A double-blind study on the efficacy of oral dapsone in cutaneous leishmaniasis. Cutaneous leishmaniasis in India. Clinical experience with itraconazole (R51 211 Janssen). Treatment of cutaneous leishmaniasis with either topical paromomycin or intralesional meglumine antimoniate. Itraconazole and leishmaniasis: a randomised double-blind trial in cutaneous disease. Comparison of miltefosine and meglumine antimoniate for the treatment of zoonotic cutaneous leishmaniasis (ZCL) by a randomized clinical trial in Iran. A randomized, placebo-controlled trial in Tunisia treating cutaneous leishmaniasis with paromomycin ointment. Intralesional injection of 2% zinc sulfate solution in the treatment of acute old world cutaneous leishmaniasis: a randomized, double-blind, controlled clinical trial. Comparative study of the efficacy of oral ketoconazole with intra-lesional meglumine antimoniate (Glucantime) for the treatment of cutaneous leishmaniasis. Comparison between the efficacy of photodynamic therapy and topical paromomycin in the treatment of Old World cutaneous leishmaniasis: a placebo-controlled, randomized clinical trial. Weekly vs. fortnightly intralesional meglumine antimoniate in cutaneous leishmaniasis. Ketoconazole in the treatment of cutaneous leishmaniasis in Kuwait. Treatment of cutaneous leishmaniasis with aminosidine (paromomycin) ointment: double-blind, randomized trial in the Islamic Republic of Iran. A randomized trial comparing a pentavalent antimonial drug and recombinant interferon-gamma in the local treatment of cutaneous leishmaniasis. Comparison of intralesionally injected zinc sulfate with meglumine antimoniate in the treatment of acute cutaneous leishmaniasis. Efficacy of paromomycin ointment in the treatment of cutaneous leishmaniasis: results of a double-blind, randomized trial in Isfahan, Iran. A randomized, double-blind, clinical trial of topical clotrimazole versus miconazole for treatment of cutaneous leishmaniasis in the eastern province of Saudi Arabia. A randomized, double-blind, placebo-controlled clinical trial of itraconazole in the treatment of cutaneous leishmaniasis. Comparison of intralesional meglumine antimoniate, cryotherapy and their combination in the treatment of cutaneous leishmaniasis. Efficacy of local heat therapy by radiofrequency in the treatment of cutaneous leishmaniasis, compared with intralesional injection of meglumine antimoniate. Effect of combination therapy with systemic glucantime and pentoxifylline in the treatment of cutaneous leishmaniasis. Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: a randomized assessor-blind controlled trial. A randomized, placebo-controlled trial of a two-week regimen of aminosidine (paromomycin) ointment for treatment of cutaneous leishmaniasis in Iran. Comparison of topical paromomycin sulfate (twice/day) with intralesional meglumine antimoniate for the treatment of cutaneous leishmaniasis caused by L. major. A double-blind randomized clinical trial of a topical herbal extract (Z-HE) vs. systemic meglumine antimoniate for the treatment of cutaneous leishmaniasis in Iran. Effect of topical honey application along with intralesional injection of glucantime in the treatment of cutaneous leishmaniasis. Treatment of cutaneous leishmaniasis with itraconazole. Randomized double-blind study. Comparative study of the efficacy of combined cryotherapy and intralesional meglumine antimoniate (Glucantime) vs. cryotherapy and intralesional meglumine antimoniate (Glucantime) alone for the treatment of cutaneous leishmaniasis. Evaluation of CO laser efficacy in the treatment of cutaneous leishmaniasis. Local application of diminazene aceturate: an effective treatment for cutaneous leishmaniasis? Cutaneous leishmaniasis in Kuwait. Clinical experience with itraconazole. Efficacy of thermotherapy to treat cutaneous leishmaniasis caused by Leishmania tropica in Kabul, Afghanistan: a randomized, controlled trial. A double blind, randomised placebo controlled trial of rifampicin with omeprazole in the treatment of human cutaneous leishmaniasis. Evaluating the efficacy of allopurinol and meglumine antimoniate (Glucantime) in the treatment of cutaneous leishmaniasis. A comparative controlled trial of intralesionally-administered zinc sulphate, hypertonic sodium chloride and pentavalent antimony compound against acute cutaneous leishmaniasis. Fluconazole for the treatment of cutaneous leishmaniasis caused by Leishmania major. A randomized clinical trial of topical paromomycin versus oral ketoconazole for treating cutaneous leishmaniasis in Turkey. Treatment of cutaneous leishmaniasis with ketoconazole cream. Treatment of cutaneous leishmaniasis with a combination of allopurinol and low-dose meglumine antimoniate. Treatment of cutaneous leishmaniasis with antimony: intramuscular versus intralesional administration.
