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Review
. 2017 Dec 1;12(12):CD005067.
doi: 10.1002/14651858.CD005067.pub5.

Interventions for Old World cutaneous leishmaniasis

Julio Heras-Mosteiro  1 , Begoña Monge-Maillo, Mariona Pinart, Patricia Lopez Pereira, Ludovic Reveiz, Emely Garcia-Carrasco, Pedro Campuzano Cuadrado, Ana Royuela, Irene Mendez Roman, Rogelio López-Vélez
Affiliations
Review

Interventions for Old World cutaneous leishmaniasis

Julio Heras-Mosteiro et al. Cochrane Database Syst Rev. .

Abstract

Background: Cutaneous leishmaniasis, caused by a parasitic infection, is considered one of the most serious skin diseases in many low- and middle-income countries. Old World cutaneous leishmaniasis (OWCL) is caused by species found in Africa, Asia, the Middle East, the Mediterranean, and India. The most commonly prescribed treatments are antimonials, but other drugs have been used with varying success. As OWCL tends to heal spontaneously, it is necessary to justify the use of systemic and topical treatments. This is an update of a Cochrane Review first published in 2008.

Objectives: To assess the effects of therapeutic interventions for the localised form of Old World cutaneous leishmaniasis.

Search methods: We updated our searches of the following databases to November 2016: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers and checked the reference lists of included studies for further references to relevant randomised controlled trials (RCTs). We wrote to national programme managers, general co-ordinators, directors, clinicians, WHO-EMRO regional officers of endemic countries, pharmaceutical companies, tropical medicine centres, and authors of relevant papers for further information about relevant unpublished and ongoing trials. We undertook a separate search for adverse effects of interventions for Old World cutaneous leishmaniasis in September 2015 using MEDLINE.

Selection criteria: Randomised controlled trials of either single or combination treatments in immunocompetent people with OWCL confirmed by smear, histology, culture, or polymerase chain reaction. The comparators were either no treatment, placebo/vehicle, and/or another active compound.

Data collection and analysis: Two review authors independently assessed trials for inclusion and risk of bias and extracted data. We only synthesised data when we were able to identify at least two studies investigating similar treatments and reporting data amenable to pooling. We also recorded data about adverse effects from the corresponding search.

Main results: We included 89 studies (of which 40 were new to this update) in 10,583 people with OWCL. The studies included were conducted mainly in the Far or Middle East at regional hospitals, local healthcare clinics, and skin disease research centres. Women accounted for 41.5% of the participants (range: 23% to 80%). The overall mean age of participants was 25 years (range 12 to 56). Most studies lasted between two to six months, with the longest lasting two years; average duration was four months. Most studies were at unclear or high risk for most bias domains. A lack of blinding and reporting bias were present in almost 40% of studies. Two trials were at low risk of bias for all domains. Trials reported the causative species poorly.Here we provide results for the two main comparisons identified: itraconazole (200 mg for six to eight weeks) versus placebo; and paromomycin ointment (15% plus 10% urea, twice daily for 14 days) versus vehicle.In the comparison of oral itraconazole versus placebo, at 2.5 months' follow up, 85/125 participants in the itraconazole group achieved complete cure compared to 54/119 in the placebo group (RR 3.70, 95% CI 0.35 to 38.99; 3 studies; 244 participants). In one study, microbiological or histopathological cure of skin lesions only occurred in the itraconazole group after a mean follow-up of 2.5 months (RR 17.00, 95% CI 0.47 to 612.21; 20 participants). However, although the analyses favour oral itraconazole for these outcomes, we cannot be confident in the results due to the very low certainty evidence. More side effects of mild abdominal pain and nausea (RR 2.36, 95% CI 0.74 to 7.47; 3 studies; 204 participants) and mild abnormal liver function (RR 3.08, 95% CI 0.53 to 17.98; 3 studies; 84 participants) occurred in the itraconazole group (as well as reports of headaches and dizziness), compared with the placebo group, but again we rated the certainty of evidence as very low so are unsure of the results.When comparing paromomycin with vehicle, there was no difference in the number of participants who achieved complete cure (RR of 1.00, 95% CI 0.86, 1.17; 383 participants, 2 studies) and microbiological or histopathological cure of skin lesions after a mean follow-up of 2.5 months (RR 1.03, CI 0.88 to 1.20; 383 participants, 2 studies), but the paromomycin group had more skin/local reactions (such as inflammation, vesiculation, pain, redness, or itch) (RR 1.42, 95% CI 0.67 to 3.01; 4 studies; 713 participants). For all of these outcomes, the certainty of evidence was very low, meaning we are unsure about these results.Trial authors did not report the percentage of lesions cured after the end of treatment or speed of healing for either of these key comparisons.

Authors' conclusions: There was very low-certainty evidence to support the effectiveness of itraconazole and paromomycin ointment for OWCL in terms of cure (i.e. microbiological or histopathological cure and percentage of participants completely cured). Both of these interventions incited more adverse effects, which were mild in nature, than their comparisons, but we could draw no conclusions regarding safety due to the very low certainty of the evidence for this outcome.We downgraded the key outcomes in these two comparisons due to high risk of bias, inconsistency between the results, and imprecision. There is a need for large, well-designed international studies that evaluate long-term effects of current therapies and enable a reliable conclusion about treatments. Future trials should specify the species of leishmaniasis; trials on types caused by Leishmania infantum, L aethiopica, andL donovani are lacking. Research into the effects of treating women of childbearing age, children, people with comorbid conditions, and those who are immunocompromised would also be helpful.It was difficult to evaluate the overall efficacy of any of the numerous treatments due to the variable treatment regimens examined and because RCTs evaluated different Leishmania species and took place in different geographical areas. Some outcomes we looked for but did not find were degree of functional and aesthetic impairment, change in ability to detect Leishmania, quality of life, and emergence of resistance. There were only limited data on prevention of scarring.

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Conflict of interest statement

Julio Heras‐Mosteiro: none known. Begoña Monge‐Maillo: none known. Mariona Pinart: none known. Patricia Lopez Pereira: none known. Ludovic Reveiz: none known. Ludovic Reveiz has contributed to this review in a personal capacity and during his spare time. The views and opinions expressed herein are those of the review authors and do not necessarily reflect those of the organisation where he works. Emely Garcia‐Carrasco: none known. Pedro Campuzano Cuadrado: none known. Ana Royuela: none known. Irene Mendez Roman: none known. Rogelio López‐Vélez: none known.

