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Meta-Analysis
. 2020 Aug 27;8(8):CD004834.
doi: 10.1002/14651858.CD004834.pub3.

Interventions for American cutaneous and mucocutaneous leishmaniasis

Mariona Pinart  1 , José-Ramón Rueda  2 , Gustavo As Romero  3 , Carlos Eduardo Pinzón-Flórez  4 , Karime Osorio-Arango  5 , Ana Nilce Silveira Maia-Elkhoury  6 , Ludovic Reveiz  7 , Vanessa M Elias  7 , John A Tweed  8
Affiliations
Meta-Analysis

Interventions for American cutaneous and mucocutaneous leishmaniasis

Mariona Pinart et al. Cochrane Database Syst Rev. .

Abstract

Background: On the American continent, cutaneous and mucocutaneous leishmaniasis (CL and MCL) are diseases associated with infection by several species of Leishmania parasites. Pentavalent antimonials remain the first-choice treatment. There are alternative interventions, but reviewing their effectiveness and safety is important as availability is limited. This is an update of a Cochrane Review first published in 2009.

Objectives: To assess the effects of interventions for all immuno-competent people who have American cutaneous and mucocutaneous leishmaniasis (ACML).

Search methods: We updated our database searches of the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, LILACS and CINAHL to August 2019. We searched five trials registers.

Selection criteria: Randomised controlled trials (RCTs) assessing either single or combination treatments for ACML in immuno-competent people, diagnosed by clinical presentation and Leishmania infection confirmed by smear, culture, histology, or polymerase chain reaction on a biopsy specimen. The comparators were either no treatment, placebo only, or another active compound.

Data collection and analysis: We used standard methodological procedures expected by Cochrane. Our key outcomes were the percentage of participants 'cured' at least three months after the end of treatment, adverse effects, and recurrence. We used GRADE to assess evidence certainty for each outcome.

Main results: We included 75 studies (37 were new), totalling 6533 randomised participants with ATL. The studies were mainly conducted in Central and South America at regional hospitals, local healthcare clinics, and research centres. More male participants were included (mean age: roughly 28.9 years (SD: 7.0)). The most common confirmed species were L. braziliensis, L. panamensis, and L. mexicana. The most assessed interventions and comparators were non-antimonial systemics (particularly oral miltefosine) and antimonials (particularly meglumine antimoniate (MA), which was also a common intervention), respectively. Three studies included moderate-to-severe cases of mucosal leishmaniasis but none included cases with diffuse cutaneous or disseminated CL, considered the severe cutaneous form. Lesions were mainly ulcerative and located in the extremities and limbs. The follow-up (FU) period ranged from 28 days to 7 years. All studies had high or unclear risk of bias in at least one domain (especially performance bias). None of the studies reported the degree of functional or aesthetic impairment, scarring, or quality of life. Compared to placebo, at one-year FU, intramuscular (IM) MA given for 20 days to treat L. braziliensis and L. panamensis infections in ACML may increase the likelihood of complete cure (risk ratio (RR) 4.23, 95% confidence interval (CI) 0.84 to 21.38; 2 RCTs, 157 participants; moderate-certainty evidence), but may also make little to no difference, since the 95% CI includes the possibility of both increased and reduced healing (cure rates), and IMMA probably increases severe adverse effects such as myalgias and arthralgias (RR 1.51, 95% CI 1.17 to 1.96; 1 RCT, 134 participants; moderate-certainty evidence). IMMA may make little to no difference to the recurrence risk, but the 95% CI includes the possibility of both increased and reduced risk (RR 1.79, 95% CI 0.17 to 19.26; 1 RCT, 127 participants; low-certainty evidence). Compared to placebo, at six-month FU, oral miltefosine given for 28 days to treat L. mexicana, L. panamensis and L. braziliensis infections in American cutaneous leishmaniasis (ACL) probably improves the likelihood of complete cure (RR 2.25, 95% CI 1.42 to 3.38), and probably increases nausea rates (RR 3.96, 95% CI 1.49 to 10.48) and vomiting (RR 6.92, 95% CI 2.68 to 17.86) (moderate-certainty evidence). Oral miltefosine may make little to no difference to the recurrence risk (RR 2.97, 95% CI 0.37 to 23.89; low-certainty evidence), but the 95% CI includes the possibility of both increased and reduced risk (all based on 1 RCT, 133 participants). Compared to IMMA, at 6 to 12 months FU, oral miltefosine given for 28 days to treat L. braziliensis, L. panamensis, L. guyanensis and L. amazonensis infections in ACML may make little to no difference to the likelihood of complete cure (RR 1.05, 95% CI 0.90 to 1.23; 7 RCTs, 676 participants; low-certainty evidence). Based on moderate-certainty evidence (3 RCTs, 464 participants), miltefosine probably increases nausea rates (RR 2.45, 95% CI 1.72 to 3.49) and vomiting (RR 4.76, 95% CI 1.82 to 12.46) compared to IMMA. Recurrence risk was not reported. For the rest of the key comparisons, recurrence risk was not reported, and risk of adverse events could not be estimated. Compared to IMMA, at 6 to 12 months FU, oral azithromycin given for 20 to 28 days to treat L. braziliensis infections in ACML probably reduces the likelihood of complete cure (RR 0.51, 95% CI 0.34 to 0.76; 2 RCTs, 93 participants; moderate-certainty evidence). Compared to intravenous MA (IVMA) and placebo, at 12 month FU, adding topical imiquimod to IVMA, given for 20 days to treat L. braziliensis, L. guyanensis and L. peruviana infections in ACL probably makes little to no difference to the likelihood of complete cure (RR 1.30, 95% CI 0.95 to 1.80; 1 RCT, 80 participants; moderate-certainty evidence). Compared to MA, at 6 months FU, one session of local thermotherapy to treat L. panamensis and L. braziliensis infections in ACL reduces the likelihood of complete cure (RR 0.80, 95% CI 0.68 to 0.95; 1 RCT, 292 participants; high-certainty evidence). Compared to IMMA and placebo, at 26 weeks FU, adding oral pentoxifylline to IMMA to treat CL (species not stated) probably makes little to no difference to the likelihood of complete cure (RR 0.86, 95% CI 0.63 to 1.18; 1 RCT, 70 participants; moderate-certainty evidence).

