Mechanistic Study of Indigo Naturalis in Treating Psoriasis

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Collaborator: National Science Council, Taiwan

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.