Iraj Sharifi, one of the clinical referees, was a co‐author on the included studies Khatami 2012 and Daie Parizi 2015.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgments about each risk of bias item for each included study.
3
3
Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included studies.
4
4
Forest Plot of Primary Outcome: Lesions Cured (Various comparisons)
5
5
Forest plot of primary outcome: 1.2 Participants cured (Various comparisons)
1.1
1.1. Analysis
Comparison 1 ILMA weekly versus ILMA fortnightly for up to 8 weeks, Outcome 1 Lesions cured.
2.1
2.1. Analysis
Comparison 2 ILMA (every other day) versus IMMA (6 d/week) for up to 4 weeks, Outcome 1 Lesions cured.
3.1
3.1. Analysis
Comparison 3 IMMA (30 mg/kg/d for 3 weeks) + cimetidine versus IMMA (30 mg/kg/d for 3 weeks) + placebo, Outcome 1 Lesions cured.
4.1
4.1. Analysis
Comparison 4 IMMA (30 mg/kg/d for 3 weeks) + cimetidine versus IMMA (60 mg/kg/d for 3 weeks) + placebo, Outcome 1 Lesions cured.
5.1
5.1. Analysis
Comparison 5 IMMA (60 mg/kg/d for 3 weeks) + placebo versus IMMA (30 mg/kg/d for 3 weeks) + placebo, Outcome 1 Lesions cured.
6.1
6.1. Analysis
Comparison 6 IMMA (30 mg/kg/d for 3 weeks) + placebo versus IMMA (60 mg/kg/d for 3 weeks) + placebo, Outcome 1 Participants complete cure.
6.2
6.2. Analysis
Comparison 6 IMMA (30 mg/kg/d for 3 weeks) + placebo versus IMMA (60 mg/kg/d for 3 weeks) + placebo, Outcome 2 Adverse effects.
7.1
7.1. Analysis
Comparison 7 IMMA (30 mg/kg/d for 3 weeks) + 40 mg omeprazole versus IMMA (60 mg/kg/d for 3 weeks) + placebo, Outcome 1 Participants complete cure.
8.1
8.1. Analysis
Comparison 8 IMMA (30 mg/kg/d for 3 weeks) + placebo versus IMMA (60 mg/kg/d for 3 weeks) + placebo, Outcome 1 Participants complete cure.
9.1
9.1. Analysis
Comparison 9 IMMA (30 mg/kg/d for 3 weeks) + 40 mg omeprazole versus IMMA (60 mg/kg/d for 3 weeks) + placebo, Outcome 1 Participants complete cure.
10.1
10.1. Analysis
Comparison 10 ILMA + non‐silver polyester dressing versus ILMA (weekly injections for 6 weeks), Outcome 1 Lesions cured.
10.2
10.2. Analysis
Comparison 10 ILMA + non‐silver polyester dressing versus ILMA (weekly injections for 6 weeks), Outcome 2 Adverse effects (itching and burning).
10.3
10.3. Analysis
Comparison 10 ILMA + non‐silver polyester dressing versus ILMA (weekly injections for 6 weeks), Outcome 3 Adverse effects (oedema).
11.1
11.1. Analysis
Comparison 11 ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks), Outcome 1 Lesions cured.
11.2
11.2. Analysis
Comparison 11 ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks), Outcome 2 Adverse effects (itching and burning).
11.3
11.3. Analysis
Comparison 11 ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks), Outcome 3 Adverse effects (oedema).
12.1
12.1. Analysis
Comparison 12 ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks) + non‐silver polyester dressing, Outcome 1 Lesions cured.
12.2
12.2. Analysis
Comparison 12 ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks) + non‐silver polyester dressing, Outcome 2 Adverse effects (itching and burning).
12.3
12.3. Analysis
Comparison 12 ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks) + non‐silver polyester dressing, Outcome 3 Adverse effects (oedema).
13.1
13.1. Analysis
Comparison 13 ILMA (weekly injections for 6 weeks) + gel mask twice a day versus ILMA (weekly injections for 6 weeks) + vehicle, Outcome 1 Participants complete cure.
14.1
14.1. Analysis
Comparison 14 ILSSG (20 mg/kg/d) + IMSSG (remaining total dose days 1, 3, 5) versus ILSSG (1000 mg/mL days 1, 3, 5), Outcome 1 Lesions cured.
15.1
15.1. Analysis
Comparison 15 ILSSG (5 injections of 2 mL to 5 mL every 5 to 7 d for 29 days) versus IMSSG (20 mg/kg/d for 3 weeks), Outcome 1 Participants complete cure.
15.2
15.2. Analysis
Comparison 15 ILSSG (5 injections of 2 mL to 5 mL every 5 to 7 d for 29 days) versus IMSSG (20 mg/kg/d for 3 weeks), Outcome 2 Adverse effects (mild heart symptoms).
16.1
16.1. Analysis
Comparison 16 Ketoconazole 600 mg/d for 6 weeks versus ketoconazole 800 mg/d for 6 weeks, Outcome 1 Participants complete cure.
16.2
16.2. Analysis
Comparison 16 Ketoconazole 600 mg/d for 6 weeks versus ketoconazole 800 mg/d for 6 weeks, Outcome 2 Adverse effects (nausea and vomiting).
17.1
17.1. Analysis
Comparison 17 Ketoconazole 600 mg/d for 30 d versus ILMA (6 to 8 biweekly injections), Outcome 1 Participants cured.
17.2
17.2. Analysis
Comparison 17 Ketoconazole 600 mg/d for 30 d versus ILMA (6 to 8 biweekly injections), Outcome 2 Adverse effect (liver enzymes increase).
18.1
18.1. Analysis
Comparison 18 ILSSG (100 mg/mL days 1, 3, 5) + oral ketoconazole (600 mg/d for 4 weeks) versus ILSSG (100 mg/mL days 1, 3, 5), Outcome 1 Lesions cured.
19.1
19.1. Analysis
Comparison 19 ILSSG (100 mg/mL days 1, 3, 5) + ketoconazole (600 mg/d for 4 weeks) versus ILSSG (20 mg/kg/d) + IMSSG (remaining total dose days 1, 3, 5), Outcome 1 Lesions cured.
20.1
20.1. Analysis
Comparison 20 Itraconazole (200 mg for 6 weeks) versus placebo, Outcome 1 Participants complete cure.
21.1
21.1. Analysis
Comparison 21 Itraconazole (200 mg for 3 weeks) versus placebo, Outcome 1 Participants complete cure.
22.1
22.1. Analysis
Comparison 22 Itraconazole (200 mg for 6 to 8 weeks) versus placebo, Outcome 1 Participants complete cure.
22.2
22.2. Analysis
Comparison 22 Itraconazole (200 mg for 6 to 8 weeks) versus placebo, Outcome 2 Adverse effects.
22.3
22.3. Analysis
Comparison 22 Itraconazole (200 mg for 6 to 8 weeks) versus placebo, Outcome 3 Microbiological cure of skin lesions.
23.1
23.1. Analysis
Comparison 23 Itraconazole (200 mg for 6 to 8 weeks) versus no treatment, Outcome 1 Participants complete cure.
23.2
23.2. Analysis
Comparison 23 Itraconazole (200 mg for 6 to 8 weeks) versus no treatment, Outcome 2 Adverse effects (headache and dizziness).
23.3
23.3. Analysis
Comparison 23 Itraconazole (200 mg for 6 to 8 weeks) versus no treatment, Outcome 3 Microbiological cure of skin lesions.
24.1
24.1. Analysis
Comparison 24 Fluconazole (200 mg for 6 weeks) versus placebo, Outcome 1 Lesions cured.
24.2
24.2. Analysis
Comparison 24 Fluconazole (200 mg for 6 weeks) versus placebo, Outcome 2 Participants complete cure.
25.1
25.1. Analysis
Comparison 25 Fluconazole (400 mg/d for 6 weeks) versus fluconazole (200 mg/d for 6 weeks), Outcome 1 Participants complete cure.
25.2
25.2. Analysis
Comparison 25 Fluconazole (400 mg/d for 6 weeks) versus fluconazole (200 mg/d for 6 weeks), Outcome 2 Adverse effects.
26.1
26.1. Analysis
Comparison 26 Oral dapsone (200 mg/d for 6 weeks) versus placebo, Outcome 1 Participants complete Cure.
26.2
26.2. Analysis
Comparison 26 Oral dapsone (200 mg/d for 6 weeks) versus placebo, Outcome 2 Adverse effects.
27.1
27.1. Analysis
Comparison 27 Allopurinol (15 mg/kg/d for 3 weeks) + IMMA (20 mg/kg/d for 2 weeks) versus allopurinol (15 mg/kg/d for 3 weeks), Outcome 1 Lesions cured.
28.1
28.1. Analysis
Comparison 28 Allopurinol (15mg/kg/d for 3 weeks)+ IMMA (20 mg/kg/d for 2 weeks) versus IMMA (20 mg/kg/d for 2 weeks), Outcome 1 Lesions cured.
29.1
29.1. Analysis
Comparison 29 Allopurinol (15 mg/kg/d for 3 weeks) versus IMMA (20 mg/kg/d for 2 weeks), Outcome 1 Lesions Cured.
30.1
30.1. Analysis
Comparison 30 Allopurinol (20 mg/kg/d for 3 weeks) + IMMA (30 mg/kg/d for 20 days) versus IMMA (60 mg/kg/d for 20 d), Outcome 1 Lesions cured.
30.2
30.2. Analysis
Comparison 30 Allopurinol (20 mg/kg/d for 3 weeks) + IMMA (30 mg/kg/d for 20 days) versus IMMA (60 mg/kg/d for 20 d), Outcome 2 Adverse effects.
30.3
30.3. Analysis
Comparison 30 Allopurinol (20 mg/kg/d for 3 weeks) + IMMA (30 mg/kg/d for 20 days) versus IMMA (60 mg/kg/d for 20 d), Outcome 3 Microbiological cure of skin lesions.
31.1
31.1. Analysis
Comparison 31 Allopurinol (20 mg/kg/d for 3 weeks)+ IMMA (10 mg/kg/d for 20 d) versus IMMA (20 mg/kg/d for 28 d), Outcome 1 Adverse effects.
32.1
32.1. Analysis
Comparison 32 Allopurinol (20 mg/kg/d for 3 weeks) versus IVSSG (20 mg/kg/d for 15 d), Outcome 1 Participants complete cured.
32.2
32.2. Analysis
Comparison 32 Allopurinol (20 mg/kg/d for 3 weeks) versus IVSSG (20 mg/kg/d for 15 d), Outcome 2 Adverse effects.
33.1
33.1. Analysis
