Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The potential effect of indigo naturalis on the immune system is unknown. The investigators hypothesize that the therapeutic effect of indigo naturalis in psoriasis may involve inhibiting the activation of Th1 and Th17 cells that produce pro-inflammatory cytokines, thereby regulating the hyperplasia of epidermis induced by Th1/Th17 related cytokines.
Psoriasis is a chronic inflammatory dermatosis induced by altered interactions between the immune system and skin and characterized by hyperplasia of the epidermis (acanthosis), infiltration of leukocytes into both the dermis and epidermis, and dilation and growth of blood vessels. Our previous studies have shown that topical application of indigo naturalis significantly improves psoriatic symptoms and demonstrated that the anti-psoriatic effects of indigo naturalis are mediated by promoting differentiation and inhibiting proliferation of epidermal keratinocytes. However, the potential effect of indigo naturalis on the immune system is unknown.
Currently, growing evidence demonstrates that activated T cells are the primary modulators in the pathogenesis of psoriasis and psoriasis is believed to be a mixed Th1/Th17 disease with strong IL-17 and interferon-γ (IFN-γ) signatures. The identification of elevated levels of IFN-γ, tumor necrosis factor (TNF-α), IL-12, IL-17 and IL 22 in cutaneous lesions and in the serum of psoriatic patients supports the theory that these Th1/Th17-related cytokines directly or indirectly act on keratinocytes leading to their activation and hyperproliferation. The investigators suppose the therapeutic effect of indigo naturalis in psoriasis may involve inhibiting the activation of Th1 and Th17 cells that produce pro-inflammatory cytokines, thereby regulating the hyperplasia of epidermis induced by Th1/Th17 related cytokines.
The aim of this study is:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indigo naturalis extract in oil ointment | Experimental | Indigo naturalis extract in oil ointment: each gram of ointment contains 200 μg±20 μg of indirubin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indigo naturalis extract in oil ointment | Drug | Apply 0.5 g of INEO ointment per 10 x 10 cm psoriasis lesion twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of psoriasis severity compared to the change of Th1/ Th17 related cytokines from the peripheral blood | The aim of this study is to clarify the mechanism of indigo naturalis in eliminating inflammation and in regulating the immune system by way of local or systemic effect. The investigators will evaluate the clinical efficacy which includes the mean percentage change of Psoriasis Areas Severity Index (PASI) and Body Surface Area (BSA) from baseline to week 8 as compared to the change in the Th1/ Th17 related cytokines in peripheral blood. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The relationship of the change in psoriasis severity and the associated change of the concentration of indirubin from the peripheral blood. | The aim of this study is to clarify the mechanism of indigo naturalis in eliminating inflammation and in regulating the immune system by way of local or systemic effect. The investigators will evaluate the clinical efficacy which includes the mean percentage change of Psoriasis Areas Severity Index (PASI) and Body Surface Area (BSA) from baseline to week 8 as compare to the concentration of indirubin in the peripheral blood. |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the level of cytokines released from Th1/Th17 on epidermal keratinocytes after indigo naturalis treatment in vitro. | The investigators will measure the effect of recombinant cytokines and cultured medium collected from peripheral blood mononuclear cells of patients pre- and post-treatment with indigo naturalis on cultured epidermal keratinocytes, and explore the effect of indigo naturalis on IFN-γ, IL-17 and IL-22 produced by activated mononuclear cells of patients with psoriasis. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| YIn-Ku Lin, MD., PhD. | Department Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Medical Foundation, Chang Gung University | Taoyuan | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 8 weeks |
| The relationship of the change in psoriasis severity and the associated change in the Th1/ Th17 related cytokines from the target psoriatic lesion. | The aim of this study is to clarify the mechanism of indigo naturalis in eliminating inflammation and in regulating the immune system by way of local or systemic effect. The investigators will evaluate the clinical efficacy which includes the mean percentage change of Psoriasis Areas Severity Index (PASI) and Body Surface Area (BSA) from baseline to week 8 as compared to the local immune response (the change of the histopathology from baseline to week 8). | 8 weeks |
| 8 weeks |