Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: a randomized assessor-blind controlled trial.
OBJECTIVE
To determine the efficacy and safety of imiquimod in combination with meglumine antimoniate in treating cutaneous leishmaniasis.


METHODS
Prospective, randomized, assessor-blind, parallel-design, placebo-controlled trial.


METHODS
Two primary care health clinics.


METHODS
One hundred nineteen patients (59 patients in the imiquimod group and 60 in the placebo group) were included in the study.


METHODS
Patients were randomly assigned to receive a combined 4-week course of imiquimod or placebo with meglumine antimoniate treatment (20 mg/kg of pentavalent antimony daily for 2 weeks) in an endemic area of Leishmania tropica.


METHODS
The primary end point was clinical cure, defined as more than 75% reduction in the size of lesions compared with baseline at week 8.


RESULTS
At the end of the 4-week treatment period, clinical cure was similar in both groups (11 patients [18.6%] in the imiquimod-treated group vs 18 patients [30.0%] in the placebo group) (P = .15). Four weeks after the end of treatment, 26 patients (44.1%) and 29 patients (48.3%) in the imiquimod-treated and placebo groups, respectively, were cured (P = .64). Pruritus and burning sensation were reported by 3 patients treated with imiquimod and by no patients treated with placebo.


CONCLUSIONS
This study showed no beneficial effect of combining a 4-week course of treatment with 5% imiquimod cream and a standard course of treatment with meglumine antimoniate in patients with cutaneous leishmaniasis in an endemic area of L tropica.


BACKGROUND
isrctn.org Identifier:ISRCTN77659407 and Cochrane Skin Group Identifier: CSG Trial No. 32.
Firooz
Alireza
A
Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Iran. firozali@sina.tums.ac.ir
Khamesipour
Ali
A
Ghoorchi
Mohammad H
MH
Nassiri-Kashani
Mansour
M
Eskandari
S Ebrahim
SE
Khatami
Alireza
A
Hooshmand
Badakhshan
B
Gorouhi
Farzam
F
Rashighi-Firoozabadi
Mehdi
M
Dowlati
Yahya
Y
D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000634:Aminoquinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D000818:Animals; D000965:Antimony; D000981:Antiprotozoal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077271:Imiquimod; D007895:Leishmania tropica / Q000302:isolation & purification; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy* / Q000469:parasitology / Q000473:pathology; D008297:Male; D008536:Meglumine / Q000008:administration & dosage / Q000627:therapeutic use*; D000077485:Meglumine Antimoniate; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D000981:Antiprotozoal Agents; D009942:Organometallic Compounds; D008536:Meglumine; D000077485:Meglumine Antimoniate; D000965:Antimony; D000077271:Imiquimod