Comparison 33 Oral rifampicin (10 mg/kg/d for 4 to 6 weeks) versus placebo, Outcome 1 Participants complete cure.
33.2
33.2. Analysis
Comparison 33 Oral rifampicin (10 mg/kg/d for 4 to 6 weeks) versus placebo, Outcome 2 Microbiological cure of skin lesions.
34.1
34.1. Analysis
Comparison 34 Oral rifampicin (10 mg/kg/d) + omeprazole (20 mg/d) for 6 weeks versus placebo, Outcome 1 Participants complete cure.
35.1
35.1. Analysis
Comparison 35 Azythromicin (500 mg/d for 5 d/month up to 4 months) versus IMMA (60 mg/kg/d for 20 d), Outcome 1 Lesions cured.
35.2
35.2. Analysis
Comparison 35 Azythromicin (500 mg/d for 5 d/month up to 4 months) versus IMMA (60 mg/kg/d for 20 d), Outcome 2 Adverse effects.
36.1
36.1. Analysis
Comparison 36 Azythromicin (10 mg/kg/d) + allopurinol (10 mg/kg/d) for 1 month versus IMMA (20 mg/kg/d for 20 d), Outcome 1 Participants complete cure.
36.2
36.2. Analysis
Comparison 36 Azythromicin (10 mg/kg/d) + allopurinol (10 mg/kg/d) for 1 month versus IMMA (20 mg/kg/d for 20 d), Outcome 2 Adverse effects.
37.1
37.1. Analysis
Comparison 37 Oral pentoxifylline (400 mg 3 times daily) + IMMA (20 mg/kg/d) for 20 d versus placebo + IMMA (20 mg/kg/d) for 20 d, Outcome 1 Participants complete cure.
37.2
37.2. Analysis
Comparison 37 Oral pentoxifylline (400 mg 3 times daily) + IMMA (20 mg/kg/d) for 20 d versus placebo + IMMA (20 mg/kg/d) for 20 d, Outcome 2 Adverse effects.
38.1
38.1. Analysis
Comparison 38 Oral miltefosine (2.5 mg/kg/d for 4 weeks) versus IMMA (60 mg/kg/d for 2 weeks), Outcome 1 Participants complete cure.
39.1
39.1. Analysis
Comparison 39 Oral miltefosine (2.5 mg/kg/d for 4 weeks) versus IMMA (60 mg/kg/d for 2 weeks), Outcome 1 Participants complete cure.
40.1
40.1. Analysis
Comparison 40 Oral zinc sulphate 2.5 mg/kg/d for 45 days versus oral zinc sulphate 5 mg/kg/d for 45 d, Outcome 1 Participants complete cure.
40.2
40.2. Analysis
Comparison 40 Oral zinc sulphate 2.5 mg/kg/d for 45 days versus oral zinc sulphate 5 mg/kg/d for 45 d, Outcome 2 Adverse effects.
41.1
41.1. Analysis
Comparison 41 Oral zinc sulphate 2.5 mg/kg/d for 45 d versus oral zinc sulphate 10 mg/kg/d for 45 d, Outcome 1 Participants complete cure.
41.2
41.2. Analysis
Comparison 41 Oral zinc sulphate 2.5 mg/kg/d for 45 d versus oral zinc sulphate 10 mg/kg/d for 45 d, Outcome 2 Adverse effects.
42.1
42.1. Analysis
Comparison 42 Oral zinc sulphate 5 mg/kg/d for 45 d versus oral zinc sulphate 10 mg/kg/d for 45 d, Outcome 1 Participants complete cure.
42.2
42.2. Analysis
Comparison 42 Oral zinc sulphate 5 mg/kg/d for 45 d versus oral zinc sulphate 10 mg/kg/d for 45 d, Outcome 2 Adverse effects.
43.1
43.1. Analysis
Comparison 43 Oral zinc sulphate (10 mg/kg/d for 45 d) versus IMMA (20 mg/kg/d for 20 d), Outcome 1 Participants complete cure.
44.1
44.1. Analysis
Comparison 44 Artesunate 400 mg + sulphamethoxypyrazine/pyrimethamine 1000 mg/50 mg 4 times daily for 4 d versus placebo, Outcome 1 Participants complete cure.
45.1
45.1. Analysis
Comparison 45 Topical 2% miconazole (twice a day) versus topical 1% clotrimazole (twice a day) for 30 d, Outcome 1 Lesions cured.
46.1
46.1. Analysis
Comparison 46 Topical ketoconazole (twice a day) versus vehicle (twice a day) for 30 d, Outcome 1 Participants complete cure.
47.1
47.1. Analysis
Comparison 47 Topical amphotericin B (3 to 7 drops twice daily for 8 weeks) versus ILMA (max 2 mL) once a week for 8 weeks, Outcome 1 Participants complete cure (ITT).
47.2
47.2. Analysis
Comparison 47 Topical amphotericin B (3 to 7 drops twice daily for 8 weeks) versus ILMA (max 2 mL) once a week for 8 weeks, Outcome 2 Adverse effects.
48.1
48.1. Analysis
Comparison 48 Paromomycin 15% + 12% MBCL (twice daily for 28 d) versus vehicle (twice daily for 28 d), Outcome 1 Lesions cured.
48.2
48.2. Analysis
Comparison 48 Paromomycin 15% + 12% MBCL (twice daily for 28 d) versus vehicle (twice daily for 28 d), Outcome 2 Scarring.
48.3
48.3. Analysis
Comparison 48 Paromomycin 15% + 12% MBCL (twice daily for 28 d) versus vehicle (twice daily for 28 d), Outcome 3 Microbiological cure of skin lesions.
49.1
49.1. Analysis
Comparison 49 Paromomycin (twice daily for 30 d) versus vehicle (twice daily for 30 d), Outcome 1 Lesions cured.
50.1
50.1. Analysis
Comparison 50 Paromomycin 15% + 10% urea (twice daily for 14 d) versus vehicle (twice daily for 14 d), Outcome 1 Participants complete cure.
50.2
50.2. Analysis
Comparison 50 Paromomycin 15% + 10% urea (twice daily for 14 d) versus vehicle (twice daily for 14 d), Outcome 2 Adverse effects.
50.3
50.3. Analysis
Comparison 50 Paromomycin 15% + 10% urea (twice daily for 14 d) versus vehicle (twice daily for 14 d), Outcome 3 Microbiological cure of skin lesions.
51.1
51.1. Analysis
Comparison 51 Paromomycin 15% (daily for 20 d) versus vehicle, Outcome 1 Participants complete cure.
52.1
52.1. Analysis
Comparison 52 Paromomycin 15% + gentamicin 0.5% (daily for 20 d) versus vehicle, Outcome 1 Participants complete cure.
53.1
53.1. Analysis
Comparison 53 Paromomycin 15% + gentamicin 0.5% (daily for 20 d) versus paromomycin 15% alone (daily for 20 d), Outcome 1 Participants complete cure.
54.1
54.1. Analysis
Comparison 54 Paromomycin 15% + 10% urea (twice daily for 45 d) versus ILMA (weekly for up to 3 months), Outcome 1 Participants complete cure.
54.2
54.2. Analysis
Comparison 54 Paromomycin 15% + 10% urea (twice daily for 45 d) versus ILMA (weekly for up to 3 months), Outcome 2 Recurrence.
54.3
54.3. Analysis
Comparison 54 Paromomycin 15% + 10% urea (twice daily for 45 d) versus ILMA (weekly for up to 3 months), Outcome 3 Scarring.
55.1
55.1. Analysis
Comparison 55 Paromomycin 15% + 10% urea (twice daily for 20 d) versus ILMA (weekly for up to 20 d), Outcome 1 Participants complete cure.
55.2
55.2. Analysis
Comparison 55 Paromomycin 15% + 10% urea (twice daily for 20 d) versus ILMA (weekly for up to 20 d), Outcome 2 Adverse effects.
56.1
56.1. Analysis
Comparison 56 Paromomycin + MBCL (twice daily for 15 d) versus ketoconazole (weekly for up to 30 d), Outcome 1 Participants complete cure.
56.2
56.2. Analysis
Comparison 56 Paromomycin + MBCL (twice daily for 15 d) versus ketoconazole (weekly for up to 30 d), Outcome 2 Microbiological cure of skin lesions.
57.1
57.1. Analysis
Comparison 57 Paromomycin (15% + 12% MBCL twice daily for 28 days) versus PDT (weekly for 4 weeks), Outcome 1 Lesions cured.
57.2
57.2. Analysis
Comparison 57 Paromomycin (15% + 12% MBCL twice daily for 28 days) versus PDT (weekly for 4 weeks), Outcome 2 Scarring.
57.3
57.3. Analysis
Comparison 57 Paromomycin (15% + 12% MBCL twice daily for 28 days) versus PDT (weekly for 4 weeks), Outcome 3 Microbiological cure of skin lesions.
58.1
58.1. Analysis
Comparison 58 Paromomycin (4 weeks) versus paromomycin (2 weeks) + vehicle (2 weeks), Outcome 1 Participants complete cure.
58.2
58.2. Analysis
Comparison 58 Paromomycin (4 weeks) versus paromomycin (2 weeks) + vehicle (2 weeks), Outcome 2 Microbiological cure of skin lesions.
59.1
59.1. Analysis
Comparison 59 IL zinc 2% (twice a week for 2 weeks) versus ILSSG (100 mg/mL) for 2 weeks), Outcome 1 Lesions cured.
60.1
60.1. Analysis
Comparison 60 IL zinc 2% (twice a week for 2 weeks) versus IL 7% HSCS for 2 weeks, Outcome 1 Lesions cured.
61.1
61.1. Analysis
Comparison 61 ILSSG (100 mg/mL) for 2 weeks versus IL 7% HSCS for 2 weeks, Outcome 1 Lesions cured.
62.1
62.1. Analysis
Comparison 62 IL zinc 2% (weekly for up to 6 weeks) versus ILMA (max 2 mL weekly for up to 6 weeks), Outcome 1 Lesions cured.
62.2
62.2. Analysis
Comparison 62 IL zinc 2% (weekly for up to 6 weeks) versus ILMA (max 2 mL weekly for up to 6 weeks), Outcome 2 Participants complete cured.
62.3
62.3. Analysis
Comparison 62 IL zinc 2% (weekly for up to 6 weeks) versus ILMA (max 2 mL weekly for up to 6 weeks), Outcome 3 Adverse effects.
63.1
63.1. Analysis
Comparison 63 IL zinc 2% (twice a week for 2 weeks) versus ILMA (60 mg/kg/d for 2 weeks), Outcome 1 Lesions cured.
63.2
63.2. Analysis
Comparison 63 IL zinc 2% (twice a week for 2 weeks) versus ILMA (60 mg/kg/d for 2 weeks), Outcome 2 Adverse effects.
64.1
64.1. Analysis
Comparison 64 Imiquimod (5% 3 times/week for 28 d) + IMMA (20 mg/kg/d for 14 d) versus vehicle + IMMA, Outcome 1 Participants complete cure.