One hundred and twenty patients with localized cutaneous leishmaniasis were randomly allocated to receive tablets of dapsone (100 mg) or matching placebo tablets every 12 h for 6 weeks. No topical medication was used. Demonstration of Leishmania from skin lesions by the slit smear technique was mandatory for inclusion. Before, periodically during, and one month after completion of therapy an overall clinical assessment, haemoglobin determination, leucocyte count, and liver function tests were performed. 49 patients (82%) of those receiving dapsone were assessed as cured by clinical and parasitological criteria. Oral dapsone has certain advantages over other current forms of treatment: it is economical and widely available in countries where cutaneous leishmaniasis is common, and it is effective by mouth and well tolerated. Fifteen patients with cutaneous leishmaniasis were randomly selected for clinical trials with itraconazole. A single daily itraconazole dose of approximately 4 mg per 1 kg of body weight was administered to each patient with breakfast for 6 weeks. Five patients served as controls. On completion of therapy, ten cases in the study group (66.6%) were considered to be cured. No major adverse effects were reported. No significant changes were seen in the controls at the end of the study. The possibility of spontaneous recovery will be discussed in this report even though it is considered to be unlikely. Itraconazole has promising potential in cutaneous leishmaniasis therapy. Ninety-six patients with a clinical and parasitological diagnosis of cutaneous leishmaniasis were recruited to a comparative randomized clinical trial evaluating the efficacy of topical paromomycin vs. weekly intralesional injections of meglumine antimoniate. The patients were randomly divided into two treatment groups: one group was treated with topical paromomycin ointment and the other with intralesional meglumine antimoniate. Treatment was continued in both groups until complete recovery occurred (defined as healing in less than 2 months with no residual scar or relapse for up to 1 year post treatment). Treatment failure was defined as an increase in the number and size of pre-existing lesions or untoward side-effects. The maximum treatment period was 3 months. The patients were followed up for 1 year. The results showed that intralesional meglumine antimoniate led to 41.7% complete recovery, However, topical paromomycin gave a lower cure rate of 16.6% (P < 0.05). Treatment failure was observed in 39.7% of the group receiving intralesional meglumine and in 72.9% of those on topical paromomycin (P < 0.05). This study indicates that intralesional meglumine antimoniate is superior to topical paromomycin in the treatment of cutaneous leishmaniasis. Cutaneous leishmaniasis (CL) is a vector-borne parasitic disease of the skin. Previous open controlled studies with oral itraconazole suggest that it was effective for CL in India. Twenty patients with localised CL participated in this trial. Patients were allocated randomly to receive capsule itraconazole and matching placebo for 6 weeks. No topical medicines were used. Demonstration of Leishmania by slit smear was mandatory. Prior to, periodically during and 3 months after completion of therapy an overall clinical assessment, liver function tests and urinalysis were performed. On decoding, out of the 10 cases receiving drug itraconazole, 7 were declared cured by clinical and parasitological criteria. No major side-effects were noted. Spontaneous remission was observed in 1 case in the placebo group at 3 months follow up. Oral itraconazole has a promising antileishmanial thus secure CL patient from the hazards of antimonials. This study was a randomized, open label comparison that was designed to determine efficacy and safety of miltefosine as the first oral drug for the treatment of zoonotic cutaneous leishmaniasis caused by Leishmania major in comparison with meglumine antimoniate. Complete clinical response was defined as 100% re-epithelialization of the lesion. Definitions of lesion cure and failure were based on both clinical and parasitological criteria two weeks after the end of treatment and clinical recovery three months after this period. Of 32 patients enrolled for miltefosine treatment 28 patients completed treatment, of which 26 were cured at three months, corresponding to a cure rate of 92.9% on a per protocol analysis, and 81.3% according to intention to treat analysis. There was one failure (3.1%), one relapse (3.1%) and four dropouts due to lack of tolerability (12.5%) during the first week of treatment. Of 31 patients who received intramuscular meglumine antimoniate (20mgSb(5)/kg body weight daily for 14 days) 25 were cured (83.3% on a per protocol basis, 80.6% on intention to treat basis), five failed (16.1%) and one was lost (3.2%) at 3-month follow-up. At 6-month follow-up after the end of treatment, no relapse was observed. Both regimens were tolerated but averages of nausea (32.2%) and vomiting (21.5%) were observed in patients during two weeks after initiation of miltefosine treatment. Other gastrointestinal, musculoskeletal, and total adverse events were not statistically different in the two groups during one to four weeks after therapy initiation. No relevant changes were observed in levels of liver enzymes, creatinine and hematological tests before and after end of treatment in both groups. In conclusion, miltefosine is apparently at least as good as meglumine antimoniate for the treatment of cutaneous leishmaniasis caused by L. major in Iran, based on parasitological as well as clinical criteria two weeks, three months, and six months after end of treatment. A randomized, placebo-controlled, double-blind trial was carried out in 1992 in central Tunisia to assess the tolerability and efficacy of paromomycin ointment against zoonotic cutaneous leishmaniasis caused by Leishmania major. One hundred fifteen patients, 2--60 years of age, with a single lesion of parasitologically confirmed cutaneous leishmaniasis, were included in the trial. The ointment was applied twice a day from day 1 through day 14. Clinical and parasitologic evaluations of lesions were done at days 0, 15, 45, and 105. Fifty-seven patients were allocated the treatment and 58 the placebo. Based on local toxicity and laboratory evaluation, there was no difference in tolerability between the two groups. Parasitologic evaluation at day 15 showed that 74.5% of the treated group had negative smears compared with 56.4% among controls (P = 0.06). This difference was no longer apparent at days 45 and 105. Clinical evaluation at days 15, 45, and 105 did not indicate any difference between the two groups. The clinical evaluation at day 15 was a good predictor of the final prognosis of the lesion in the two groups when analyzed separately, suggesting no clinical relapse in either group. These findings suggest that paromomycin ointment should not be used in the present formulation as a treatment for zoonotic cutaneous leishmaniasis in Tunisia. Several in vitro and in vivo studies have shown inhibitory effects of zinc sulfate (ZnSO4) on Leishmania parasites. The objective of this study was to compare the efficacy of intralesional injections of 2% ZnSO4 solution with meglumine antimonate (Glucantime) in the treatment of acute Old World cutaneous leishmaniasis (CL). Seventy-two patients with CL lesions less than 8 weeks were recruited in a randomized, double-blind, clinical trial in an area endemic for Leishmania major after giving written informed consent. They were treated with 6 weekly intralesional injections of either drug. Among 36 patients with 53 lesions treated with ZnSO4 and 36 patients with 53 lesions treated with Glucantime, 13 patients with 19 lesions and 22 patients with 31 lesions completed the trial, respectively. Inadequacy of treatment was the main reason for drop-out in 12 (33.3%) and 2 (5.5%) patients in ZnSO4 and Glucantime groups, respectively (P < .05). Complete re-epithelialization was observed in 2 (10.5%) and 19 (61.3%) lesions 1 week after the end of treatment in the ZnSO4 and Glucantime groups, respectively (P < .05). In conclusion a 6-week course of weekly intralesional injections of 2% ZnSO4 solution was less effective than Glucantime in the treatment of acute Old World CL. Cutaneous leishmaniasis (CL) is a vector-borne parasitic disease caused by a range of Leishmania species. Many treatment modalities have been proposed, although pentavalent antimonials are still considered to be the first-line treatment of CL. However, due to the high cost and adverse effects of antimonials, as well as an increase in the number of resistant strains of CL to antimonials, this study was conducted to compare the efficacy of oral ketoconazole with intralesional meglumine antimoniate (Glucantime, Specia, Paris, France) for the treatment of CL.
