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Trial record 35 of 1715 for:    psoriasis

Mechanistic Study of Indigo Naturalis in Treating Psoriasis

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ClinicalTrials.gov Identifier: NCT02088281
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : March 14, 2014
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: Indigo naturalis extract in oil ointment Phase 2

Detailed Description:

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:

  1. To investigate whether the effect of indigo naturalis in improving psoriatic symptoms is associated with the function of Th1/Th17 cells expressing IFN-γ and IL-17 in peripheral blood of patients with psoriasis before and after therapy.
  2. To investigate whether the effect of indigo naturalis in improving psoriatic symptoms is associated with the production of pro-inflammatory cytokines in peripheral blood of patients with psoriasis before and after therapy.
  3. To investigate whether the effect of indigo naturalis in improving psoriatic symptoms is associated with histopathological change in psoriatic lesions and whether these pathological changes are different from the change in inflammatory and immune reactions in patients with psoriasis.
  4. To investigate the effects of Th1/Th17-related cytokines and immunological factors in patients with indigo naturalis treatment on epidermal keratinocytes.
  5. To detect the effect of indigo naturalis on the function of releasing cytokines (IFN-γ, IL-17, and IL-23, etc.) from monocytes in patients with psoriasis.
  6. To analyze the concentration of indirubin in peripheral blood and to clarify whether the effect of indigo naturalis in improving psoriatic symptoms is: (A) a systemic effect that affects the metabolism and immune system through absorption and transdermal delivery into body. (B) a direct effect on the epidermal keratinocytes alone.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanistic Study of Indigo Naturalis in Treating Psoriasis: Local or Systemic Manipulation of Inflammation and Induction of Immunoregulation
Study Start Date : November 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Indigo naturalis extract in oil ointment
Indigo naturalis extract in oil ointment: each gram of ointment contains 200 μg±20 μg of indirubin.
Drug: Indigo naturalis extract in oil ointment
Apply 0.5 g of INEO ointment per 10 x 10 cm psoriasis lesion twice daily.
Other Name: INEO ointment




Primary Outcome Measures :
  1. The change of psoriasis severity compared to the change of Th1/ Th17 related cytokines from the peripheral blood [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. The relationship of the change in psoriasis severity and the associated change of the concentration of indirubin from the peripheral blood. [ Time Frame: 8 weeks ]
    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.

  2. The relationship of the change in psoriasis severity and the associated change in the Th1/ Th17 related cytokines from the target psoriatic lesion. [ Time Frame: 8 weeks ]
    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).


Other Outcome Measures:
  1. The change in the level of cytokines released from Th1/Th17 on epidermal keratinocytes after indigo naturalis treatment in vitro. [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 20 - 65 years, men or women
  • Diagnosed as plaque-type psoriasis by the dermatologist.
  • Plaque psoriasis involving <20% of the body surface area (BSA) and the psoriasis area and severity index (PASI) <20
  • If of child-bearing age, negative pregnancy test at screening, agreement to continue using birth control measures approved by the investigator for the duration of the study.
  • Willingness to comply with study protocol and signed informed consent form.

Exclusion Criteria:

  • A history of topically or systematically sensitivity to indigo naturalis or any component in excipient.
  • Systematic therapy for psoriasis within 4 weeks of baseline including Methotrexate (MTX), immunosuppressive agents (e.g. cyclosporine), retinoid (vitamin A derivatives), biologics (e.g. Etanercept, Alefacept, Infliximab), vitamin D3 analogs and phototherapy.
  • Topical therapy for psoriasis within 2 weeks of baseline including tar, corticosteroid, vitamin D3 analogs, retinoid.
  • Pustular or generalized erythrodermic psoriasis.
  • With abnormal liver or renal function (e.g. liver cirrhosis, hepatitis B/C, renal failure, creatinine >2.0 mg/dL, AST/ALT >3 x ULN), clinically significant abnormalities in hematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetes mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS.
  • Women who are lactating, are pregnant or are planning to become pregnant.

Information from the National Library of Medicine

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): NCT02088281


Locations
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Taiwan
Chang Gung Medical Foundation, Chang Gung University
Tao-Yuan, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
Investigators
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Principal Investigator: YIn-Ku Lin, MD., PhD. Department Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung

Additional Information:
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02088281     History of Changes
Other Study ID Numbers: NSC 101-2320-B-182-021-MY3
First Posted: March 14, 2014    Key Record Dates
Last Update Posted: March 14, 2014
Last Verified: October 2012
Keywords provided by Chang Gung Memorial Hospital:
Indigo naturalis, indirubin, Th1 cells, Th17 cells
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Indirubin
Antibiotics, Antineoplastic
Antineoplastic Agents