Clinical assessment of patients with recalcitrant psoriasis in a randomized, observer-blind, vehicle-controlled trial using indigo naturalis.
OBJECTIVE
To evaluate the efficacy and safety of treatment with indigo naturalis in patients with recalcitrant plaque-type psoriasis.


METHODS
Randomized, observer-blind, vehicle-controlled, intrapatient comparison study.


METHODS
Ambulatory department of a hospital.


METHODS
Forty-two outpatients with chronic plaque psoriasis were enrolled in the study from May 1, 2004, to April 30, 2005.


METHODS
The patients applied either indigo naturalis ointment or vehicle ointment topically to each of 2 bilaterally symmetrical psoriatic plaque lesions for 12 weeks (depending on the date of enrollment in the study).


METHODS
The outcomes were assessed using the following criteria: the sum of erythema, scaling, and induration scores and the clearing percentage of the target plaque lesion assessed by 2 blinded observers.


RESULTS
Significant reductions in the sum of scaling, erythema, and induration scores (P < .001) (mean score, 6.3 after indigo naturalis treatment vs 12.8 in control subjects) and plaque area percentage (P < .001) (mean percentage, 38.5% after indigo naturalis treatment vs 90% in controls) were achieved with topical application of indigo naturalis ointment. Approximately 31 of 42 patients (74%) experienced clearance or near clearance of their psoriasis in the indigo ointment-treated lesion.


CONCLUSIONS
Topical indigo naturalis ointment was a novel, safe, and effective therapy for plaque-type psoriasis.
Lin
Yin-Ku
YK
Department of Traditional Chinese Medicine, Center for Traditional Chinese Medicine, Chang Gung Memorial Hospital, Taiwan.
Chang
Chee-Jen
CJ
Chang
Ya-Ching
YC
Wong
Wen-Rou
WR
Chang
Shu-Chen
SC
Pang
Jong-Hwei Su
JH
D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007203:Indigo Carmine; D029883:Indigofera; D007211:Indoles; D008297:Male; D008875:Middle Aged; D009824:Ointments / Q000627:therapeutic use; D008517:Phytotherapy / Q000379:methods*; D011336:Probability; D011565:Psoriasis / Q000175:diagnosis* / Q000188:drug therapy*; D012008:Recurrence; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013624:Taiwan; D016896:Treatment Outcome; D055815:Young Adult
D004365:Drugs, Chinese Herbal; D007211:Indoles; D009824:Ointments; D007203:Indigo Carmine