                A total of 96 patients with CL were enrolled in the study. The diagnosis of CL was confirmed parasitologically using direct skin smears or skin biopsies. The patients were randomly allocated to two treatment groups. Group A (64 patients) was treated with ketoconazole 600 mg/day for adults and 10 mg/kg per day for children for 30 days. Group B (32 patients) was treated with 6-8 biweekly intra-lesional injections of meglumine antimoniate (Glucantime). Both groups were followed for 6 months after termination of treatment.
                The results showed complete clinical cure in 89% of cases in Group A (treated with oral ketoconazole) and 72% of cases in Group B (treated with intra-lesional Glucantime). This difference was statistically significant (p < 0.05). No significant side effects were observed in either treatment group.
                Oral ketoconazole can be an effective treatment modality in CL, especially in children afflicted with this disease. The optimal treatment for cutaneous leishmaniasis (CL) is not known. Topical paromomycin is one of the many drugs that have been suggested for the treatment of CL caused by Leishmania major. Recently, topical photodynamic therapy (PDT) has been reported to be effective in the treatment of CL.
                To compare the parasitological and clinical efficacy of PDT vs. topical paromomycin in patients with Old World CL caused by L. major in Iran.
                In this trial, 60 patients with the clinical and parasitological diagnosis of CL were recruited and were randomly divided into three treatment groups of 20 subjects each. Group 1 was treated with weekly topical PDT, and groups 2 and 3 received twice-daily topical paromomycin and placebo, respectively. The duration of treatment was 4 weeks for all groups. These groups were followed for 2 months after the end of treatment.
                In total, 57 patients with 95 lesions completed the study. At the end of the study, complete improvement was seen in 29 of 31 (93.5%), 14 of 34 (41.2%) and 4 of 30 lesions (13.3%) in groups 1, 2 and 3, respectively (P<0.001). At the same time point, 100%, 64.7% and 20% of the lesions had parasitological cure in group 1, 2 and 3, respectively (P<0.001).
                Topical PDT can be used safely as a rapid and highly effective alternative treatment choice for Old World CL in selected patients. nan nan To compare the parasitological and clinical efficacy of four weeks versus two weeks of treatment with aminosidine (paromomycin) ointment in patients with cutaneous leishmaniasis caused by Leishmania major in the Islamic Republic of Iran.
                Double-blind, randomized trial of four weeks of aminosidine ointment (n = 108) vs two weeks of aminosidine ointment and two weeks of placebo (n = 108). Patients were assessed on days 15, 29, 45, and 105 for clinical cures and clinical and parasitological cures.
                Four weeks' treatment gave significantly better cure rates than two weeks' treatment: on day 29, there were 80/108 (74%) vs 64/108 (59%) clinical cures (P = 0.05) and 47 (44%) vs 26 (24%) clinical and parasitological cures (P = 0.005). By day 45, fewer patients who received four weeks' treatment had required rescue treatment with antimonials than those who received two weeks' treatment: 20 (19%) vs 36 (33%) (P = 0.02). On day 105, the results still favoured those who had been allocated four weeks of active treatment, but the differences were no longer as clearly significant. No side-effects were observed or reported.
                Approximately two-thirds of patients given ointment for four weeks were cured clinically. Although about half of those cured might have recovered spontaneously even without treatment, four weeks of aminosidine ointment could become the first-line treatment for uncomplicated cutaneous leishmaniasis due to L. major, with antimonials needed in only the one-third of patients not cured by the end of treatment with aminosidine. This would considerably reduce the costs and side-effects associated with antimonial drugs. In a randomized prospective trial N-methyl-glucamine antimoniate (Glucantime) and human recombinant interferon-gamma were infiltrated around lesions of cutaneous leishmaniasis caused by Leishmania tropica in Syria. A previous trial had shown that intradermal application of interferon-gamma promoted the healing of similar lesions in the study area. Twenty patients with 38 lesions received 1-3 ml Glucantime and 20 patients with 37 lesions received 25 micrograms of interferon-gamma intradermally once weekly for 5 consecutive weeks. While all lesions treated with Glucantime were free of parasites after the third injection, only 69% of those treated with interferon-gamma were parasitologically cured by week 10. Within 10 weeks, lesions treated with Glucantime healed completely in 29/38, and partially in 9/38, cases, whereas 1/37 and 13/37 lesions treated with interferon-gamma healed completely and partially, respectively. Perilesional application of Glucantime was highly effective and superior to interferon-gamma for treatment of cutaneous leishmaniasis caused by L. tropica. Cutaneous leishmaniasis is an endemic disease in developing countries. The first-line drugs for its treatment are the pentavalent antimony compounds such as meglumine antimoniate (MA). High cost, side effects, multiple injections and incomplete efficacy are limitations of this therapy. Zinc sulfate (ZS) has been reported to be effective in the treatment of cutaneous leishmaniasis.
