- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01735864
Dosage Determination Trial for Indigo Naturalis Extract in Oil Ointment
Evaluation of the Efficacy and Safety of Indigo Naturalis Extract in Oil in the Topical Therapy of Psoriasis Vulgaris: Dosage Determination
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The use of indigo naturalis ointment to treat psoriasis has been proven effective in our previous clinical studies which demonstrated the efficacy and safety of topical indigo naturalis ointment, showing its ability to provide significant improvement of psoriatic skin lesions.
We developed a new formulation in which indigo naturalis powder is refined and reduces the blue discoloration of skin and clothes, making the treatment more user-friendly. We had observed an equivalent efficacy of the refined form of indigo naturalis (INEO) ointment on treating psoriasis as the crude form. However, it is necessary to determine an appropriate dosage of the refined form regarding its efficacy and safety.
This is a double-blind, 4-arm parallel study. The aim of this study is
- To determine an appropriate dosage of indirubin in INEO ointment, regarding its efficacy and safety.
- To evaluate the efficacy of INEO ointment in different local skin signs of plaque lesions.
- To evaluate the efficacy of INEO in different traditional Chinese medicine clinical syndromes of psoriasis vulgaris.
- To investigate the effects of INEO ointment on the immune system.
- To evaluate the effects of INEO ointment in improving quality of life after treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Keelung, Taiwan
- Chang Gung Memorial Hospital at Keelung
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Taipei, Taiwan, 105
- Chang Gung Memorial Hospital at Taipei
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Taoyuan City, Taiwan
- Chang Gung Memorial Hospital at Linkou
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 20 - 65 years, men or women.
- Diagnosed as mild to moderate plaque-type psoriasis by the dermatologist, with psoriasis for a minimum of 1 year.
- Plaque psoriasis involving <20% of BSA and with PASI <20.
- Female patients of child-bearing age with negative pregnancy test at screening.
- Female patients of childbearing age who have agreed to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the study.
- Willingness to comply with study protocol.
- With signed informed consent form.
Exclusion Criteria:
- With history of topically or systematically hypersensitive to indigo naturalis or its excipient in ointment.
- With history of sensitivity to Chinese herb.
- Received systematic treatment for psoriasis within 4 weeks.
- Received topical treatment for psoriasis within 2 weeks.
- With abnormal liver or renal function, clinically significant abnormalities in hematology, severe uncontrolled metabolic syndrome,psychiatric disease, cancer or AIDS.
- Patients with pustular or erythrodermic psoriasis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Indirubin 200 μg/g
per gram of ointment contains 200 μg of indirubin
|
Other Names:
|
Active Comparator: Indirubin 100 μg/g
per gram of ointment contains 100 μg of indirubin
|
Other Names:
|
Active Comparator: Indirubin 50 μg/g
per gram of ointment contains 50 μg of indirubin
|
Other Names:
|
Active Comparator: Indirubin 10 μg/g
per gram of ointment contains 10 μg of indirubin
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the mean percentage change of Psoriasis Areas Severity Index (PASI) from baseline at week 8 between groups
Time Frame: 8 weeks
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body surface area (BSA)involved
Time Frame: 8 weeks
|
|
8 weeks
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Psoriasis Severity Index (PSI)
Time Frame: 8 weeks
|
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8 weeks
|
Efficacy in various local skin signs
Time Frame: 8 weeks
|
|
8 weeks
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Efficacy in different traditional Chinese medicine (TCM) clinical syndromes of psoriasis by PASI/PSI:
Time Frame: 8 weeks
|
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8 weeks
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Physician's Global Assessment (PGA)
Time Frame: 8 weeks
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0 = no sign of psoriasis, 1 = almost clear, 2 = mild, 3 = moderate, 4 = moderate to severe, and 5 = severe
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8 weeks
|
Subject's Global Assessment (SGA)
Time Frame: 8 weeks
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0 = cleared, 1 = excellent, 2 = good, 3 = fair, 4 = poor, and 5 = worse
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8 weeks
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Dermatology Life Quality Index (DLQI) questionnaire
Time Frame: 8 weeks
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8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yin-Ku Lin, MD., PhD., Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSC101-2325-B-182-018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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