Authors' conclusions: Evidence certainty was mostly moderate or low, due to methodological shortcomings, which precluded conclusive results. Overall, both IMMA and oral miltefosine probably result in an increase in cure rates, and nausea and vomiting are probably more common with miltefosine than with IMMA. Future trials should investigate interventions for mucosal leishmaniasis and evaluate recurrence rates of cutaneous leishmaniasis and its progression to mucosal disease.

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Conflict of interest statement

Mariona Pinart: none known. José‐Ramón Rueda: none known. Gustavo AS Romero: author on included study Toledo 2014 but not involved in data extraction or assessment of risks of bias. Carlos Eduardo Pinzón‐Flórez: none known. Luz Karime Osorio Arango: none known. Ana Nilce Silveira Maia‐Elkhoury: 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. Vanessa M Elias: none known. John A Tweed: none known

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
1.1
1.1. Analysis
Comparison 1: IM Meglumine Antimoniate (20 mg/kg/d for 20 d) vs placebo (3 tablets/4 times a day for 28 d) in L. braziliensis and L. panamensis; FU: 3 months and 1 year, Outcome 1: Complete cure
1.2
1.2. Analysis
Comparison 1: IM Meglumine Antimoniate (20 mg/kg/d for 20 d) vs placebo (3 tablets/4 times a day for 28 d) in L. braziliensis and L. panamensis; FU: 3 months and 1 year, Outcome 2: Adverse effects (FU one year)
1.3
1.3. Analysis
Comparison 1: IM Meglumine Antimoniate (20 mg/kg/d for 20 d) vs placebo (3 tablets/4 times a day for 28 d) in L. braziliensis and L. panamensis; FU: 3 months and 1 year, Outcome 3: Recurrence (FU one year)
2.1
2.1. Analysis
Comparison 2: 10‐day IM Meglumine Antimoniate 20 mg/Kg/day vs 20‐day IM Meglumine Antimoniate in L. braziliensis and L. panamensis; FU: 1 year, Outcome 1: Complete cure
2.2
2.2. Analysis
Comparison 2: 10‐day IM Meglumine Antimoniate 20 mg/Kg/day vs 20‐day IM Meglumine Antimoniate in L. braziliensis and L. panamensis; FU: 1 year, Outcome 2: Complete cure in children
2.3
2.3. Analysis
Comparison 2: 10‐day IM Meglumine Antimoniate 20 mg/Kg/day vs 20‐day IM Meglumine Antimoniate in L. braziliensis and L. panamensis; FU: 1 year, Outcome 3: Adverse effects
3.1
3.1. Analysis
Comparison 3: IV Meglumine Antimoniate 20 mg/kg/d for 15 d vs no treatment in L. panamensis; FU: 12 months, Outcome 1: Complete cure
3.2
3.2. Analysis
Comparison 3: IV Meglumine Antimoniate 20 mg/kg/d for 15 d vs no treatment in L. panamensis; FU: 12 months, Outcome 2: Recurrence
4.1
4.1. Analysis
Comparison 4: IV Meglumine Antimoniate for 7 days + placebo topically TD for 10 d vs IV Meglumine Antimoniate for 20 d in L. braziliensis & L. panamensis; FU: 1 year, Outcome 1: Complete cure
5.1
5.1. Analysis
Comparison 5: IV Meglumine Antimoniate 15% (14 mg/kg/d) vs IV Meglumine Antimoniate 30% (28 mg/kg/d) ; FU: 2 years, Outcome 1: Complete cure (CL plus MCL)
5.2
5.2. Analysis
Comparison 5: IV Meglumine Antimoniate 15% (14 mg/kg/d) vs IV Meglumine Antimoniate 30% (28 mg/kg/d) ; FU: 2 years, Outcome 2: Complete cure CL form
5.3
5.3. Analysis
Comparison 5: IV Meglumine Antimoniate 15% (14 mg/kg/d) vs IV Meglumine Antimoniate 30% (28 mg/kg/d) ; FU: 2 years, Outcome 3: Complete cure MCL form
6.1
6.1. Analysis
Comparison 6: Meglumine Antimoniate low dosage (5mg/kg/day) (30 to 120 days) up to vs high dosage (20‐30 mg+/kg/day) (20‐30 days) in L. braziliensis; FU: 12‐45 months, Outcome 1: Complete cure
6.2
6.2. Analysis
Comparison 6: Meglumine Antimoniate low dosage (5mg/kg/day) (30 to 120 days) up to vs high dosage (20‐30 mg+/kg/day) (20‐30 days) in L. braziliensis; FU: 12‐45 months, Outcome 2: Adverse effects
7.1
7.1. Analysis
Comparison 7: 10‐day IV Meglumine Antimoniate 20mg/kg/day + 10‐day placebo versus 20‐day IV Meglumine Antimoniate in L. braziliensis and L. mexicana; FU: 1 year, Outcome 1: Complete cure
7.2
7.2. Analysis
Comparison 7: 10‐day IV Meglumine Antimoniate 20mg/kg/day + 10‐day placebo versus 20‐day IV Meglumine Antimoniate in L. braziliensis and L. mexicana; FU: 1 year, Outcome 2: Adverse effects: arthralgia
8.1
8.1. Analysis
Comparison 8: Intralesional antimony (650 μg/mm2) vs placebo in L. braziliensis,L. amazonensis,L. guyanensis and L. lainsoni; FU: 6 months, Outcome 1: Complete cure
9.1
9.1. Analysis
Comparison 9: Meglumine antimoniate 20 mg/kg/day plus oral tamoxifen 40 mg/day versus meglumine antimoniate alone in L. braziliensis; FU: 3‐6 months, Outcome 1: Complete cure at 3‐6 months
9.2
9.2. Analysis
Comparison 9: Meglumine antimoniate 20 mg/kg/day plus oral tamoxifen 40 mg/day versus meglumine antimoniate alone in L. braziliensis; FU: 3‐6 months, Outcome 2: Recurrence at 6 months
10.1
10.1. Analysis
Comparison 10: Meglumine antimoniate 20 mg/kg/day plus topical tamoxifen for 20 days (0.1% citrate) versus meglumine antimoniate alone in L. braziliensis; FU: 3‐6 months, Outcome 1: Complete cure at 3‐6 months