                To compare the efficacy of intralesional injections of ZS 2% with those of MA in the treatment of cutaneous leishmaniasis.
                This was a prospective, double-blind, case-control clinical study. 104 patients with typical lesions of acute cutaneous leishmaniasis (ACL) were included. The duration of treatment was 6 weeks. Improvement was evaluated by clinical examination and direct smear.
                The study was completed in only 66 patients: 35 patients received MA and 31 received ZS. The cure rates were 60% for MA and 83.8% for ZS. After the second and fourth weeks, the efficacy of treatment with ZS was higher than that with MA (p < 0.01), but after 6 weeks no significant differences were observed between the two groups (p > 0.05).
                On the basis of this trial and despite the high number of drop-outs, we consider that the intralesional injection of ZS 2% is an alternative treatment in ACL.
                Copyright 2004 S. Karger AG, Basel Although pentavalent antimonials are often used in the first-line treatment of cutaneous leishmaniasis (CL), they have several adverse effects. Intralesional administration of antimonials and other antileishmanial drugs can be painful. In the present, double-blind, randomized study, to determine if topical treatment with paromomycin is effective in the treatment of CL, 35 cases of CL were treated, twice daily for 30 days, with a commercial skin-care lotion containing 10% urea (the placebo) and another 30 were similarly treated with the same lotion to which paromomycin sulphate had been added (to give a concentration of 15%). Each case was assessed clinically 7, 14, 21 and 30 days after treatment began, and parasitologically 30 and 60 days after the initiation of treatment. Five (17%) and five (17%) of the cases treated with paromomycin showed complete healing, with the apparent clearance of amastigotes from their lesions, 30 and 60 days after treatment began, respectively. At the same time-points, however, the lesions on six (17%) and seven (20%) of the cases in the placebo group, respectively, also appeared to have healed completely. Ointment containing 15% paromomycin therefore appears ineffective in the treatment of CL, at least when applied twice daily for 30 days to the lesions of cases from an endemic area of Isfahan, Iran. The parenteral treatment currently available for cutaneous leishmaniasis (CL) is painful and potentially exposes patients to serious side effects. Thus, effective, topical therapy would be valuable. We assessed the efficacy of topical 1% clotrimazole and 2% miconazole creams in relation to early healing of lesions in CL in a randomized, double-blind clinical trial in 54 patients with 151 lesions treated for 30 consecutive days. Response to treatment was assessed at two weeks and 30 days and classified as fully healed, size reduced, no change, and size increased or worse. Of 89 lesions treated with clotrimazole, 14 (15.7%) healed fully, 42 (47.2%) were reduced in size, 20 (22.5%) showed no change, and 13 (14.6%) got worse. Correspondingly, in the 62 lesions treated with miconazole, none healed fully, 22 (35.5%) were reduced in size, 16 (25.8%) showed no change, and 24 (38.7%) got worse. The differences were statistically significant (P < 0.001). No side effects were observed. It is concluded that clotrimazole was the more effective of the two imidazoline compounds and is recommended as initial treatment for simple lesions. Several modalities have been used for the treatment of cutaneous leishmaniasis (CL) with various results. In vitro and in vivo studies have shown inhibitory effects of azole drugs on Leishmania parasites.
                To evaluate the efficacy and tolerability of oral itraconazole in the treatment of CL caused by L. major.
                A total of 200 patients with parasitologically confirmed CL with a duration of less than 45 days from a well known L. major endemic area were included in a randomized, double-blind, placebo-controlled clinical trial. The patients received either itraconazole 200 mg daily (100 patients) or placebo (100 patients) for 8 weeks. The primary outcome measures were clinical cure (complete re-epithelization of all lesions) and parasitological cure at the end of the treatment.
                Eighty-three patients in the itraconazole and 75 patients in the placebo group completed the treatment course. After 8 weeks of treatment, clinical cure was observed in 59% and 53% and parasitological cure was observed in 83% and 76% of patients in the itraconazole and placebo groups, respectively, which were not significantly different. There was no difference in the rate of adverse events.
                An 8-week course of oral itraconazole was not more effective than placebo in the treatment of CL. nan Cutaneous leishmaniasis (CL) is a serious public health problem in many tropical and subtropical regions of the world. Treatment of CL can prevent disfiguring scars.
                The efficacy of local heat therapy by radiofrequency (RF) was compared with intralesional injection of meglumine antimoniate in the treatment of CL.
                This was a randomized clinical trial. Patients with antroponotic cutaneous leishmaniasis (ACL) in the Isfahan province of Iran were enrolled in the study if the examination of a smear from a suspected CL lesion was confirmed positive for Leishmania. Patients were randomly allocated to one of two treatment groups. Group A was treated by heat therapy by RF at 50 degrees C for 30 s once weekly for 4 weeks, and group B was treated with intralesional injection of meglumine antimoniate once weekly for 4 weeks. Follow-up lasted 6 months. Response to treatment was classified as complete (lesions flattened, no induration, and epidermal creases had appeared), partial (reduction in lesion size, but without the appearance of epidermal creases) and poor (no reduction in lesion size).
                Of 117 participants, 57 patients with 83 lesions in group A and 60 patients with 94 lesions in group B completed the study and were followed up for 6 months. Complete, partial and poor response to treatment were 80.7%, 12% and 7.3% in group A, and 55.3%, 21.27% and 23.40% in group B, respectively (P = 0.001). In both groups, there was no relapse in patients with complete response after 6 months of follow-up.
