Mechanistic Study of Indigo Naturalis in Treating Psoriasis

NCT02088281 | Completed Phase 2 DMC

• 1 other identifier: NSC 101-2320-B-182-021-MY3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Vulgaris

Keywords

Indigo naturalis, indirubin, Th1 cells, Th17 cells

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• The relationship of the change in psoriasis severity and the associated change of the concentration of indirubin from the peripheral blood.

  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.

  8 weeks

Other Outcomes (1)

• The change in the level of cytokines released from Th1/Th17 on epidermal keratinocytes after indigo naturalis treatment in vitro.

  8 weeks

Study Arms (1)

Indigo naturalis extract in oil ointment

EXPERIMENTAL

Indigo naturalis extract in oil ointment: each gram of ointment contains 200 μg±20 μg of indirubin.

Drug: Indigo naturalis extract in oil ointment

Interventions

Indigo naturalis extract in oil ointment DRUG

Apply 0.5 g of INEO ointment per 10 x 10 cm psoriasis lesion twice daily.

Also known as: INEO ointment

Indigo naturalis extract in oil ointment

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Chang Gung Medical Foundation, Chang Gung University

Taoyuan District, Taiwan

Location

Study Officials

• YIn-Ku Lin, MD., PhD.

  Department Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: March 14, 2014
• Study Start: November 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 14, 2014

Record last verified: 2012-10

Locations

TW (1)