10.2
10.2. Analysis
Comparison 10: Meglumine antimoniate 20 mg/kg/day plus topical tamoxifen for 20 days (0.1% citrate) versus meglumine antimoniate alone in L. braziliensis; FU: 3‐6 months, Outcome 2: Recurrence at 6 months
11.1
11.1. Analysis
Comparison 11: IV meglumine antimoniate (IVMA) plus antihelminthic treatment versus IVMA plus placebo in L.braziliensis; FU: 90 days, Outcome 1: Complete cure
12.1
12.1. Analysis
Comparison 12: IM Sodium Stibogluconate 20 mg/kg/d for 20d vs IM Meglumine Antimoniate (20 mg/kg/d for 20d) in L. panamensis; FU: 6 months, Outcome 1: Complete cure
12.2
12.2. Analysis
Comparison 12: IM Sodium Stibogluconate 20 mg/kg/d for 20d vs IM Meglumine Antimoniate (20 mg/kg/d for 20d) in L. panamensis; FU: 6 months, Outcome 2: Adverse effect Overall
12.3
12.3. Analysis
Comparison 12: IM Sodium Stibogluconate 20 mg/kg/d for 20d vs IM Meglumine Antimoniate (20 mg/kg/d for 20d) in L. panamensis; FU: 6 months, Outcome 3: Adverse effects
12.4
12.4. Analysis
Comparison 12: IM Sodium Stibogluconate 20 mg/kg/d for 20d vs IM Meglumine Antimoniate (20 mg/kg/d for 20d) in L. panamensis; FU: 6 months, Outcome 4: Recurrence
12.5
12.5. Analysis
Comparison 12: IM Sodium Stibogluconate 20 mg/kg/d for 20d vs IM Meglumine Antimoniate (20 mg/kg/d for 20d) in L. panamensis; FU: 6 months, Outcome 5: Microbiological or histopathological cure of skin lesions
13.1
13.1. Analysis
Comparison 13: IM Sodium Stibogluconate (branded) vs IM Sodium Stibogluconate (generic). Dose: 20 mg/kg/d for 20 d in L.panamensis; FU: 6 months, Outcome 1: Complete cure
13.2
13.2. Analysis
Comparison 13: IM Sodium Stibogluconate (branded) vs IM Sodium Stibogluconate (generic). Dose: 20 mg/kg/d for 20 d in L.panamensis; FU: 6 months, Outcome 2: Adverse effects
14.1
14.1. Analysis
Comparison 14: Low dose of IV sodium stibogluconate 20 days versus high doses in L.panamensis and L. chagasi; FU: 1 year, Outcome 1: Adverse effects
15.1
15.1. Analysis
Comparison 15: IV Sodium Stibogluconate 20mg/kg for 28 days vs IV Sodium Stibogluconate for 40 days in L. braziliensis; FU: 1 year, Outcome 1: Complete cure
16.1
16.1. Analysis
Comparison 16: IL Sodium Stibogluconate (650 μg; Sb 8 μL/mm2) vs IL pentamidine (240 μg; 8 μL/mm2) in L. braziliensis and L. braziliensis/amazonensis/lainsoni/guyanensis; FU: 6 months, Outcome 1: Complete cure
16.2
16.2. Analysis
Comparison 16: IL Sodium Stibogluconate (650 μg; Sb 8 μL/mm2) vs IL pentamidine (240 μg; 8 μL/mm2) in L. braziliensis and L. braziliensis/amazonensis/lainsoni/guyanensis; FU: 6 months, Outcome 2: Adverse effects
16.3
16.3. Analysis
Comparison 16: IL Sodium Stibogluconate (650 μg; Sb 8 μL/mm2) vs IL pentamidine (240 μg; 8 μL/mm2) in L. braziliensis and L. braziliensis/amazonensis/lainsoni/guyanensis; FU: 6 months, Outcome 3: Recurrence
17.1
17.1. Analysis
Comparison 17: Oral ketoconazole 200 mg for 28 days vs IM Meglumine Antimoniate 20 mg/kg for 20 days in L. panamensis and L. mexicana; FU: 3 months, Outcome 1: Complete cure
17.2
17.2. Analysis
Comparison 17: Oral ketoconazole 200 mg for 28 days vs IM Meglumine Antimoniate 20 mg/kg for 20 days in L. panamensis and L. mexicana; FU: 3 months, Outcome 2: Adverse effects
17.3
17.3. Analysis
Comparison 17: Oral ketoconazole 200 mg for 28 days vs IM Meglumine Antimoniate 20 mg/kg for 20 days in L. panamensis and L. mexicana; FU: 3 months, Outcome 3: Speed to healing (% of complete re‐epithelization of lesions at 1 month in cured patients)
17.4
17.4. Analysis
Comparison 17: Oral ketoconazole 200 mg for 28 days vs IM Meglumine Antimoniate 20 mg/kg for 20 days in L. panamensis and L. mexicana; FU: 3 months, Outcome 4: Miocrobiological cure of skin lesions (% in cured patients)
18.1
18.1. Analysis
Comparison 18: Oral ketoconazole 200 mg vs oral placebo for 28 days in L. panamensis and L. mexicana; FU: 3 months, Outcome 1: Complete cure
19.1
19.1. Analysis
Comparison 19: 300‐450 mg oral Fluconazole vs 20mg/kg/d IV Meglumine Antimoniate 20 mg/kg in L. braziliensis; FU: 3‐6 months, Outcome 1: Complete cure
19.2
19.2. Analysis
Comparison 19: 300‐450 mg oral Fluconazole vs 20mg/kg/d IV Meglumine Antimoniate 20 mg/kg in L. braziliensis; FU: 3‐6 months, Outcome 2: Adverse effects
19.3
19.3. Analysis
Comparison 19: 300‐450 mg oral Fluconazole vs 20mg/kg/d IV Meglumine Antimoniate 20 mg/kg in L. braziliensis; FU: 3‐6 months, Outcome 3: Needed rescue therapy
19.4
19.4. Analysis
Comparison 19: 300‐450 mg oral Fluconazole vs 20mg/kg/d IV Meglumine Antimoniate 20 mg/kg in L. braziliensis; FU: 3‐6 months, Outcome 4: Speed to healing (days)
20.1
20.1. Analysis
Comparison 20: Oral Allopurinol 20 mg/kg/d (4 doses) for 15d vs Allopurinol + IM Meglumine Antimoniate 20 mg/kg (same regimen) in L. panamensis; FU: 12 months, Outcome 1: Complete cure
20.2
20.2. Analysis