64.2
64.2. Analysis
Comparison 64 Imiquimod (5% 3 times/week for 28 d) + IMMA (20 mg/kg/d for 14 d) versus vehicle + IMMA, Outcome 2 Participants with treated lesions that recur.
64.3
64.3. Analysis
Comparison 64 Imiquimod (5% 3 times/week for 28 d) + IMMA (20 mg/kg/d for 14 d) versus vehicle + IMMA, Outcome 3 Adverse effects.
65.1
65.1. Analysis
Comparison 65 IL 7% HSCS (0.2 mL to 7 mL per lesion) versus ILSSG (max 2 mL) max 5 injections, Outcome 1 Lesions cured.
66.1
66.1. Analysis
Comparison 66 IL 5% HSCS (0.5 mL to 1 mL per lesion) versus ILMA (0.5 mL to 1 mL per lesion) weekly for 6 to 10 weeks, Outcome 1 Lesions cured.
66.2
66.2. Analysis
Comparison 66 IL 5% HSCS (0.5 mL to 1 mL per lesion) versus ILMA (0.5 mL to 1 mL per lesion) weekly for 6 to 10 weeks, Outcome 2 Adverse effects.
67.1
67.1. Analysis
Comparison 67 IL 7% HSCS (0.1 mL to 0.5 mL per lesion) versus IL 2% ciprofloxacin solution (0.1 mL to 0.5 mL per lesion), Outcome 1 Lesions cured.
68.1
68.1. Analysis
Comparison 68 IL 15% HSCS (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 1 Lesions cured.
68.2
68.2. Analysis
Comparison 68 IL 15% HSCS (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 2 Recurrence.
68.3
68.3. Analysis
Comparison 68 IL 15% HSCS (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 3 Speed of healing (weeks).
68.4
68.4. Analysis
Comparison 68 IL 15% HSCS (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 4 Adverse effects.
69.1
69.1. Analysis
Comparison 69 ILSSG (0.2 mL to 4 mL per lesion) max 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 1 Lesions cured.
69.2
69.2. Analysis
Comparison 69 ILSSG (0.2 mL to 4 mL per lesion) max 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 2 Recurrence.
69.3
69.3. Analysis
Comparison 69 ILSSG (0.2 mL to 4 mL per lesion) max 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 3 Speed of healing (weeks).
69.4
69.4. Analysis
Comparison 69 ILSSG (0.2 mL to 4 mL per lesion) max 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 4 Adverse effects.
70.1
70.1. Analysis
Comparison 70 ILSSG (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 15% HSCS (0.2 mL to 4 mL per lesion), Outcome 1 Lesions cured.
70.2
70.2. Analysis
Comparison 70 ILSSG (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 15% HSCS (0.2 mL to 4 mL per lesion), Outcome 2 Recurrence.
70.3
70.3. Analysis
Comparison 70 ILSSG (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 15% HSCS (0.2 mL to 4 mL per lesion), Outcome 3 Speed of healing (weeks).
70.4
70.4. Analysis
Comparison 70 ILSSG (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 15% HSCS (0.2 mL to 4 mL per lesion), Outcome 4 Adverse effects.
71.1
71.1. Analysis
Comparison 71 IL IFN‐γ (weekly for 5 weeks) versus ILMA (0.5 mL to 1 mL per lesion) weekly for 5 weeks, Outcome 1 Lesions cured.
71.2
71.2. Analysis
Comparison 71 IL IFN‐γ (weekly for 5 weeks) versus ILMA (0.5 mL to 1 mL per lesion) weekly for 5 weeks, Outcome 2 Microbiological cure of skin lesions.
72.1
72.1. Analysis
Comparison 72 WR279,396 (twice a day for 20 d) versus vehicle (twice a day for 20 d), Outcome 1 Participants complete cure.
72.2
72.2. Analysis
Comparison 72 WR279,396 (twice a day for 20 d) versus vehicle (twice a day for 20 d), Outcome 2 Adverse effects.
73.1
73.1. Analysis
Comparison 73 IL metronidazole (2.5 mg to 10 mg each lesion) versus ILMA (150 mg to 600 mg each lesion) for up to 8 weeks, Outcome 1 Participants complete cure.
73.2
73.2. Analysis
Comparison 73 IL metronidazole (2.5 mg to 10 mg each lesion) versus ILMA (150 mg to 600 mg each lesion) for up to 8 weeks, Outcome 2 Adverse effects.
74.1
74.1. Analysis
Comparison 74 Topical miltefosine 6% (once daily) versus ILMA (twice a week) for up to 28 d, Outcome 1 Participants complete cure.
75.1
75.1. Analysis
Comparison 75 Dapsone gel 5% (twice a day) + ILMA (weekly) versus cryotherapy (every 2 weeks) + IMMA (weekly) for up to 16 weeks, Outcome 1 Lesions cured.
76.1
76.1. Analysis
Comparison 76 DAC‐055 + MWT (for 15 min) versus DAC‐055 alone for up to 75 d, Outcome 1 Participants complete cure.
76.2
76.2. Analysis
Comparison 76 DAC‐055 + MWT (for 15 min) versus DAC‐055 alone for up to 75 d, Outcome 2 Adverse effects.
77.1
77.1. Analysis
Comparison 77 DAC‐055 + heat (for 15 min) versus ILSSG (0.6 mL) for up to 75 d, Outcome 1 Participants complete cure.
77.2
77.2. Analysis
Comparison 77 DAC‐055 + heat (for 15 min) versus ILSSG (0.6 mL) for up to 75 d, Outcome 2 Adverse effects.
78.1
78.1. Analysis
Comparison 78 DAC‐055 alone (for 15 min) versus ILSSG (0.6 mL) for up to 75 d, Outcome 1 Participants complete cure.
78.2
78.2. Analysis
Comparison 78 DAC‐055 alone (for 15 min) versus ILSSG (0.6 mL) for up to 75 d, Outcome 2 Adverse effects.
79.1
79.1. Analysis
Comparison 79 Thio‐Ben (1 mL to 2 mL daily) + cryotherapy (fortnightly) versus ILMA (0.5 mL to 2 mL per lesions) weekly + cryotherapy (fortnightly) for up to 12 weeks, Outcome 1 Lesions cured.
79.2
79.2. Analysis
Comparison 79 Thio‐Ben (1 mL to 2 mL daily) + cryotherapy (fortnightly) versus ILMA (0.5 mL to 2 mL per lesions) weekly + cryotherapy (fortnightly) for up to 12 weeks, Outcome 2 Recurrence.
79.3
79.3. Analysis
Comparison 79 Thio‐Ben (1 mL to 2 mL daily) + cryotherapy (fortnightly) versus ILMA (0.5 mL to 2 mL per lesions) weekly + cryotherapy (fortnightly) for up to 12 weeks, Outcome 3 Adverse effects.
80.1
80.1. Analysis
Comparison 80 CO₂ laser (30 W continuous) versus IMMA (50 mg/kg/d) for up to 15 d, Outcome 1 Lesions cured.
80.2
80.2. Analysis
Comparison 80 CO₂ laser (30 W continuous) versus IMMA (50 mg/kg/d) for up to 15 d, Outcome 2 Adverse effects.
81.1
81.1. Analysis
Comparison 81 CO₂ laser (30 W continuous) versus cryotherapy (fortnightly) + ILMA (weekly) for up to 12 weeks, Outcome 1 Lesions cured.
81.2
81.2. Analysis
Comparison 81 CO₂ laser (30 W continuous) versus cryotherapy (fortnightly) + ILMA (weekly) for up to 12 weeks, Outcome 2 Adverse effects.
82.1
82.1. Analysis
Comparison 82 Ablative CO₂ laser (25 kW for 1 session) versus 3 weeks fractional CO₂ laser, Outcome 1 Partcipants complete cure.
82.2
82.2. Analysis
Comparison 82 Ablative CO₂ laser (25 kW for 1 session) versus 3 weeks fractional CO₂ laser, Outcome 2 Adverse effects.
83.1
83.1. Analysis
Comparison 83 TCA (50% wt/vol) fortnightly up to 3 times versus ILMA alone (weekly for up to 6 weeks), Outcome 1 Participants complete cure.
83.2
83.2. Analysis
Comparison 83 TCA (50% wt/vol) fortnightly up to 3 times versus ILMA alone (weekly for up to 6 weeks), Outcome 2 Recurrence.
83.3
83.3. Analysis
Comparison 83 TCA (50% wt/vol) fortnightly up to 3 times versus ILMA alone (weekly for up to 6 weeks), Outcome 3 Adverse effects.
83.4
83.4. Analysis
Comparison 83 TCA (50% wt/vol) fortnightly up to 3 times versus ILMA alone (weekly for up to 6 weeks), Outcome 4 Microbiological cure of skin lesions.
84.1
84.1. Analysis
Comparison 84 Topical TCA 50% + local heat versus ILMA twice a week for up to 8 weeks, Outcome 1 Participants complete cure.
84.2
84.2. Analysis
Comparison 84 Topical TCA 50% + local heat versus ILMA twice a week for up to 8 weeks, Outcome 2 Lesions cured.
85.1
85.1. Analysis
Comparison 85 TCA + ILMA (weekly for up to 8 weeks) versus ILMA alone (twice a week for up to 8 weeks), Outcome 1 Participants complete cure.
85.2
85.2. Analysis
Comparison 85 TCA + ILMA (weekly for up to 8 weeks) versus ILMA alone (twice a week for up to 8 weeks), Outcome 2 Speed of healing (weeks).
86.1
86.1. Analysis
Comparison 86 Fractional laser + ILMA (fortnightly 2 sessions) versus ILMA alone (twice a week for up to 8 weeks), Outcome 1 Participants complete cure.
87.1
87.1. Analysis
Comparison 87 TCA + ILMA (weekly for up to 8 weeks) versus fractional laser + ILMA (fortnightly 2 sessions), Outcome 1 Participants complete cure.
87.2
87.2. Analysis
Comparison 87 TCA + ILMA (weekly for up to 8 weeks) versus fractional laser + ILMA (fortnightly 2 sessions), Outcome 2 Speed of healing (weeks).
88.1
88.1. Analysis
Comparison 88 TCA fortnightly up to 8 weeks + ILMA (twice a week) versus ILMA alone (weekly for up to 8 weeks), Outcome 1 Participants complete cure.
89.1
89.1. Analysis