                Heat therapy with thermogenerator RF can be used as an efficacious treatment in the lesions of CL. It is more effective than the conventional treatment with intralesional meglumine antimoniate injection. Cutaneous leishmaniasis is a common parasitic disease in Iran, especially in Isfahan. First line treatment for this disease is antimonial compounds; however, owing to the intermittent failure of this treatment and its significant side-effects alternative therapeutic measures have been advocated.
                Evaluating the efficacy of pentoxifylline plus glucantime in the treatment of cutaneous leishmaniasis.
                This double-blind, randomized, controlled clinical trial with simple sampling was performed on 64 patients with cutaneous leishmaniasis referred to the Skin Diseases & Leishmaniasis Research Center from an endemic foci of L. major in Isfahan. The patients randomly were divided into two groups. One group was treated with systemic Glucantime (20 mg pentavalent antimony/kg/day) combined with pentoxifylline (400 mg three times daily) and the other group were treated with Glucantime (20 mg pentavalent antimony/kg/day) plus placebo (three tablets daily) for 20 days. Follow up lasted 3 months. Response to treatment was grouped as complete improvement (lesions had been flattened, no induration, and epidermal creases had appeared), partial improvement (reduction in lesion size, but without the appearance of epidermal creases) and poor response (no reduction in lesion size).
                Of 64 participants, 32 patients in the trial group and 31 patients in the control group were followed for 3 months. One patient in group B discontinued withdrew. After this time, complete improvement, partial improvement and poor response to treatment were 81.3%, 12.5% and 6.2% in the trial group and 51.6%, 29% and 19.4% in the control group, respectively. We also observed no adverse effect resulting from pentoxifylline.
                The result obtained by two therapeutic methods indicates that combined therapy with Glucantime and pentoxifylline is more effective than Glucantime alone (P < 0.05). To determine the efficacy and safety of imiquimod in combination with meglumine antimoniate in treating cutaneous leishmaniasis.
                Prospective, randomized, assessor-blind, parallel-design, placebo-controlled trial.
                Two primary care health clinics.
                One hundred nineteen patients (59 patients in the imiquimod group and 60 in the placebo group) were included in the study.
                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.
                The primary end point was clinical cure, defined as more than 75% reduction in the size of lesions compared with baseline at week 8.
                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.
                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.
                isrctn.org Identifier:ISRCTN77659407 and Cochrane Skin Group Identifier: CSG Trial No. 32. The effect of a two-week regimen of topical aminosidine was investigated in a randomized, double-blind, placebo-controlled trial of 251 selected Iranian patients with zoonotic cutaneous leishmaniasis. Patients underwent clinical and parasitologic assessment before and 15 (end of therapy), 45, and 105 days after starting the treatment. Aminosidine ointment was safe and well-tolerated, and produced significant reductions in the prevalence of parasitologically positive smears on days 15 and 105 (but not day 45) after treatment compared with placebo. However, there was no clear clinical benefit at any stage after treatment. We conclude that this twice a day two-week regimen of aminosidine was inadequate to accelerate the recovery of most cases of cutaneous leishmaniasis. However, the ointment did show some clear evidence of parasitologic efficacy and should now be studied in longer or more frequent regimens in an effort to prevent parasitologic relapse and thus promote clinical improvement. This is an open study to compare the cure rate of cutaneous leishmaniasis caused by L. major and treated with either paromomycin sulfate or intralesional injection of meglumine antimoniate. Sixty parasitologically proven cases with 1-3 lesions were included and divided randomly into two equal groups; one group received 1 ml of meglumine antimonate intradermally every other day for 20 days, the other group received the ointment containing 15% parmomycin sulfate in urea twice daily for 20 days. The patients were clinically evaluated at 1 and 6 weeks after treatment was completed. The results of clinical evaluation at 1 week after treatment completed showed a cure rate of 18 out of 27 (66%) in the meglumine antimonate injected group and 20 out of 29 (68%) in the paromomycin sulfate treated group. The chi square test was used to compare the cure rate between the two groups and showed no significant difference (p = 0.85). nan Leishmaniasis is an endemic disease in Iran. Although many treatments have been suggested for this disease, there hasn't been an effective and safe treatment yet. Regarding the healing effect of honey in the chronic ulcers and its reported therapeutic effect in cutaneous leishmaniasis, we performed a study to better evaluate the efficacy of honey in cutaneous leishmaniasis and its final scar.
                In a prospective clinical trial, 100 patients with confirmed cutaneous leishmaniasis were selected and randomized into 2 groups. Group A were treated with topical honey twice daily along with intralesional injection of glucantime once weekly until complete healing of the ulcer or for maximum of 6 weeks. Group B were treated with intralesional injection of glucantime alone until complete healing of the ulcer or for a maximum of 6 weeks, too. The patients were followed for 4 months. The collected data were analyzed statistically using statistical tests including Chi-square, Mann Whitney and Kaplan-Mayer tests.
                In this study, 45 patients that had cutaneous leishmaniasis were treated with intralesional glucantime alone and 45 patients were treated with topical honey and glucantime. Ten patients left out the study. In the glucantime alone treated group, 32 patients (71.1%) had complete cure whereas in the group treated with both glucantime & topical honey, 23 patients (51.1%) achieved complete cure. This difference was significant statistically (p = 0.04).
                Further studies to better clarify the efficacy of honey in cutaneous leishmaniasis is needed. We suggest that in another study, the efficacy of honey with standardized level of antibacterial activity is evaluated against cutaneous leishmaniasis. To compare the efficacy of itraconazole with placebo in the treatment of cutaneous leishmaniasis caused by Leishmania major.