Comparison 20: Oral Allopurinol 20 mg/kg/d (4 doses) for 15d vs Allopurinol + IM Meglumine Antimoniate 20 mg/kg (same regimen) in L. panamensis; FU: 12 months, Outcome 2: Recurrence
21.1
21.1. Analysis
Comparison 21: Oral Allopurinol 20 mg/kg/d (4 doses) x 15d vs. IV Meglumine Antimoniate (same regimen) in L. panamensis; FU: 1 year, Outcome 1: Complete cure
21.2
21.2. Analysis
Comparison 21: Oral Allopurinol 20 mg/kg/d (4 doses) x 15d vs. IV Meglumine Antimoniate (same regimen) in L. panamensis; FU: 1 year, Outcome 2: Recurrence
22.1
22.1. Analysis
Comparison 22: Oral Allopurinol 20 mg/kg/d + IV Meglumine Antimoniate (20 mg/kg/d (4 doses) for 15d) vs IV Meglumine Antimoniate (same regimen) in L. panamensis; FU: 1 year, Outcome 1: Complete cure
22.2
22.2. Analysis
Comparison 22: Oral Allopurinol 20 mg/kg/d + IV Meglumine Antimoniate (20 mg/kg/d (4 doses) for 15d) vs IV Meglumine Antimoniate (same regimen) in L. panamensis; FU: 1 year, Outcome 2: Recurrence
23.1
23.1. Analysis
Comparison 23: Oral Allopurinol 300 mg for 28d vs IM Meglumine Antimoniate 20mg/kg/d for 20 d in L braziliensis and L. panamensis ; FU: 12 month, Outcome 1: Complete cure
23.2
23.2. Analysis
Comparison 23: Oral Allopurinol 300 mg for 28d vs IM Meglumine Antimoniate 20mg/kg/d for 20 d in L braziliensis and L. panamensis ; FU: 12 month, Outcome 2: Recurrence
24.1
24.1. Analysis
Comparison 24: Oral Allopurinol 20 mg/k/d + IV Sodium Stibogluconate (20 mg/kg/d (4 doses) x 15d) vs IV Sodium Stibogluconate (same dose) in L. braziliensis; FU: 1 year, Outcome 1: Complete cure
24.2
24.2. Analysis
Comparison 24: Oral Allopurinol 20 mg/k/d + IV Sodium Stibogluconate (20 mg/kg/d (4 doses) x 15d) vs IV Sodium Stibogluconate (same dose) in L. braziliensis; FU: 1 year, Outcome 2: Complete cure; Oral AL plus IVSSG vs IVSSG
25.1
25.1. Analysis
Comparison 25: Oral Allopurinol 20 m/k/d + IV Sodium Stibogluconate (20 mg/kg/d (4 doses) for 28d) vs IV Sodium Stibogluconate (same dose); FU: 12 months, Outcome 1: Complete cure
25.2
25.2. Analysis
Comparison 25: Oral Allopurinol 20 m/k/d + IV Sodium Stibogluconate (20 mg/kg/d (4 doses) for 28d) vs IV Sodium Stibogluconate (same dose); FU: 12 months, Outcome 2: Recurrence
26.1
26.1. Analysis
Comparison 26: Oral Allopurinol 20 mg/kg/d (4 doses) for 15 d vs no treatment in L. panamensis; FU: 12 months, Outcome 1: Complete cure
26.2
26.2. Analysis
Comparison 26: Oral Allopurinol 20 mg/kg/d (4 doses) for 15 d vs no treatment in L. panamensis; FU: 12 months, Outcome 2: Recurrence
27.1
27.1. Analysis
Comparison 27: Oral Allopurinol 300 mg 28 days vs placebo in L. braziliensis and L. panamensis; FU: 12 months, Outcome 1: Complete cure
27.2
27.2. Analysis
Comparison 27: Oral Allopurinol 300 mg 28 days vs placebo in L. braziliensis and L. panamensis; FU: 12 months, Outcome 2: Relapse
28.1
28.1. Analysis
Comparison 28: Oral Allopurinol 20 mg/kg/d + IV Meglumine Antimoniate (20 mg/kg/ d in 4 doses for 15d) vs no treatment in L. panamensis; FU: 12 months, Outcome 1: Complete cure
28.2
28.2. Analysis
Comparison 28: Oral Allopurinol 20 mg/kg/d + IV Meglumine Antimoniate (20 mg/kg/ d in 4 doses for 15d) vs no treatment in L. panamensis; FU: 12 months, Outcome 2: Recurrence
29.1
29.1. Analysis
Comparison 29: Oral miltefosine 50 mg for 28 d vs placebo (same regimen) in L. mexicana, L. panamensis and L. braziliensis; FU: 6 months, Outcome 1: Complete cure
29.2
29.2. Analysis
Comparison 29: Oral miltefosine 50 mg for 28 d vs placebo (same regimen) in L. mexicana, L. panamensis and L. braziliensis; FU: 6 months, Outcome 2: Adverse effects
29.3
29.3. Analysis
Comparison 29: Oral miltefosine 50 mg for 28 d vs placebo (same regimen) in L. mexicana, L. panamensis and L. braziliensis; FU: 6 months, Outcome 3: Recurrence
30.1
30.1. Analysis
Comparison 30: Oral Miltefosine vs Meglumine Antimoniate; FU: 6‐12 months, Outcome 1: Complete cure
30.2
30.2. Analysis
Comparison 30: Oral Miltefosine vs Meglumine Antimoniate; FU: 6‐12 months, Outcome 2: Complete cure in children 2 to 12 years old
30.3
30.3. Analysis
Comparison 30: Oral Miltefosine vs Meglumine Antimoniate; FU: 6‐12 months, Outcome 3: Adverse events
30.4
30.4. Analysis
Comparison 30: Oral Miltefosine vs Meglumine Antimoniate; FU: 6‐12 months, Outcome 4: Speed to healing (% of complete re‐epithelization of lesions at 1 month in cured patients)
31.1
31.1. Analysis
Comparison 31: Different regimens of IM Aminosidine in L. panamensis; FU: 1 year, Outcome 1: Complete cure; AS 12‐g base x 7 days versus AS 12‐g base x 14 days
31.2
31.2. Analysis
Comparison 31: Different regimens of IM Aminosidine in L. panamensis; FU: 1 year, Outcome 2: Complete cure; AS 12‐g base x 7d versus AS 18‐g base for 14 d
31.3
31.3. Analysis
Comparison 31: Different regimens of IM Aminosidine in L. panamensis; FU: 1 year, Outcome 3: Complete cure; AS 12‐g base x 14 d versus AS 18‐g base x 14 d
31.4