Comparison 89 Cryotherapy + ILMA (weekly) versus cryotherapy (weekly) for up to 6 weeks, Outcome 1 Participants complete cure.
89.2
89.2. Analysis
Comparison 89 Cryotherapy + ILMA (weekly) versus cryotherapy (weekly) for up to 6 weeks, Outcome 2 Adverse effects.
90.1
90.1. Analysis
Comparison 90 Cryotherapy + ILMA (weekly) versus ILMA (weekly) for up to 6 weeks, Outcome 1 Participants complete cure.
90.2
90.2. Analysis
Comparison 90 Cryotherapy + ILMA (weekly) versus ILMA (weekly) for up to 6 weeks, Outcome 2 Adverse effects.
91.1
91.1. Analysis
Comparison 91 Cryotherapy + ILMA (weekly) versus ILMA alone (weekly) for up to 6 weeks, Outcome 1 Participants complete cure.
91.2
91.2. Analysis
Comparison 91 Cryotherapy + ILMA (weekly) versus ILMA alone (weekly) for up to 6 weeks, Outcome 2 Adverse effects.
92.1
92.1. Analysis
Comparison 92 Cryotherapy (weekly) versus ILMA (weekly) for up to 6 weeks, Outcome 1 Participants complete cure.
93.1
93.1. Analysis
Comparison 93 Cryotherapy + ILMA (weekly) versus cryotherapy alone (weekly) for up to 6 weeks, Outcome 1 Lesions cured.
93.2
93.2. Analysis
Comparison 93 Cryotherapy + ILMA (weekly) versus cryotherapy alone (weekly) for up to 6 weeks, Outcome 2 Adverse effects.
94.1
94.1. Analysis
Comparison 94 Cryotherapy + ILMA (weekly) versus ILMA (fortnightly) for up to 6 weeks, Outcome 1 Lesions cured.
94.2
94.2. Analysis
Comparison 94 Cryotherapy + ILMA (weekly) versus ILMA (fortnightly) for up to 6 weeks, Outcome 2 Adverse effects.
95.1
95.1. Analysis
Comparison 95 Cryotherapy alone (weekly) versus ILMA (fortnightly) for up to 6 weeks, Outcome 1 Lesions cured.
95.2
95.2. Analysis
Comparison 95 Cryotherapy alone (weekly) versus ILMA (fortnightly) for up to 6 weeks, Outcome 2 Adverse effects.
96.1
96.1. Analysis
Comparison 96 Cryotherapy (fortnightly) + 15% paromomycin + 10% urea cream (twice a day) + ILMA (twice a day for 4 weeks) versus ILMA (twice a week) for up to 6 weeks, Outcome 1 Participants complete cure.
97.1
97.1. Analysis
Comparison 97 Cryotherapy (weekly) + 3% salicylic + 3% sodium nitrite cream (twice a day) for up to 12 weeks versus cryotherapy (weekly) + 3% salicylic cream (twice a day), Outcome 1 Lesions cured.
97.2
97.2. Analysis
Comparison 97 Cryotherapy (weekly) + 3% salicylic + 3% sodium nitrite cream (twice a day) for up to 12 weeks versus cryotherapy (weekly) + 3% salicylic cream (twice a day), Outcome 2 Adverse effects.
98.1
98.1. Analysis
Comparison 98 Radiofrequency waves versus ILMA (1 mL to 7 mL per lesion) weekly for 4 weeks, Outcome 1 Lesions cured.
98.2
98.2. Analysis
Comparison 98 Radiofrequency waves versus ILMA (1 mL to 7 mL per lesion) weekly for 4 weeks, Outcome 2 Participants complete cure.
98.3
98.3. Analysis
Comparison 98 Radiofrequency waves versus ILMA (1 mL to 7 mL per lesion) weekly for 4 weeks, Outcome 3 Adverse effects.
99.1
99.1. Analysis
Comparison 99 Radiofrequency waves (50 uCTM applied for 30 s) versus ILSSG (10 days of 20 mg/kg/d), Outcome 1 Lesions cured.
99.2
99.2. Analysis
Comparison 99 Radiofrequency waves (50 uCTM applied for 30 s) versus ILSSG (10 days of 20 mg/kg/d), Outcome 2 Adverse effects (serious).
100.1
100.1. Analysis
Comparison 100 Radiofrequency waves (1 treatment of > 1 consecutive application at 50ºC for 30 s) versus IMSSG (20 mg/kg/d for 3 weeks), Outcome 1 Participants complete cure.
100.2
100.2. Analysis
Comparison 100 Radiofrequency waves (1 treatment of > 1 consecutive application at 50ºC for 30 s) versus IMSSG (20 mg/kg/d for 3 weeks), Outcome 2 Adverse event (secondary infection).
101.1
101.1. Analysis
Comparison 101 Radiofrequency waves (1 treatment of > 1 consecutive application at 50ºC for 30 s) versus ILSSG (5 injections of 2 mL to 5 mL every 5 to 7 days), Outcome 1 Participants complete cure.
101.2
101.2. Analysis
Comparison 101 Radiofrequency waves (1 treatment of > 1 consecutive application at 50ºC for 30 s) versus ILSSG (5 injections of 2 mL to 5 mL every 5 to 7 days), Outcome 2 Adverse event (secondary infection).
102.1
102.1. Analysis
Comparison 102 Radiofrequency waves versus ILSSG, Outcome 1 Participants complete cure.
103.1
103.1. Analysis
Comparison 103 Electrocauterisation + DAC n‐055 (daily) versus electrocauterisation, Outcome 1 Adverse effects.
104.1
104.1. Analysis
Comparison 104 PDT (weekly for 4 weeks) versus placebo (twice a day for 4 weeks), Outcome 1 Lesions cured.
104.2
104.2. Analysis
Comparison 104 PDT (weekly for 4 weeks) versus placebo (twice a day for 4 weeks), Outcome 2 Scarring.
104.3
104.3. Analysis
Comparison 104 PDT (weekly for 4 weeks) versus placebo (twice a day for 4 weeks), Outcome 3 Microbiological cure of skin lesions.
105.1
105.1. Analysis
Comparison 105 Mesotherapy gun (0.5 mL of MA weekly) versus ILMA (0.1 mL weekly) for up to 6 weeks, Outcome 1 Participants complete cure.
105.2
105.2. Analysis
Comparison 105 Mesotherapy gun (0.5 mL of MA weekly) versus ILMA (0.1 mL weekly) for up to 6 weeks, Outcome 2 Adverse effects.
105.3
105.3. Analysis
Comparison 105 Mesotherapy gun (0.5 mL of MA weekly) versus ILMA (0.1 mL weekly) for up to 6 weeks, Outcome 3 Development of cell‐mediated immunity.
106.1
106.1. Analysis
Comparison 106 Diminazene aceturate solution (weekly) versus cetrimide + chlorhexidine solution for 50 d, Outcome 1 Participants complete cure.
107.1
107.1. Analysis
Comparison 107 Topical garlic (twice a day) versus vehicle for 3 weeks, Outcome 1 Participants complete cure.
108.1
108.1. Analysis
Comparison 108 Topical herbal extract + placebo (5 d) versus IMMA (15‐20/mg/kg/d) + vehicle for 20 d, Outcome 1 Participants complete cure.
109.1
109.1. Analysis
Comparison 109 Topical honey (twice a day) + ILMA (weekly) versus ILMA (weekly) for 4 weeks, Outcome 1 Participants complete cure.
110.1
110.1. Analysis
Comparison 110 Cassia fistula (topical gel) + ILMA (0.5 mL to 2 mL), twice a week versus ILMA (0.5 mL to 2 mL), twice a week + vehicle, Outcome 1 Participants complete cure.
110.2
110.2. Analysis
Comparison 110 Cassia fistula (topical gel) + ILMA (0.5 mL to 2 mL), twice a week versus ILMA (0.5 mL to 2 mL), twice a week + vehicle, Outcome 2 Adverse effects.
111.1
111.1. Analysis
Comparison 111 Cassia fistula boiled (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks, Outcome 1 Participants complete cure.
111.2
111.2. Analysis
Comparison 111 Cassia fistula boiled (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks, Outcome 2 Speed of healing (weeks).
111.3
111.3. Analysis
Comparison 111 Cassia fistula boiled (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks, Outcome 3 Adverse effects.
112.1
112.1. Analysis
Comparison 112 Cassia fistula hydroalcoholic (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks, Outcome 1 Participants complete cure.
112.2
112.2. Analysis
Comparison 112 Cassia fistula hydroalcoholic (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks, Outcome 2 Speed of healing (weeks).
112.3
112.3. Analysis
Comparison 112 Cassia fistula hydroalcoholic (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks, Outcome 3 Adverse reaction.
113.1
113.1. Analysis
Comparison 113 Cassia fistula boiled (topical) versusC fistula hydroalcoholic (topical) for 4 weeks, Outcome 1 Participants complete cure.
113.2
113.2. Analysis
Comparison 113 Cassia fistula boiled (topical) versusC fistula hydroalcoholic (topical) for 4 weeks, Outcome 2 Speed of healing (days).
113.3
113.3. Analysis
Comparison 113 Cassia fistula boiled (topical) versusC fistula hydroalcoholic (topical) for 4 weeks, Outcome 3 Adverse effects.
114.1
114.1. Analysis
Comparison 114 Topical gel Achilles millefollium (twice daily) + ILMA (weekly 20 mg/kg/d) versus ILMA (weekly 20 mg/kg/d) + vehicle (twice daily) for 4 weeks, Outcome 1 Participants complete cure.
114.2
114.2. Analysis
Comparison 114 Topical gel Achilles millefollium (twice daily) + ILMA (weekly 20 mg/kg/d) versus ILMA (weekly 20 mg/kg/d) + vehicle (twice daily) for 4 weeks, Outcome 2 Adverse effects.
114.3
114.3. Analysis
Comparison 114 Topical gel Achilles millefollium (twice daily) + ILMA (weekly 20 mg/kg/d) versus ILMA (weekly 20 mg/kg/d) + vehicle (twice daily) for 4 weeks, Outcome 3 Microbiological cure of skin lesions.
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References