                Double-blind placebo-controlled study.
                Patients were selected from volunteers wit cutaneous leishmaniasis who lived in a hyperendemic area.
                One hundred forty patients were randomly selected for this double-blind study. Exclusion criteria were pregnancy, gestation, age younger than 12 years, and duration of disease of more than 4 months.
                Each patient received itraconazole (7 mg/kg per day) or placebo for a 3-week period. The patients were kept under observation for an additional 30-day period. OUTCOME. The study was completed as planned in 131 patients.
                Complete healing occurred in 59% of the itraconazole group in comparison with 44.3% of the patients who were treated with placebo capsules. No difference was found between the 2 groups with respect to adverse effects.
                Although itraconazole has the advantage of being an oral agent that is used in the treatment of cutaneous leishmaniasis, the low response rate in patients receiving itraconazole indicates that itraconazole cannot be used as the single agent in the treatment of patients with cutaneous leishmaniasis caused by L. major. Cutaneous leishmaniasis (CL) is a parasitic disease caused by Leishmania species. There is a need for more effective and less time-consuming therapeutic methods for this condition.
                To evaluate the efficacy of combined cryotherapy and intralesional meglumine antimoniate (MA) (Glucantime, Specia, Paris, France) for the treatment of CL.
                Patients were divided into three groups: Group 1, 100 patients with 149 lesions were treated with cryotherapy plus intralesional MA; Group 2, 200 patients with 230 lesions were treated with cryotherapy; Group 3, 100 patients with 160 lesions were treated with intralesional MA. These groups were followed for 6 months after the end of treatment.
                The results showed complete cure in 90.9% of cases in Group 1, 57.15% of cases in Group 2, and 55.63% of cases in Group 3. The difference between Group 1 and the other groups was statistically significant (P < 0.05).
                Combined cryotherapy and intralesional MA is more effective than either cryotherapy or intralesional MA alone for the treatment of CL. Cutaneous leishmaniasis is a common disease in Iran, especially in the north-east, central and southern parts of the country. Many treatments have been suggested for this disease but none is completely effective and without side-effects such as pain, arthralgia and renal or cardiac complications. Lasers have been used for treatment of several skin diseases since 1970, and CO(2) lasers are now being used for treatment of leishmaniasis. In this study, a CO(2) laser (Sonic 500 machine) was used as a source of a continuous CO(2) laser wave.
                A total of 123 patients (68 female and 55 male) with 183 lesions were treated with the CO(2) laser. The maximum power was 100 W and the pulse width was 0.5-5 s. For the control group, 110 patients (with 250 lesions) were treated with glucantime 50 mg/kg/day for 15 days and, after 15 days of rest, this treatment was repeated (Glucantime Amps, 1.5 g in a 50-mL solution, was used). For follow-up, the patients were visited 1, 3, 4, 8, 12 and 24 weeks after treatment and any complications, recurrences or other wound characteristics were recorded. In the second group, Finally, all collected data were analyzed statistically.
                Statistical analysis with the chi(2) test showed that treatment with the CO(2) laser was more effective than treatment with glucantime (P = 0.0007). Complications were also seen less often with the laser treatment than with glucantime and were limited to the ulcer site. The CO(2) laser was more effective in treating cutaneous leishmaniasis than glucantime (1.12 times), had fewer side-effects (4.5% vs. 24%) and resulted in a shorter healing time (1 month vs. 3 months), and treatment could be applied in a single session.
                The results of this and previous studies suggest that cutaneous leishmaniasis can be treated effectively with CO(2) laser if those providing the treatment are sufficiently experienced. Laser treatment is more cost-effective than other treatments and can be used as first-line therapy for cutaneous leishmaniasis (wet and dry types). In a controlled clinical trial we tested the effect of diminazene aceturate (Berenyl, Bayer) in local application against cutaneous leishmaniasis. The study was performed among schoolchildren in Nyala, West-Sudan in 1988 during a major outbreak of cutaneous leishmaniasis in this region. Sixty-six schoolchildren with cutaneous leishmaniasis were enrolled in the study. The children were randomly assigned to either diminazene aceturate (Berenil) or cetrimide 15% + chlorhexidine 1.5% (Savlon) treatment. The study results show a significant faster healing of the ulcers in the children treated with diminazene aceturate (chi-square 7.31, p less than 0.01). We conclude that diminazene aceturate should be considered as a potential topical drug in the treatment of cutaneous leishmaniasis. Twenty-four patients suffering from single or multiple lesions of cutaneous leishmaniasis were included in this study. Most of the lesions were on the extremities. The patients were randomly divided into two groups. Most of the patients in the first group who were given oral itraconazole for a period of 6-8 weeks showed excellent clinical response. On the other hand, only one patient in the second control group who was given placebo showed good clinical improvement. Systemically administered itraconazole may prove to be a valuable modality for the treatment of cutaneous leishmaniasis. Pentavalent antimony is the agent recommended for treatment of cutaneous leishmaniasis (CL). Its use is problematic, because it is expensive and because of the potential for drug-associated adverse effects during a lengthy and painful treatment course.
                We tested the efficacy of thermotherapy for the treatment of CL due to Leishmania tropica in a randomized, controlled trial in Kabul, Afghanistan. We enrolled 401 patients with a single CL lesion and administered thermotherapy using radio-frequency waves (1 treatment of >or=1 consecutive application at 50 degrees C for 30 s) or sodium stibogluconate (SSG), administered either intralesionally (a total of 5 injections of 2-5 mL every 5-7 days, depending on lesion size) or intramuscularly (20 mg/kg daily for 21 days).