31.4. Analysis
Comparison 31: Different regimens of IM Aminosidine in L. panamensis; FU: 1 year, Outcome 4: Adverse effects: AST level 50% higher that normal
32.1
32.1. Analysis
Comparison 32: IM Aminosidine 20mg/kg/day for 20 days vs IM Meglumine Antimoniate 10mg/kg/day for 20 days in L. braziliensis; FU: 1 year, Outcome 1: Complete cure
32.2
32.2. Analysis
Comparison 32: IM Aminosidine 20mg/kg/day for 20 days vs IM Meglumine Antimoniate 10mg/kg/day for 20 days in L. braziliensis; FU: 1 year, Outcome 2: Adverse effects
33.1
33.1. Analysis
Comparison 33: IM Aminosidine for 20 days vs IM Pentamidine Isethionate x 8 applications in L. braziliensis; FU: 1 year, Outcome 1: Complete cure
33.2
33.2. Analysis
Comparison 33: IM Aminosidine for 20 days vs IM Pentamidine Isethionate x 8 applications in L. braziliensis; FU: 1 year, Outcome 2: Adverse effects
34.1
34.1. Analysis
Comparison 34: IM Aminosidine 20 mg/kg/d for 28 d vs IV Meglumine Antimoniate 20 mg/kg for 28 d; L. braziliensis; FU: 1 year, Outcome 1: Complete cure
35.1
35.1. Analysis
Comparison 35: IV Pentamidine (2mg/kg) seven doses vs IV Meglumine Antimoniate (20 mg/kg) for 20 days in L. braziliensis; FU: 6 months, Outcome 1: Complete cure
35.2
35.2. Analysis
Comparison 35: IV Pentamidine (2mg/kg) seven doses vs IV Meglumine Antimoniate (20 mg/kg) for 20 days in L. braziliensis; FU: 6 months, Outcome 2: Adverse effects
36.1
36.1. Analysis
Comparison 36: IM Pentamidine vs IM Meglumine Antimoniate for 20 days in L. braziliensis; FU: 1 year, Outcome 1: Complete cure
36.2
36.2. Analysis
Comparison 36: IM Pentamidine vs IM Meglumine Antimoniate for 20 days in L. braziliensis; FU: 1 year, Outcome 2: Adverse effects
37.1
37.1. Analysis
Comparison 37: Pentamidine Isethionate 7 mg/Kg 4 days vs Pentamidine Isethionate 4 mg/kg 7 days; FU: 12 weeks, Outcome 1: Complete cure
38.1
38.1. Analysis
Comparison 38: Pentamidine Isethionate (7mg/kg): single dose versus two doses versus three doses in L. guyanensis; FU: 6 months, Outcome 1: Complete cure at 6 months
39.1
39.1. Analysis
Comparison 39: 500 mg oral Azithromycin vs 1.5 g parenteral Meglumine Antimoniate in L. braziliensis; FU: 6‐12 months, Outcome 1: Complete cure
40.1
40.1. Analysis
Comparison 40: Oral rehydration solution vs intravenous saline solution for patients treated with amphotericine B in L. braziliensis; FU: 42 days, Outcome 1: Adverse effects: hypokaliemia
41.1
41.1. Analysis
Comparison 41: Topical Paramomycin (15%) + gentamicin (0.5%) vs topical Paramomycin (15%) alone once daily in L. panamensis; FU: 6 months, Outcome 1: Complete cure
41.2
41.2. Analysis
Comparison 41: Topical Paramomycin (15%) + gentamicin (0.5%) vs topical Paramomycin (15%) alone once daily in L. panamensis; FU: 6 months, Outcome 2: Complete cure in children
42.1
42.1. Analysis
Comparison 42: Topical Paramomycin PR‐MBCL TD for 20d vs placebo TD for 20d in L. panamensis and L. mexicana; FU: 12 months, Outcome 1: Complete cure
43.1
43.1. Analysis
Comparison 43: Paromomycin 15% plus methylbenzonium chloride (PR–MBCL) 30 days versus meglumine antimoniate (MA) 20 mg/kg/day 10 days. FU: 3 months, Outcome 1: Recurrence
43.2
43.2. Analysis
Comparison 43: Paromomycin 15% plus methylbenzonium chloride (PR–MBCL) 30 days versus meglumine antimoniate (MA) 20 mg/kg/day 10 days. FU: 3 months, Outcome 2: Speed to healing
44.1
44.1. Analysis
Comparison 44: Topical Paromomycin PR‐MBCL (TD x 10d) + IV Meglumine Antimoniate x 7 d vs Paromomycin PR‐MBCL + IV Meglumine Antimoniate x 3 d in L. braziliensis and L. panamensis; FU: 1 year, Outcome 1: Complete cure
45.1
45.1. Analysis
Comparison 45: Topical Paromomycin PR‐MBCL (TD x 10d) + IV Meglumine Antimoniate x 7 d vs Placebo + IV Meglumine Antimoniate x 7 d in L. braziliensis and L. panamensis; FU: 1 year, Outcome 1: Complete cure
46.1
46.1. Analysis
Comparison 46: Topical Paromomycin PR‐MBCL (TD x 10d) + IV Meglumine Antimoniate x 3 d vs Placebo + IV Meglumine Antimoniate x 7 d in L. braziliensis and L. panamensis; FU: 1 year, Outcome 1: Complete cure
47.1
47.1. Analysis
Comparison 47: Topical Paromomycin PR‐MBCL (TD x 10d) + IV Meglumine Antimoniate x 7 d vs IV Meglumine Antimoniate for 20 d in L. braziliensis and L. panamensis; FU: 1 year, Outcome 1: Complete cure
48.1
48.1. Analysis
Comparison 48: Topical Paromomycin PR‐MBCL (TD x 10d) + IV Meglumine Antimoniate x 3 d vs IV Meglumine Antimoniate for 20 d in L. braziliensis and L. panamensis; FU: 1 year, Outcome 1: Complete cure
49.1
49.1. Analysis
Comparison 49: Paromomycin (15%) in Aquaphilic versus intralesional pentamidine (30 mg/ ml) versus Aquaphilic vehicle in L. braziliensis; FU: 6 months, Outcome 1: Complete cure at 6 months
50.1
50.1. Analysis
Comparison 50: Topical Aminoglycoside WR279396 versus placebo in L. panamensis; FU: 6 months, Outcome 1: Adverse effects: mild side effects
50.2
50.2. Analysis
