
|Principal Investigator:||Hui man cheng||China Medical University Hospital|