                Cure, defined as complete reepithelialization at 100 days after treatment initiation, was observed in 75 (69.4%) of 108 patients who received thermotherapy, 70 (75.3%) of 93 patients who received intralesional SSG, and 26 (44.8%) of 58 patients who received intramuscular SSG. The OR for cure with thermotherapy was 2.80 (95% confidence interval [CI], 1.45-5.41), compared with intramuscular SSG treatment (P=.002). No statistically significant difference was observed in the odds of cure in comparison of intralesional SSG and thermotherapy treatments. The OR for cure with intralesional SSG treatment was 3.75 (95% CI, 1.86-7.54), compared with intramuscular SSG treatment (P<.001). The time to cure was significantly shorter in the thermotherapy group (median, 53 days) than in the intralesional SSG or intramuscularly SSG group (median, 75 days and >100 days, respectively; P=.003).
                Thermotherapy is an effective, comparatively well-tolerated, and rapid treatment for CL, and it should be considered as an alternative to antimony treatment. This study was conducted on 50 patients of Anthroponotic cutaneous leishmaniasis (oriental sore) to assess the efficacy of rifampicin and omeprazole through a double blind, randomised placebo control study.
                The diagnosis of Anthroponotic cutaneous leishmaniasis (ACL) caused by Leishmania tropica was done by demonstration of Leishmania tropica (LT) bodies from the painless, dry ulcerative lesion. Each patient was assessed clinically in the beginning of the study, at the end of 2,4 and 6 weeks and all observations were compared in both the groups. Twenty-five patients received rifampicin with omeprazole (Group A) whereas other 25 patients received placebo (Group B) for a period of six weeks.
                Altogether 23 cases in group Aand 21 cases in group B completed the study. About 16 (69.7%) cases in group A and 3 (14.29%) cases in group B had complete healing, whereas 3 patients (13.04%) of group A and 4 patients (19.05%) of group B had partial response and 4 patients (17.93%) of group A and 14 patients (66.67%) of group B had no response at the end of study. The difference of two groups was statistically highly significant (p < 0.00025). All patients tolerated the drug and placebo very well and no side effect was reported.
                In our opinion rifampicin and omeprazole is a highly effective, less toxic and cheaper alternative for the management of cutaneous leishmaniasis. Cutaneous leishmaniasis is a common disease in Iran, particularly in Kerman province. It usually occurs via the bite of an infected sandfly.
                One hundred and fifty patients suffering from cutaneous leishmaniasis were included in this study in Kerman. The patients were randomly divided into three groups. They were matched with regard to age, sex, duration of the disease, and type, number, and site of the lesions. For each group, one of the following therapeutic methods was applied: (i) oral allopurinol (15 mg/kg/day) for 3 weeks; (ii) intramuscular injection of Glucantime (30 mg/kg/day), corresponding to 8 mg/kg/day of pentavalent antimony, for 2 weeks; (iii) combined therapy. The lesions were re-examined at the end of treatment and 2 and 4 weeks later. The response to treatment was graded as excellent (reduction in the size of the lesion by at least 80% or complete clearance), good (reduction in the size of the lesion by 50%), and poor (minimal or no change in the lesion).
                The overall results indicated that 18% of patients showed excellent response, 6% good response, and 76% poor response in the first group. In the second group, 24% of patients showed excellent response, 6% good response, and 70% poor response. In the third group, 46% of patients showed excellent response, 8% good response, and 46% poor response.
                The results obtained by the three therapeutic methods indicated that combined therapy with allopurinol plus Glucantime was much more effective than that obtained by each of the two drugs when used alone (P < 0.05). A comparative clinical trial between two newly introduced intralesional treatments for acute leishmaniasis and the established treatment of intralesionally-administered pentavalent antimony compounds was performed. Treatments were allocated randomly to a total of 63 patients who received 2% zinc sulphate, 7% sodium chloride solutions or sodium stibogluconate intralesionally. A number of patients were left without treatment as controls. Patients were followed-up for 45 days, the results showing that the three treatments gave comparable cure rates by the end of the follow-up period. However, zinc sulphate gave a high cure rate (94.8%) usually with a single injection. Whereas certain oral antifungal azoles are well documented to have activity against leishmania, data on the efficacy of fluconazole for leishmaniasis are limited. We conducted a controlled trial in Saudi Arabia of fluconazole for the treatment of cutaneous leishmaniasis caused by Leishmania major.
                This randomized, double-blind, placebo-controlled trial assessed the efficacy of oral fluconazole, in a dose of 200 mg daily for six weeks, in the treatment of parasitologically confirmed cutaneous leishmaniasis. The primary outcome measure was the time to the complete healing of all lesions.
                A total of 106 patients were assigned to receive fluconazole, and 103 patients were assigned to receive placebo. Follow-up data were available for 80 and 65 patients, respectively. At the three-month follow-up, healing of lesions was complete for 63 of the 80 patients in the fluconazole group (79 percent) and 22 of the 65 patients in the placebo group (34 percent; relative risk of complete healing, 2.33 [95 percent confidence interval, 1.63 to 3.33]). According to an intention-to-treat analysis, the rates of healing were 59 percent and 22 percent, respectively (relative risk, 2.76 [95 percent confidence interval, 1.84 to 4.12]). Sodium stibogluconate was offered to 11 patients in the fluconazole group who returned for follow-up (14 percent) and 33 of those in the placebo group (51 percent) in whom oral treatment was judged to have failed. According to a Kaplan-Meier analysis, the time to healing was shorter for the fluconazole group (median, 8.5 weeks, as compared with 11.2 weeks in the placebo group; P<0.001 by the log-rank test). Side effects were mild and similar in both groups.