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    1. Firooz A, Khamesipour A, Ghoorchi MH, Nassiri‐Kashani M, Eskandari SE, Khatami A, et al. Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: a randomized assessor‐blind controlled trial. Archives of Dermatology 2006;142(12):1575‐9. [PUBMED: 17178983 ] - PubMed
Gholami 2000 {published data only}
    1. Gholami A, Khamesipour A, Momeni A, Ghazanfari T, Nilforoushzadeh MA, Darajeh Z, et al. Treatment of cutaneous leishmaniasis with 5% garlic cream: a randomized, double‐blind study. Iranian Journal of Dermatology 2000;3(3):2‐6. [CENTRAL: CN‐00454251]
Harms 1991 {published data only}
    1. Harms G, Chehade AK, Douba M, Roepke M, Mouakeh A, Rosenkaimer F, et al. A randomized trial comparing a pentavalent antimonial drug and recombinant interferon‐gamma in the local treatment of cutaneous leishmaniasis. Transactions of the Royal Society of Tropical Medicine and Hygiene 1991;85(2):214‐6. [PUBMED: 1909469] - PubMed
Iraji 2004 {published data only}
    1. Iraji F, Vali A, Asilian A, Shahtalebi M, Momeni AZ. Comparison of intralesionally injected zinc sulphate with meglumine antimoniate in the treatment of acute cutaneous leishmaniasis. Dermatology 2004;209(1):46‐9. [PUBMED: 15237267] - PubMed
Iraji 2005 {published data only}
    1. Iraji F, Sadeghinia A. Efficacy of paromomycin ointment in the treatment of cutaneous leishmaniasis: results of a double‐blind, randomized trial in Isfahan, Iran. Annals of Tropical Medicine and Parasitology 2005;99(1):3‐9. [PUBMED: 15701249] - PubMed
Jaffar 2006 {published data only}
    1. Jaffar H. Rifampicin in cutaneous leishmaniasis ‐ a therapeutic trial in Saudi Arabia. Journal of Pakistan Association of Dermatologists 2006;16(1):4‐9. [EMBASE: 44265597]
Jaffary 2010 {published data only}
    1. Jaffary F, Nilforoushzadeh MA, Ansari N, Rahimi M. Treatment of cutaneous leishmaniasis: cassia fistula fruit gel‐intralesional glucantime Vs. placebo gel‐ intralesional glucantime combination. Tehran University Medical Journal 2010;67(10):705‐11.
Jaffary 2014a {published data only}
    1. Jaffary F, Nilforoushzadeh MA, Tavakoli N, Zolfaghari B, Shahbazi F. The efficacy of Achilles millefolium topical gel along with intralesional injection of glucantime in the treatment of acute cutaneous leishmaniasis major. Advanced Biomedical Research 2014;3:111. [PUBMED: 24804185 ] - PMC - PubMed
Jaffary 2014b {published data only}
    1. Jaffary F, Nilforoushzadeh MA, Moradi S, Derakhshan R, Ansari N. Concentrated extracts of Cassia fistula versus intralesional injection of meglumine antimoniate in treatment of acute cutaneous leishmaniasis. Journal of Skin and Stem Cell 2014;1(1):e16631. [EMBASE: 604236618]
Jebran 2014 {published data only}
    1. Jebran AF, Schleicher U, Steiner R, Wentker P, Mahfuz F, Stahl HC, et al. Rapid healing of cutaneous leishmaniasis by high‐frequency electrocauterization and hydrogel wound care with or without DAC N‐055: a randomized controlled phase IIa trial in Kabul. PLoS Neglected Tropical Diseases 2014;8(2):e2694. [PUBMED: 24551257 ] - PMC - PubMed
Jowkar 2012 {published data only}
    1. Jowkar F, Dehghani F, Jamshidzadeh A. Is topical nitric oxide and cryotherapy more effective than cryotherapy in the treatment of old world cutaneous leishmaniasis?. Journal of Dermatological Treatment 2012;23(2):131‐5. [PUBMED: 20964568 ] - PubMed
Kashani 2010 {published data only}
    1. Kashani MN, Sadr B, Nilforoushzadeh MA, Arasteh M, Babakoohi S, Firooz A. Treatment of acute cutaneous leishmaniasis with intralesional injection of meglumine antimoniate: comparison of conventional technique with mesotherapy gun. International Journal of Dermatology 2010;49(9):1034‐7. [PUBMED: 20883265 ] - PubMed
Khatami 2012 {published data only}
    1. Khatami A, Rahshenas M, Bahrami M, Ghoorchi MH, Eskandari SE, Sharifi I, et al. Miltefosine in treatment of cutaneous leishmaniasis: a randomized controlled trial (Poster P‐31). 6th International Dermato‐Epidemiology Association Congress, Malmo, Sweden, 26‐28 August 2012. British Journal of Dermatology 2012;167(2):e23. [EMBASE: 71050777]
Khatami 2013 {published data only}
    1. Khatami A, Talaee R, Rahshenas M, Khamesipour A, Mehryan P, Tehrani S, et al. Dressings combined with injection of meglumine antimoniate in the treatment of cutaneous leishmaniasis: a randomized controlled clinical trial. PloS One 2013;8(6):e66123. [PUBMED: 23826087] - PMC - PubMed
Kochar 2000 {published data only}
    1. Kochar DK, Aseri S, Sharma BV, Bumb RA, Mehta RD, Purohit SK. The role of rifampicin in the management of cutaneous leishmaniasis. QJM : Monthly Journal of the Association of Physicians 2000;93(11):733‐7. [PUBMED: 11077029] - PubMed
Kochar 2006 {published data only}
    1. Kochar DK, Saini G, Kochar SK, Sirohi P, Bumb RA, Mehta RD, et al. A double blind, randomised placebo controlled trial of rifampicin with omeprazole in the treatment of human cutaneous leishmaniasis. Journal of Vector Borne Diseases 2006;43(4):161‐7. [PUBMED: 17175700] - PubMed
Larbi 1995 {published data only}
    1. Larbi EB, al‐Khawajah A, al‐gindan Y, Jain S, Abahusain A, al‐Zayer A. A randomized, double‐blind, clinical trial of topical clotrimazole versus mizonazole for treatment of cutaneous leishmaniasis in the eastern province of Saudi Arabia. American Journal of Tropical Medicine and Hygiene 1995;52(2):166‐8. [PUBMED: 7872446] - PubMed
Layegh 2007 {published data only}
    1. Layegh P, Yazdanpanah MJ, Vosugh EM, Pezeshkpoor F, Shakeri MT, Moghiman T. Efficacy of azitromycin versus systemic meglumine antimoniate (Glucantime) in the treatment of cutaneous leishmaniasis. American Journal of Tropical Medicine and Hygiene 2007;77(1):99‐101. [PUBMED: 17620637] - PubMed
Layegh 2009 {published data only}
    1. Layegh P, Pezeshkpoor F, Soruri AH, Naviafar P, Moghiman T. Efficacy of cryotherapy versus intralesional meglumine antimoniate (Glucantime) for treatment of cutaneous leishmaniasis in children. American Journal of Tropical Medicine and Hygiene 2010;80(2):172‐5. [PUBMED: 19190206] - PubMed
Layegh 2011 {published data only}
    1. Layegh P, Rajabi O, Jafari MR, Emamgholi Tabar Malekshah P, Moghiman T, Ashraf H, et al. Efficacy of topical liposomal amphotericin B versus intralesional meglumine antimoniate (Glucantime) in the treatment of cutaneous leishmaniasis. Journal of Parasitology Research 2011;2011:656523. [DOI: 10.1155/2011/656523; PUBMED: 22174993 ] - DOI - PMC - PubMed
Lynen 1992 {published data only}
    1. Lynen L, Damme W. Local application of diminazene aceturate: an effective treatment for cutaneous leishmaniasis?. Annales de la Société Belge de Médecine Tropicale 1992;72(1):13‐9. [PUBMED: 1567264] - PubMed
Maleki 2012 {published data only}
    1. Maleki M, Karimi G, Tafaghodi M, Raftari S, Nahidi Y. Comparison of intralesional two percent zinc sulfate and glucantime injection in treatment of acute cutaneous leishmaniasis. Indian Journal of Dermatology 2012;57(2):118‐22. [PUBMED: 22615508] - PMC - PubMed
Mapar 2010 {published data only}
    1. Mapar MA, Omidian M. Intralesional injections of metronidazole versus meglumine antimoniate for the treatment of cutaneous leishmaniasis. Jundishapur Journal of Microbiology 2010;3(2):79‐83. [EMBASE: 2010406291]
Mashood 2001 {published data only}
    1. Mashhood AA, Hussain K. Efficacy of allopurinol compared with pentostam in the treatment of old world cutaneous leishmaniasis. Journal of the College of Physicians and Surgeons‐‐Pakistan : JCPSP 2001;11(6):367‐70. [EMBASE: 2001264054]
Mohebali 2007 {published data only}
    1. Mohebali M, Fotouhi A, Hooshmand B, Zarei Z, Akhoundi B, Rahnema A, et al. Comparison of miltefosine and meglumine antimoniate for the treatment of zoonotic cutaneous leishmaniasis (ZCL) by a randomized clinical trial in Iran. Acta Tropica 2007;103(1):33‐40. [PUBMED: 17586452] - PubMed
Momeni 1996 {published data only}
    1. Momeni AZ, Jalayer T, Emamjomeh M, Bashardost N, Ghassemi RL, Meghdadi M, et al. Treatment of cutaneous leishmaniasis with itraconazole. Randomized doubl‐blind study. Archives of Dermatology 1996;132(7):784‐6. [PUBMED: 8678570] - PubMed
Momeni 2002 {published data only}
    1. Momeni AZ, Reiszadae MR, Aminjavaheri M. Treatment of cutaneous leishmaniasis with a combination of allopurinol and low‐dose meglumine antimoniate. International Journal of Dermatology 2002;41(7):441‐3. [PUBMED: 12121563] - PubMed
Momeni 2003 {published data only}
    1. Momeni AZ, Aminjavaheri M, Omidghaemi MR. Treatment of cutaneous leishmaniasis with ketoconazole cream. Journal of Dermatological Treatment 2003;14(1):26‐9. [PUBMED: 12745852] - PubMed
Mostafavi 2013 {published data only}
    1. Mostafavi SA, Shatalebi MA, Attar AM, Hejazi H, Mottaghinejad A, Fadaei R, et al. Preparation and evaluation of clinical effects of glucantime gel mask. Journal of Isfahan Medical School 2013;31(231):389‐99. [EMBASE: 2014593999]
Mujtaba 1999 {published data only}
    1. Mujtaba G, Khalid M. Weekly vs. fortnightly intralesional meglumine antimoniate in cutaneous leishmaniasis. International Journal of Dermatology 1999;38(8):607‐9. [PUBMED: 10487452] - PubMed
Nassiri‐Kashani 2005 {published data only}
    1. Nassiri‐Kashani M, Firooz A, Khamesipour A, Mojtahed F, Nilforoushzadeh M, Hejazi H, et al. A randomized, double‐blind, placebo‐controlled clinical trial of itraconazole in the treatment of cutaneous leishmaniasis. Journal of the European Academy of Dermatology and Venereology: JEADV 2005;19(1):80‐3. [PUBMED: 15649196] - PubMed
