Randomised, observer-blinded, vehicle-controlled trial on the efficacy and safety of a topical indigo naturalis ointment treatment for recalcitrant psoriasis vulgaris

INTERVENTION: Forty patients with recalcitrant psoriasis vulgaris were treated with indigo naturalis ointment and ointment vehicles were applied daily to either of two bilaterally symmetrical plaques for 12 weeks. Every two weeks, the investigators evaluate the treated plaques. (As of 10/04/07 the following sentence should be disregarded: the patients and investigators were blinded as to the content of the two bottles). CONDITION: Recalcitrant chronic plaque psoriasis ; Skin and Connective Tissue Diseases ; Psoriasis PRIMARY OUTCOME: Clinical and laboratory assessments were done at baseline and every two weeks thereafter until 12 weeks after the start therapy. The changes in Erythema, Scaling, Indurations (ESI) and and bilateral plaque areas are recorded from the beginning to end of the treatments. Erythema (redness), scaling and indurations (thickening), are scored on a 0 to 8 scale (where 0 = none and 8 = very severe); the sum of these scores for each target lesion is the ESI score. The bilateral plaque area is rated from of 0% to 100% (0% = clearance and 100% = baseline). SECONDARY OUTCOME: Investigators will take biopsies from each treated lesion and analysis the immunohistochemical stains for markers of proliferation, differentiation and inflammation at the end of treatment. INCLUSION CRITERIA: 1. Participants with bilateral symmetric, chronic plaque‐type psoriasis 2. Participants who have a history of plaque psoriasis for a minimum of two years 3. Participants who have a history of resistance to at least two topical treatments (e.g. corticosteroid and vitamin D3 analogues) 4. Participants who have good general health and normal full blood picture, renal, and liver function in tests done before starting the study 5. Participants of childbearing age who agree to continue using birth control measures for the duration of the study 6. Males and females between 18 and 75 years