                A six-week course of oral fluconazole is a safe and useful treatment for cutaneous leishmaniasis caused by L. major. An open-labeled, randomized clinical trial to evaluate the efficacy of paromomycin ointment as compared with ketoconazole was conducted on seventy-two patients of both sexes and different ages with the confirmed diagnosis of cutaneous leishmaniasis (CL). All patients had a complete clinical evaluation for other diseases. Patients were excluded if they were pregnant or nursing or if they had serious concomitant diseases. Patients were divided randomly into two treatment groups: in the first group 40 patients were treated with an ointment containing 15% paromomycin sulfate and 12% methylbenzothonium chloride in white soft paraffin (labeled as p-ointment by El-On1) twice daily for 15 days. Treated lesions were left uncovered. The second group consisted of 32 patients who received ketoconazole 400 mg/day orally for 30 days. This dosage was reduced to 200 mg/day for patients below 12 years of age. In all cases the diagnosis was based on positive smear and/or culture. Direct smears were prepared from the exudate obtained by a small incision made at the edge of the lesion with a sterile surgical blade or lancet and stained using the Giemsa method for leishmania bodies (Fig 1). In smear negative and suspected cases aspirates taken by puncturing the lesions were inoculated onto NNN (Novy, McNeal, Nicolle) medium for culture. The cultures were incubated at 28 degrees C and the development of motile promastigotes was observed. Clinical and parasitological evaluations of the patients were performed at the end of the treatment period and 4 weeks post-treatment. A cure was defined as complete healing and disappearance of the lesion or reversible hypopigmentation at the site of lesion. Incomplete or partial improvement was defined as a reduction in the size of a lesion and the absence of parasites on smear or culture. A treatment failure was defined as the absence of any changes in the lesion and persistence of parasites on smear or culture. Cutaneous leishmaniasis (CL) is endemic in many countries. It has been recognized as a major public health problem in Iran. Many drugs have been suggested for the treatment of CL but most of them used intramuscularly or intravenously. Recently, a ketoconazole tablet has been used for the treatment of CL.
                To compare the efficacy of ketoconazole cream with placebo in the treatment of CL.
                The study was a double-blind, placebo-controlled trial. Patients with proven CL were treated with ketoconazole cream or placebo cream. The duration of treatment was 21 days and the patients were visited on days 7, 14 and 21. Follow-up was for 1 month after the end of treatment.
                The study was completed in 73 patients (45 male, 28 female). The mean age of the patients was 19.9 years. A total of 38 patients received ketoconazole and 35 patients were treated with the placebo cream. At the end of treatment (day 21), complete healing had occurred in 15.7% of the ketoconazole group in comparison with 14.3% of the patients who were treated with the placebo cream (p=0.86). One month after the end of treatment the lesions in 28.9% of the ketoconazole group and 22.8% of the placebo group were healed (p=0.55).
                Although the ketoconazole tablet has been reported to be effective in the treatment of some cases of CL, the low response rate in patients receiving ketoconazole cream indicates that it cannot be used as the single agent in the treatment of CL patients. The objective of this study was to compare the efficacy of a combination of allopurinol (AL) and low-dose meglumine antimoniate (MA) with standard-dose MA in cutaneous leishmaniasis caused by Leishmania major. An open, controlled study was performed. Seventy-two patients were randomly selected from volunteers with cutaneous leishmaniasis living in a hyperendemic area. Exclusion criteria included pregnancy, nursing vs. gestation, age less than 5 years, and duration of disease of more than 4 months. Each patient received MA (60 mg/kg/day) or AL (20 mg/kg/day) plus low-dose MA (30 mg/kg/day) for 20 days, and was followed up for 30 days after cessation of treatment. The study was completed as planned in 66 patients. Complete healing occurred in 74.2% of patients in the MA group and in 80.6% of patients in the MA + AL group. No difference was found between the two groups with respect to side-effects. The combination of AL and MA increases the anti-leishmanial effects of antimoniate. In this study, it was confirmed that low-dose MA plus AL is as effective as high-dose MA in the treatment of cutaneous leishmaniasis caused by L. major. The various methods used to treat cutaneous leishmaniasis (CL) have not given consistent results. The aim of the present study was to compare the efficacy of a solution of meglumine antimoniate (MA; 85 mg Sb/ml) given intralesionally (i.l.) with that of the same solution given intramuscularly (i.m.). Eighty CL patients, with a total of 147 lesions, were randomly allocated into the two treatment groups. Forty were injected i.m. with MA (15 mg Sb/kg.day) on 6 days/week until 12 injections had been given to each. The lesions of the other 40 patients were infiltrated with MA (0.2-0.8 ml/lesion) every other day for 30 days. After 15 days' therapy, none of the lesions on those treated i.m. had fully healed (although five lesions showed some improvement) whereas two lesions on those treated i.l. had fully healed and 10 showed good improvement. After 30 days, 46 (68%) of the 68 lesions on those treated i.m. had healed completely, 11 (16%) had improved, and five (8%) worsened. The corresponding values for the 66 lesions on those treated i.l. were 48 (73%), 10 (15%) and three (5%). There was no statistically significant difference between the two treatment groups, either in terms of satisfactory response (lesions fully healed or improved) or unsatisfactory response (lesions unchanged or advanced), when assessed on day 30 (P > 0.5). Intralesional antimony is a rapidly effective, safe and economical method of treating simple CL, particularly in patients with cardiac, liver or renal disease, for whom antimonials are contra-indicated.
Most trials have been designed and reported poorly, resulting in a lack of evidence for potentially beneficial treatments. There is a desperate need for large well conducted studies that evaluate long-term effects of current therapies. We suggest the creation of an international platform to improve quality and standardization of future trials in order to inform clinical practice.