Nilforoushzadeh 2004 {published data only}
    1. Nilforoushzadeh MA. Efficacy of combined triple therapy (paromomycin ointment, cryotherapy and intralesional Glucantime) in comparison with intralesional Glucantime for treatment of acute cutaneous leishmaniasis. Iranian Journal of Dermatology 2004;3(7):136‐9.
Nilforoushzadeh 2006 {published data only}
    1. Nilforoushzadeh MA, Jaffary F, Reiszadeh MR. Comparative effect of topical trichloroacetic acid and intralesional meglumine antimoniate in the treatment of acute cutaneous leishmaniasis. International Journal of Pharmacology 2006;2(6):633‐6. [EMBASE: 2007084731]
    1. Nilforoushzadeh MA, Reiszadeh MR, Jafari F. Topical trichloroacetic acid compared with intralesional glucantime injection in the treatment of acute wet cutaneous leishmaniasis: An open clinical trial. Iranian Journal of Dermatology 2003;2(6):34‐9.
Nilforoushzadeh 2007 {published data only}
    1. Nilforoushzadeh MA, Jaffary F, Moradi S, Derakhshan R, Haftbaradaran E. Effect of topical honey application along with intralesional injection of glucantime in the treatment of cutanneous leishmaniasis. BMC Complementary and Alternative Medicine 2007;7:13. [PUBMED: 17466071] - PMC - PubMed
Nilforoushzadeh 2008 {published data only}
    1. Nilforoushzadeh MA, Jaffary F, Ansari N, Siadat AH, Nilforoushan Z, Firouz A. A comparative study between the efficacy of systemic meglumine antimoniate therapy with standard or low dose plus oral omeprazole in the treatment of cutaneous leishmaniasis. Journal of Vector Borne Diseases 2008;45(4):287‐91. [PUBMED: 19248655] - PubMed
Nilforoushzadeh 2012 {published data only}
    1. Nilforoushzadeh MA, Naeeni FF, Sattar N, Haftbaradaran E, Jaffary F, Askari G. The effect of intralesional meglumine antimoniate (Glucantime) versus a combination of topical trichloroacetic acid 50% and local heat therapy by non‐ablative radiofrequency on cutaneous leishmaniasis lesions. Journal of Research in Medical Sciences 2012;17(1 Suppl 1):S97‐S102. [EMBASE: 2013471627]
Nilforoushzadeh 2013 {published data only}
    1. Nilforoushzadeh MA, Siadat AH, Ansari N, Haftbaradaran E, Ahmadi E. A comparison between the effects of glucantime, topical trichloroacetic acid 50% plus glucantime, and fractional laser plus glucantime on cutaneous leishmaniasis lesions. Journal of Isfahan Medical School 2013;30(221):2450‐9. [EMBASE: 2013245548] - PMC - PubMed
Nilforoushzadeh 2014a {published data only}
    1. Nilforoushzadeh MA, Siadat AH, Haftbaradaran E, Minaravesh M. Comparative study of the efficacy of CO2 and fraxel lasers in treatment of cutaneous leishmaniasis scars. Journal of Isfahan Medical School 2014;31(269 SPEC.ISSUE):2277‐84. [EMBASE: 2014574591]
Nilforoushzadeh 2014b {published data only}
    1. Nilforoushzadeh MA, Jaffary F, Derakhsahan R, Haftbaradaran E. Comparison between intralesional meglumine antimoniate and combination of trichloroacetic acid 50% and intralesional meglumine antimoniate in the treatment of acute cutaneous leishmaniasis: a randomized clinical trial. Journal of Stem Cells 2014;1(1):e16633. [DOI: 10.5812/jssc.16633; EMBASE: 2015013267] - DOI
Özgöztasi 1997 {published data only}
    1. Özgöztasi O, Baydar I. A randomized clinical trial of topical paromomycin versus oral ketoconazole for treating cutaneous leishmaniasis in Turkey. International Journal of Dermatology 1997;36(1):61‐3. [EMBASE: 1997097334] - PubMed
Ranawaka 2010 {published data only}
    1. Ranawaka RR, Weerakoon HS. Randomized, double‐blind, comparative clinical trial on the efficacy and safety of intralesional sodium stibogluconate and intralesional 7% hypertonic sodium chloride against cutaneous leishmaniasis caused by L. donovani. Journal of Dermatological Treatment 2010;21(5):286‐93. [PUBMED: 20438389] - PubMed
Ranawaka 2015 {published data only}
    1. Ranawaka RR, Weerakoon HS, Silva SH. Randomized, double‐blind, controlled, comparative study on intralesional 10% and 15% hypertonic saline versus intralesional sodium stibogluconate in Leishmania donovani cutaneous leishmaniasis. International Journal of Dermatology 2015;54(5):555‐63. [PUBMED: 25600472] - PubMed
Reithinger 2005 {published data only}
    1. Reithinger R, Mohsen M, Wahid M, Bismullah M, Quinnell RJ, Davies CR, et al. Efficacy of thermotherapy to treat cutaneous leishmaniasis caused by Leishmania tropica in Kabul, Afghanistan: a randomized, controlled trial. Clinical Infectious Diseases 2005;40(8):1148‐55. [PUBMED: 15791515] - PubMed
Sadeghian 2006a {published data only}
    1. Sadeghian G, Nilforoushzadeh MA. Effect of combination therapy with systemic glucantime and pentoxifylline in the treatment of cutaneous leishmaniasis. International Journal of Dermatology 2006;45(7):819‐21. [PUBMED: 16863518] - PubMed
Sadeghian 2006b {published data only}
    1. Sadeghian G, Nilfroushzadeh MA, Siadat AH. A comparison between intralesional hypertonic sodium chloride solution and meglumine antimoniate in the treatment of cutaneous leishmaniasis. Egyptian Dermatology Online Journal 2;1:8.
Sadeghian 2007 {published data only}
    1. Sadeghian G, Nilfroushzadeh MA, Iraji F. Efficacy of local heat therapy by radiofrequency in the treatment of cutaneous leishmaniasis, compared with intralesional injection of meglumine antimoniate. Clinical and Experimental Dermatology 2007;32(4):371‐4. [PUBMED: 17376205] - PubMed
Safi 2012 {published data only}
    1. Safi N, Davis GD, Nadir M, Hamid H, Robert LL, Case AJ. Evaluation of thermotherapy for the treatment of cutaneous leishmaniasis in Kabul, Afghanistan: a randomized controlled trial. Military Medicine 2012;177(3):345‐351. [PUBMED: 22479925] - PubMed
Salmanpour 2001 {published data only}
    1. Salmanpour R, Handjani F, Nouhpisheh MK. Comparative study of the efficacy of oral ketoconazole with intra‐lesional meglumine antimoniate (Glucantime) for the treatment of cutaneous leishmaniasis. Journal of Dermatological Treatment 2001;12:159‐62. [PUBMED: 12243707 ] - PubMed
Salmanpour 2006 {published data only}
    1. Salmanpour R, Razmavar MR, Abtahi N. Comparison of intralesional meglumine antimoniate, cryotherapy and their combination in the treatment of cutaneous leishmaniasis. International Journal of Dermatology 2006;45(9):1115‐6. [PUBMED: 16961529] - PubMed
Shamsi Meymandi 2011 {published data only}
    1. Shamsi Meymandi S, Zandi S, Aghaie H, Heshmatkhah A. Efficacy of CO(2) laser for treatment of anthroponotic cutaneous leishmaniasis, compared with combination of cryotherapy and intralesional meglumine antimoniate. Journal of the European Academy of Dermatology and Venereology : JEADV 2011;25(5):587‐91. [PUBMED: 20666876] - PubMed
Shanehsaz 2015 {published data only}
    1. Shanehsaz SM, Ishkhanian S. A comparative study between the efficacy of oral cimetidine and low‐dose systemic meglumine antimoniate (MA) with a standard dose of systemic MA in the treatment of cutaneous leishmaniasis. International Jornal of Dermatology 2015;54(7):834‐8. [PUBMED: 26108265] - PubMed
    1. Shanehsaz SM, Ishkhanian S. Therapeutic and adverse effects of standarddose and low‐dose meglumine antimoniate during systemic treatment of Syrian cutaneous leishmaniasis patients. Journal of Pakistan Association of Dermatologists 2014;24(2):115‐121. [EMBASE: 2014549292]
Sharquie 1997 {published data only}
    1. Sharquie KE, Najim RA, Farjou IB. A compararive controlled trial of intralesionally‐ administered zinc sulphate, hypertonic sodium chloride and pentavalent antimony compound against cutaneous leishmaniasis. Clinical and Experimental Dermatology 1997;22(4):169‐73. [PUBMED: 9499605] - PubMed
Sharquie 2001 {published data only}
    1. Sharquie KE, Najim RA, Farjou IB, Al‐timimit DJ. Oral zinc sulphate in the treatment of acute cutaneous leishmaniasis. Clinical and Experimental Dermatology 2001;26(1):21‐6. [PUBMED: 11260171] - PubMed
Shazad 2005 {published data only}
    1. Shazad B, Abbaszadeh B, Khamesipour A. Comparison of topical paromomycin sulfate (twice/day) with intralesional meglumine antimoniate for the treatment of cutaneous leishmaniasis caused by L. major. European Journal of Dermatology 2005;15(2):85‐7. [PUBMED: 15757817] - PubMed
Stahl 2014 {published data only}
    1. Stahl HC, Ahmadi F, Schleicher U, Sauerborn R, Bermejo JL, Amirih ML, et al. A randomized controlled phase IIb wound healing trial of cutaneous leishmaniasis ulcers with 0.045% pharmaceutical chlorite (DAC N‐055) with and without bipolar high frequency electro‐cauterization versus intralesional antimony in Afghanistan. BMC Infectious Diseases 2014;14:619. [PUBMED: 25420793] - PMC - PubMed
Yazdanpanah 2011 {published data only}
    1. Yazdanpanah MJ, Banihashemi M, Pezeshkpoor F, Khajedaluee M, Famili S, Tavakoli Rodi I, et al. Comparison of oral zinc sulfate with systemic meglumine antimoniate in the treatment of cutaneous leishmaniasis. Dermatology Research & Practice 2011;269515:1‐4. [DOI: 10.1155/2011/269515; PUBMED: 21747837] - DOI - PMC - PubMed
Zerehsaz 1999 {published data only}
    1. Zerehsaz F, Salmanpour R, Farhad H, Ardehali S, Panjehshahin MR, Tabei SZ, et al. 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. International Journal of Dermatology 1999;38(8):610‐2. [PUBMED: 10487453] - PubMed