Comparison 50: Topical Aminoglycoside WR279396 versus placebo in L. panamensis; FU: 6 months, Outcome 2: Speed to healing
51.1
51.1. Analysis
Comparison 51: Topical 3% amphotericin B cream twice a day versus three times a day in L. panamensis and L. braziliensis; FU: 6 months., Outcome 1: Complete cure at 3 months
51.2
51.2. Analysis
Comparison 51: Topical 3% amphotericin B cream twice a day versus three times a day in L. panamensis and L. braziliensis; FU: 6 months., Outcome 2: Complete cure at 6 months
52.1
52.1. Analysis
Comparison 52: Nitric oxide patch (≈3.5 μmol NO/cm2 /day, NOP) + IM placebo vs IM Meglumine Antimoniate (20 mg/kg/day) + placebo patch, Outcome 1: Complete cure
53.1
53.1. Analysis
Comparison 53: 7.5% Imiquimod cream x 20 days + IV Meglumine Antimoniate for 20 days vs IV Meglumine Antimoniate x 20 days in L. braziliensis, L. peruviana, L. mexicana and L. amazonensis; FU: 3 months, Outcome 1: Complete cure
54.1
54.1. Analysis
Comparison 54: Topical Imiquimod 5% + IV Meglumine Antimoniate vs placebo + IM/IV Meglumine Antimoniate in L. braziliensis, L. guyanensis and L. peruviana; FU: 1 year, Outcome 1: Complete cure
54.2
54.2. Analysis
Comparison 54: Topical Imiquimod 5% + IV Meglumine Antimoniate vs placebo + IM/IV Meglumine Antimoniate in L. braziliensis, L. guyanensis and L. peruviana; FU: 1 year, Outcome 2: Adverse effects in patients in which previous treatment failed
55.1
55.1. Analysis
Comparison 55: 7.5% Imiquimod cream x 20 days vs IV Meglumine Antimoniate x 20 days in L. braziliensis, L. peruviana, L. mexicana and L. amazonensis; FU: 3 months, Outcome 1: Complete cure
56.1
56.1. Analysis
Comparison 56: Thermotherapy versus placebo in L.braziliensis and L. mexicana. FU: 13 weeks., Outcome 1: Microbiological or histopathological cure of skin lesions at 13 weeks
57.1
57.1. Analysis
Comparison 57: Thermotherapy (at 50º for 30 seconds) vs Meglumine Antimoniate (20 mg Sb5/kg/day) in L. panamensis and L. braziliensis; FU: 6 months, Outcome 1: Complete cure
57.2
57.2. Analysis
Comparison 57: Thermotherapy (at 50º for 30 seconds) vs Meglumine Antimoniate (20 mg Sb5/kg/day) in L. panamensis and L. braziliensis; FU: 6 months, Outcome 2: Microbiological or histopathological cure of skin lesions
58.1
58.1. Analysis
Comparison 58: Thermotherapy (at 50º for 30 seconds) vs oral Miltefosine (total dose of 4,200 mg) in L. panamensis and L. brazililensis; FU: 6 months, Outcome 1: Complete cure
59.1
59.1. Analysis
Comparison 59: Cryotherapy (5–20 seconds) vs placebo cream in L.braziliensis,L. amazonensis, L. guyanensis and L. lainsoni; FU: 6 months, Outcome 1: Complete cure
60.1
60.1. Analysis
Comparison 60: Cryotherapy (5–20 seconds) vs IL SB (0.008 μL)/mm2 in L.braziliensis,L. amazonensis, L. guyanensis and L. lainsoni; FU: 6 months, Outcome 1: Complete cure
61.1
61.1. Analysis
Comparison 61: Vaccine three doses vs IM Meglumine Antimoniate (50 mg/kg in 2‐3 series of 20 daily injections) in L. braziliensis; FU: 6 months, Outcome 1: Complete cure
62.1
62.1. Analysis
Comparison 62: Intradermal vaccine of biological LEISH‐F2 + MPL‐SE versus sodium stibogluconate in L. Peruvian. FU: up to 335 days, Outcome 1: Adverse effects not serious
63.1
63.1. Analysis
Comparison 63: BCG (three doses) vs IM Meglumine Antimoniate (50 mg/kg /day 40‐60 injections) in L. braziliensis; FU: 6 months, Outcome 1: Complete cure
64.1
64.1. Analysis
Comparison 64: Oral pentoxifylline 400 mg 3 times daily for 30d + IV Sodium Stibogluconate 20 mg/kg /d vs placebo + IV Sodium Stibogluconate in L. braziliensis; FU: 4 months, Outcome 1: Complete cure
64.2
64.2. Analysis
Comparison 64: Oral pentoxifylline 400 mg 3 times daily for 30d + IV Sodium Stibogluconate 20 mg/kg /d vs placebo + IV Sodium Stibogluconate in L. braziliensis; FU: 4 months, Outcome 2: Speed to healing
65.1
65.1. Analysis
Comparison 65: Oral Pentoxifylline (1200 mg/day) + IM Meglumine Antimoniate (20 mg/ kg /day) vs IM Meglumine Antimoniate + placebo; FU: 26 weeks, Outcome 1: Complete cure
66.1
66.1. Analysis
Comparison 66: Oral Pentoxifylline (1200 mg) + IM Meglumine Antimoniate (20mg/kg) vs IM Meglumine Antimoniate (20mg/kg) + placebo L. braziliensis; FU: 90‐180 days, Outcome 1: Complete cure
67.1
67.1. Analysis
Comparison 67: GM‐CSF combined with IV sodium stibogluconate versus IV sodium stibogluconate in L. braziliensis. FU 6 months, Outcome 1: Speed to healing
68.1
68.1. Analysis
Comparison 68: Subcutaneous interferon‐Gamma plus IV MA versus IVMA alone in L. braziliensis and L. mexicana; FU: 1 year, Outcome 1: Complete cure; 10‐day IV MA+10‐day IFN‐γ versus 10‐day IV MA+10‐day placebo
68.2
68.2. Analysis
Comparison 68: Subcutaneous interferon‐Gamma plus IV MA versus IVMA alone in L. braziliensis and L. mexicana; FU: 1 year, Outcome 2: Complete cure; 10‐day IV MA+ 10‐day IFN‐γ versus 20‐day IV MA
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References

