NCT02088281

Mechanistic Study of Indigo Naturalis in Treating Psoriasis

Mechanistic Study of Indigo Naturalis in Treating Psoriasis: Local or Systemic Manipulation of Inflammation and Induction of Immunoregulation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	Indigo naturalis extract in oil ointment	Apply 0.5 g of INEO ointment per 10 x 10 cm psoriasis lesion twice daily.

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2014-03-14
• Last updated: 2014-03-14

Locations

1 site across 1 country: Taiwan