References to studies excluded from this review

Alavi‐Naini 2012 {published data only}
    1. Alavi‐Naini R, Fazaeli A, O'Dempsey T. Topical treatment modalities for old world cutaneous leishmaniasis: a review. Prague Medical Report 2012;113(2):105‐18. [PUBMED: 22691282] - PubMed
Banihashemi 2015 {published data only}
    1. Banihashemi M, Yazdanpanah MJ, Amirsolymani H, Yousefzadeh H. Comparison of lesion improvement in lupoid leishmaniasis patients with two treatment approaches: trichloroacetic Acid and intralesional meglumine antimoniate. Journal of Cutaneous Medicine and Surgery 2015;19(1):35‐9. [PUBMED: 25775661] - PubMed
Bumb 2010 {published data only}
    1. Bumb RA, Mehta RD, Ghiya BC, Jakhar R, Prasad N, Soni P, et al. Efficacy of short‐duration (twice weekly) intralesional sodium stibogluconate in treatment of cutaneous Leishmaniasis in India. British Journal of Dermatology 2010;163(4):854‐8. [PUBMED: 20500797] - PubMed
Dogra 1986 {published data only}
    1. Dogra J, Lal BB, Misra SN. Dapsone in the treatment of cutaneous leishmaniasis. International Journal of Dermatology 1986;25(6):398‐400. [PUBMED: 3531044] - PubMed
Dogra 1994 {published data only}
    1. Dogra J, Aneja N. Leishmaniasis and itraconazole: a controlled clinical trial on cutaneous subtypes. International Journal of Antimicrobial Agents 1994;4(4):309‐11. [PUBMED: 18611622] - PubMed
Dorlo 2012 {published data only}
    1. Dorlo TP, Balasegaram M, Beijnen JH, Vries PJ. Miltefosine: a review of its pharmacology and therapeutic efficacy in the treatment of leishmaniasis. Journal of Antimicrobial Chemotherapy 2012;67(11):2576‐97. [PUBMED: 22833634 ] - PubMed
El On 1992 {published data only}
    1. el‐On J, Halevy S, Grunwald MH, Weinrauch L. Topical treatment of Old World cutaneous leishmaniasis caused by Leishmania major: a double blind control study. Journal of the American Academy of Dermatology 1992;27(2 Pt 1):227‐31. [PUBMED: 1430361] - PubMed
Frankenburg 1993 {published data only}
    1. Frankenburg S, Gross A, Jonas F, Klaus S. Effect of topical paromomycin on cell‐mediated immunity during cutaneous leishmaniasis. International Journal of Dermatology 1993;32(1):68‐70. [PUBMED: 8425810] - PubMed
Kim 2009 {published data only}
    1. Kim DH, Chung HJ, Bleys J, Ghohestani RF. Is paromomycin an effective and safe treatment against cutaneous leishmaniasis? A meta‐analysis of 14 randomized controlled trials. PLoS Neglected Tropical Diseases 2009;3(2):e381. [PUBMED: 19221595] - PMC - PubMed
Moosavi 2005 {published data only}
    1. Moosavi Z, Nakhli A, Rassaii S. Comparing the efficiency of topical paromomycin with intralesional meglumine antimoniate for cutaneous leishmaniasis. International Journal of Dermatology 2005;44(12):1064‐5. [PUBMED: 16409282] - PubMed
Nilforoushzadeh 2010 {published data only}
    1. Ali NM, Fariba J, Elaheh H, Ali N. The efficacy of 5% trichoroacetic acid cream in the treatment of cutaneous leishmaniasis lesions. Journal of Dermatological Treatment 2012;23(2):136‐9. [PUBMED: 21034291] - PubMed
Nilforoushzadeh 2011 {published data only}
    1. Nilforoushzadeh MA, Jaffary F, Ansari N, Moradi S, Siadat AH. The comparison between trichloroacetic acid 50% and CO2 laser in the treatment of cutaneous leishmaniasis scar. Indian Journal of Dermatology 2011;56(2):171‐3. [PUBMED: 21716542] - PMC - PubMed
Siavash 2013 {published data only}
    1. Shanehsaz SM, Ishkhanian S. Electrocardiographic and biochemical adverse effects of meglumine antimoniate during the treatment of Syrian cutaneous leishmaniasis. Egyptian Dermatology Journal 2013;9(1):5.
Singh 1995 {published data only}
    1. Singh S, Singh R, Sundar S. Failure of ketaconazole in oriental sore in India. Journal of Chemotherapy 1995;7(4):202‐3. [PUBMED: 8904156] - PubMed
Trau 1987 {published data only}
    1. Trau H, Schewach‐Millet M, Shoham J, Doerner T, Shor R, Passwell JH. Topical application of human fibroblast interferon (IFN) in cutaneous leishmaniasis. Israel Journal of Medical Sciences 1987;23(11):1125‐7. [PUBMED: 3325468] - PubMed

References to studies awaiting assessment

Farajzadeh 2016a {published data only}
    1. Farajzadeh S, Hakimi Parizi M, Haghdoost AA, Mohebbi A, Mohammadi S, Pardakhty A, et al. Comparison between intralesional injection of zinc sulfate 2 % solution and intralesional meglumine antimoniate in the treatment of acute old world dry type cutaneous leishmaniasis: a randomized double‐blind clinical trial. Journal of Parasitic Diseases 2016;40(3):935‐9. [PUBMED: 27605813] - PMC - PubMed
Farajzadeh 2016b {published data only}
    1. Farajzadeh S, Heshmatkhah A, Vares B, Mohebbi E, Mohebbi A, Aflatoonian M, et al. Topical terbinafine in the treatment of cutaneous leishmaniasis: triple blind randomized clinical trial. Journal of Parasitic Diseases 2016;40(4):1159‐64. [DOI: 10.1007/s12639-014-0641-1; PUBMED: 27876906] - DOI - PMC - PubMed
Hanif 2016 {published data only}
    1. Hanif MM, Akram K, Mustafa G. Intralesional versus oral chloroquine in cutaneous leishmaniasis: comparison of outcome, duration of treatment and total dose of drug. Journal of the College of Physicians and Surgeons Pakistan 2016;26(4):260‐2. [PUBMED: 27097693] - PubMed
Jaffary 2016 {published data only}
    1. Jaffary F, Nilforoushzadeh MA, Siadat A, Haftbaradaran E, Ansari N, Ahmadi E. A comparison between the effects of Glucantime, topical trichloroacetic acid 50% plus Glucantime, and fractional carbon dioxide laser plus Glucantime on cutaneous leishmaniasis lesions. Dermatology Research and Practice 2016;2016:6462804. [PUBMED: 27148363] - PMC - PubMed
Na‐Bangchang 2016 {published data only}
    1. Na‐Bangchang K, Ahmed O, Hussein J, Hirayama K, Kongjam P, Aseffa A, et al. Exploratory, phase II controlled trial of shiunko ointment local application twice a day for 4 weeks in Ethiopian patients with localized cutaneous leishmaniasis. Evidence‐Based Complementary and Alternative Medicine 2016;2016:5984709. [PUBMED: 27195014] - PMC - PubMed
Rajabi 2016 {published data only}
    1. Rajabi O, Layegh P, Hashemzadeh S, Khoddami M. Topical liposomal azithromycin in the treatment of acute cutaneous leishmaniasis. Dermatologic Therapy 2016;29(5):358‐63. [DOI: 10.1111/dth.12357; PUBMED: 27073044] - DOI - PubMed
Refai 2016 {published and unpublished data}
    1. Refai W, Madarasingha N, Weerasingha S, Senarath U, Silva A, Fernandopulle R, et al. Efficacy, safety and cost‐effectiveness of thermotherapy for L. donovani‐induced cutaneous leishmaniasis: a randomized controlled clinical trial. International Journal of Infectious Diseases 2016;45:74. [CENTRAL: CN‐01142616]
Sattar 2012 {published data only}
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References to ongoing studies

ACTRN12614001288617 {unpublished data only}
    1. ACTRN12614001288617. A clinical trial to assess the safety and effect of heat therapy in comparison to standard intra‐lesional sodium stibogluconate for cutaneous leishmaniasis [In patients with cutaneous leishmaniasis, thermotherapy was compared with standard intra‐lesional therapy with regard to efficacy and safety]. anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614001288617 Date first received: 10 December 2014.
IRCT138904091159N7 {unpublished data only}
    1. IRCT138904091159N7. Comparison between two groups in the treatment of cutaneous leishmaniasis [Comparison between the efficacy of intralesional placebo and nitric oxide releasing patch versus placebo patch and glucantime in the treatment of cutaneous leishmaniasis]. www.irct.ir/searchresult.php?id=1159&number=7 Date first received: 2 September 2013.
IRCT2013092414746N1 {unpublished data only}
    1. IRCT2013092414746N1. Treatment of patients with ZCL [The effect of MJ1 (Topical dairy extract) versus routine care for treatment of cutaneous leishmaniasis (rural) in Isfahan Iran :a randomized controled clinical trial (RCTs) ‐]. apps.who.int/trialsearch/Trial2.aspx?TrialID=IRCT2013092414746N1 Date first received: 20 February 2014.
NCT00840359 {unpublished data only}
    1. NCT00840359. Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis [Phase 2 Study of the Efficacy of Daylight Activated Photodynamic Therapy in the Treatment of Cutaneous Leishmaniasis]. clinicaltrials.gov/ct2/show/NCT00840359 Date first received: 8 February 2009.
NCT01050777 {unpublished data only}
    1. NCT01050777. Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis [Pilot Study of Efficacy of Topical Nano‐liposomal Meglumine Antimoniate (Glucantime) or Paromomycin in Combination With Systemic Glucantime for the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL) Caused by Leishmania Tropica]. clinicaltrials.gov/ct2/show/NCT01050777 Date first received: 13 January 2010.
SLCTR/2014/028 {unpublished data only}
    1. SLCTR/2014/028. Treatment for leishmaniasis [Randomized, double blind, controlled study on efficacy and safety of intralesional metronidazole vs intralesional sodium stibogluconate in L. donovani cutaneous leishmaniasis]. slctr.lk/trials/276 Date first received: 18 October 2014.

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