IRCT138904091159N7

Trial name or title	Comparison between the efficacy of intralesional placebo and nitric oxide releasing patch versus placebo patch and Glucantime in the treatment of cutaneous leishmaniasis
Methods	Randomised, placebo‐controlled trial
Participants	Inclusion criteria: diagnosis of acute zoonotic cutaneous leishmaniasis, proven parasitology by direct smear; aged 18‐50 years; lesion diameter ≤ 3 cm; 1 lesion, not located on the face near the eyes, joints, cartilage, on the nose and ears; < 3 months passed from diseases times Exclusion criteria: pregnancy and lactation; risk of presence or incidence of sporotrichoid or satellite lesions; history of hepatitis, heart, or kidney disorder; taking immunosuppressive medications (over the last 6 months); local or systemic treatment against leishmaniasis in the last 3 months; history of heart attack or high blood pressure; liver disease; anaemia; history of surgery for head and brain haemorrhage; taking blood pressure medications, antidepressants, or drugs used for angina
Interventions	Group 1: nitroglycerin patch (the pharmacy of Nour and Ali Asghar hospital in Isfahan) once a day covering 5.08 to 7.62 cm of lesion + intralesional injection of placebo (injection of distilled water) once a week (15‐30 mg) until whitening of base of the ulcer for 8 weeks or until complete cure Group 2: ILMA (Meglusan) from Avenue de Scheut company in Belium, once a week (15‐30 mg) until whitening of base of the ulcer + placebo patch (the pharmacy of Nour and Ali Asghar hospital in Isfahan) once a day covering 5.08 to 7.62 cm of lesion for 8 weeks or until complete cure
Outcomes	Improvement rate. Timepoint: 1, 2, 3, 4, 7, 8 weeks during treatment and 12, 16, 20 weeks after end of treatment. Method of measurement: observation and examination Induration. Timepoint: 1, 2, 3, 4, 7, 8, 12, 16, 20 weeks after end of treatment. Method of measurement: physical examination Lesion area. Timepoint: 8, 12, 20 weeks after end of treatment
Starting date	August 2013
Contact information	Fariba Jaffary Skin Diseases and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Sedigheh Tahereh (AS) Research Centers Complex, Khorram Ave., Isfahan, Iran Isfahan Iran, Islamic Republic Of Iran. 00983113373736 jaffary@pharm.mui.ac.ir
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