References to studies included in this review

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D'Oliveira 1997 {published data only}
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Oliveira‐Neto 1997 {published data only}
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Oster 1985 {published data only}
    1. Oster CN, Chulay JD, Hendricks LD, Pamplin CL III, Ballou WR, Berman JD, et al. American cutaneous leishmaniasis: a comparison of three sodium stibogluconate treatment schedules. American Journal of Tropical Medicine and Hygiene 1985;34(5):856-60. [CENTRAL: CN-00039556] - PubMed
Palacios 2001 {published data only}
    1. Palacios R, Osorio LE, Grajales LF, Ochoa MT. Treatment failure in children in a randomized clinical trial with 10 and 20 days of meglumine antimoniate for cutaneous leishmaniasis due to leishmania viannia species. American Journal of Tropical Medicine and Hygiene 2001;64(3-4):187-93. [CENTRAL: CN-00349275] - PubMed
Prates 2017 {published data only}
    1. Prates FV, Dourado ME, Silva SC, Schriefer A, Guimarães LH, Brito MD, et al. Fluconazole in the treatment of cutaneous leishmaniasis caused by Leishmania braziliensis: a randomized controlled trial. Clinical Infectious Diseases 2017;64(1):67-71. [CENTRAL: CN-01444134] - PubMed
Ravis 2013 {published data only}
    1. Ravis WR, Llanos-Cuentas A, Sosa N, Kreishman-Deitrick M, Kopydlowski KM, Nielsen C, et al. Pharmacokinetics and absorption of paromomycin and gentamicin from topical creams used to treat cutaneous leishmaniasis. Antimicrobial Agents and Chemotherapy 2013;57(10):4809-15. [CENTRAL: CN-00916363] - PMC - PubMed
Rubiano 2012 {published data only}
    1. Rubiano LC, Miranda MC, Muvdi Arenas S, Montero LM, Rodríguez-Barraquer I, Garcerant D, et al. Noninferiority of miltefosine versus meglumine antimoniate for cutaneous leishmaniasis in children. Journal of Infectious Diseases 2012;205(4):684-92. [CENTRAL: CN-00814449] - PMC - PubMed
Saenz 1987 {published data only}
    1. Saenz RE, Paz HM, Johnson CM, Narvaez E, De Vasquez AM. Evaluation of the effectiveness and toxicity of pentostam and glucantime in the treatment of cutaneous leishmaniasis [Evaluación de la effectividad y toxicidad del pentostam y del glucantime en el tratamiento de la leishmaniasis cutanea]. Revista Médica de Panamá 1987;12(3):148-57. [CENTRAL: CN-01139764] - PubMed
Saenz 1990 {published data only}
    1. Saenz RE, Paz H, Berman JD. Efficacy of ketoconazole against leishmania braziliensis panamensis cutaneous leishmaniasis. American Journal of Medicine 1990;89(2):147-55. [CENTRAL: CN-00069419] - PubMed
Saheki 2017 {published data only}
    1. Lyra MR. Phase III clinical trial for American cutaneous leishmaniasis. Equivalence between high and low dose schemes of meglumine antimoniate [Masters thesis] [Ensaio clínico fase iii para leishmaniose tegumentar americana forma cutânea. Equivalência entre esquemas de alta e baixa dose de antimoniato de meglumina]. www.arca.fiocruz.br/handle/icict/14378 (accessed prior to 1 February 2019).
    1. Ribeiro MN, Pimentel MI, Schubach Ade O, Oliveira R de V, Teixeira JL, Leite MP, et al. Factors associated with adherence to different treatment schemes with meglumine antimoniate in a clinical trial for cutaneous leishmaniasis. Revista do Instituto de Medicina Tropical de Sao Paulo 2014;56(4):291-6. - PMC - PubMed
    1. Saheki MN, Lyra MR, Bedoya-Pacheco SJ, Antonio LF, Pimentel MIF, Salgueiro MM, et al. Low versus high dose of antimony for American cutaneous leishmaniasis: a randomized controlled blind non-inferiority trial in Rio de Janeiro, Brazil. PLOS One 2017;12(5):e0178592. [CENTRAL: CN-01413190] - PMC - PubMed
    1. Saheki MN. A randomized, controlled, single blind, non-inferiority trial of low dose versus high dose meglumine antimoniate for American cutaneous leishmaniasis in Rio de Janeiro, Brazil [Masters thesis] [Ensaio clínico de não inferioridade, randomizado, controlado, cego,de antimoniato de meglumina em dose baixa versus dose alta paraleishmaniose cutânea americana no Rio de Janeiro, Brasil]. www.arca.fiocruz.br/handle/icict/12458 (accessed prior to 1 February 2019).
Sampaio 2019 {published data only}
    1. Sampaio RN, Silva Jsfe, Paula CD, Porto C, Motta Jocd, Pereira LI, et al. A randomized, open-label clinical trial comparing the long-term effects of miltefosine and meglumine antimoniate for mucosal leishmaniasis. Revista da Sociedade Brasileira de Medicina Tropical 2019;52:e20180292. - PubMed
Santos 2004 {published data only}
    1. Santos JB, De Jesus AR, Machado PR, Magalhâes A, Salgado K, Carvalho EM, et al. Antimony plus recombinant human granulocyte-macrophage colony-stimulating factor applied topically in low doses enhances healing of cutaneous leishmaniasis ulcers: a randomized, double-blind, placebo-controlled study. Journal of Infectious Diseases 2004;190(10):1793-6. [CENTRAL: CN-00492355] - PubMed
Sosa 2013 {published data only}
    1. Sosa N, Capitan Z, Nieto J, Nieto M, Calzada J, Paz H, et al. Randomized, double-blinded, phase 2 trial of wr 279,396 (paromomycin and gentamicin) for cutaneous leishmaniasis in Panama. American Journal of Tropical Medicine and Hygiene 2013;89(3):557-63. [CENTRAL: CN-00876215] - PMC - PubMed
Sosa 2019 {published data only}
    1. NCT01790659. Phase 3 study of Walter Reed (WR) 279,396 and paromomycin alone for the treatment of cutaneous leishmaniasis in Panama [A randomized, double-blind, pivotal phase 3 study of WR 279,396 (paromomycin + gentamicin topical cream) and paromomycin alone topical cream for the treatment of cutaneous leishmaniasis in Panama]. clinicaltrials.gov/ct2/show/study/NCT01790659 (first received 13 February 2013).
    1. Sosa N, Pascale JM, Jimenez AI, Norwood JA, Kreishman-Detrick M, Weina PJ, et al. Topical paromomycin for New World cutaneous leishmaniasis. PLOS Neglected Tropical Diseases 2019;13(5):e0007253. - PMC - PubMed
Soto 1994a {published data only}
    1. Soto J, Grogl M, Berman J, Olliaro P. Limited efficacy of injectable aminosidine as single-agent therapy for Colombian cutaneous leishmaniasis. Transactions of the Royal Society of Tropical Medicine and Hygiene 1994;88(6):695-8. [CENTRAL: CN-00111780] - PubMed
Soto 1998 {published data only}
    1. Soto J, Fuya P, Herrera R, Berman J. Topical paromomycin/methylbenzethonium chloride plus parenteral meglumine antimoniate as treatment for American cutaneous leishmaniasis: controlled study. Clinical Infectious Diseases 1998;26(1):56-8. [CENTRAL: CN-00147306] - PubMed
Soto 2002 {published data only}
    1. Soto JM, Toledo JT, Gutierrez P, Arboleda M, Nicholls RS, Padilla JR, et al. Treatment of cutaneous leishmaniasis with a topical antileishmanial drug (WR279396): phase 2 pilot study. American Journal of Tropical Medicine and Hygiene 2002;66(2):147-51. [CENTRAL: CN-00390421] - PubMed
Soto 2004a {published data only}
    1. Soto J, Valda-Rodriguez L, Toledo J, Vera-Navarro L, Luz M, Monasterios-Torrico H, et al. Comparison of generic to branded pentavalent antimony for treatment of new world cutaneous leishmaniasis. American Journal of Tropical Medicine and Hygiene 2004;71(5):577-81. [CENTRAL: CN-00504004] - PubMed
Soto 2004b {published data only}
    1. Soto J, Arana BA, Toledo J, Rizzo N, Vega JC, Diaz A, et al. Miltefosine for new world cutaneous leishmaniasis. Clinical Infectious Diseases 2004;38(9):1266-72. [CENTRAL: CN-00470183] - PubMed
Soto 2008 {published data only}
    1. Soto J, Rea J, Balderrama M, Toledo J, Soto P, Valda L, et al. Efficacy of miltefosine for Bolivian cutaneous leishmaniasis. American Journal of Tropical Medicine and Hygiene 2008;78(2):210-1. [CENTRAL: CN-00629911] - PubMed
Soto 2013 {published data only}
    1. Soto J, Rojas E, Guzman M, Verduguez A, Nena W, Maldonado M, et al. Intralesional antimony for single lesions of Bolivian cutaneous leishmaniasis. Clinical Infectious Diseases 2013;56(9):1255-60. [CENTRAL: CN-00877427] - PubMed
Soto 2016a {published data only}
    1. Soto J, Paz D, Rivero D, Soto P, Quispe J, Toledo J, et al. Intralesional pentamidine: a novel therapy for single lesions of Bolivian cutaneous leishmaniasis. American Journal of Tropical Medicine and Hygiene 2016;94(4):852-6. [CENTRAL: CN-01154109] - PMC - PubMed
Soto 2016b {published data only}
    1. Soto J, Paz D, Rivero D, Soto P, Quispe J, Toledo J, et al. Intralesional pentamidine: a novel therapy for single lesions of Bolivian cutaneous leishmaniasis. American Journal of Tropical Medicine and Hygiene 2016;94(4):852-6. [CENTRAL: CN-01154109] - PMC - PubMed
Soto 2019 {published data only}
    1. Soto J, Soto P, Ajata A, Luque C, Tintaya C, Paz D, et al. Topical 15% paromomycin-aquaphilic for Bolivian leishmania braziliensis cutaneous leishmaniasis: a randomized, placebo-controlled trial. Clinical Infectious Diseases 2019;68(5):844-9. - PubMed
Souza 1998 {published data only}
    1. Souza e Souza I, Lima IC, Alecrim JF. American cutaneous leishmaniasis: therapeutic study of pentamidine isotionate versus N-metil-glucantime. Journal of the European Academy of Dermatology and Venereology : JEADV 1998;11(Suppl 2):S153.
Toledo 2014 {published data only}
    1. Toledo Junior A, Daher AB, Amaral TA, Carvalho SF, Romero GA, Rabello A. Poor response to azithromycin in cutaneous leishmaniasis leading to a premature interruption of a multicentric phase III clinical trial in Brazil. Revista Da Sociedade Brasileira de Medicina Tropical 2014;47(6):756-62. [CENTRAL: CN-01048573] - PubMed
Vélez 1997 {published data only}
    1. Vélez I, Agudelo S, Hendrickx E, Puerta J, Grogl M, Modabber F, et al. Inefficacy of allopurinol as monotherapy for Colombian cutaneous leishmaniasis: a randomized, controlled trial. Annals of Internal Medicine 1997;126(3):232-6. [CENTRAL: CN-00135976] - PubMed
Vélez 2010 {published data only}
    1. López L, Cruz C, Godoy G, Robledo SM, Vélez ID. Thermotherapy effective and safer than miltefosine in the treatment of cutaneous leishmaniasis in Colombia. Revista do Instituto de Medicina Tropical de Sao Paulo 2013;55(3):S0036-46652013000300197. - PubMed
    1. López L, Robayo M, Vargas M, Vélez ID. Thermotherapy. An alternative for the treatment of American cutaneous leishmaniasis. Trials 2012;13:58. - PMC - PubMed
    1. Vélez I, Lopez L, Sanchez X, Mestra L, Rojas C, Rodriguez E. Efficacy of miltefosine for the treatment of American cutaneous leishmaniasis. American Journal of Tropical Medicine and Hygiene 2010;83(2):351-6. [CENTRAL: CN-00760206] - PMC - PubMed

References to studies excluded from this review

Armijos 2004B {published data only}
    1. Armijos RX, Weigel MM, Calvopina M, Hidalgo A, Cevallos W, Correa J. Safety, immunogeneicity, and efficacy of an autoclaved leishmania amazonensis vaccine plus BCG adjuvant against New World cutaneous leishmaniasis. Vaccine 2004;22(9-10):1320-6. [CENTRAL: CN-00471149] - PubMed
De Luca 1999 {published data only}
    1. De Luca PM, Mayrink W, Alves CR, Coutinho SG, Oliveira MP, Bertho AL, et al. Evaluation of the stability and immunogenicity of autoclaved and nonautoclaved preparations of a vaccine against American tegumentary leishmaniasis. Vaccine 1999;17(9-10):1179-85. [CENTRAL: CN-00305330] - PubMed
De Luca 2001 {published data only}
    1. De Luca PM, Mayrink W, Pinto JA, Coutinho SG, Santiago MA, Toledo VP, et al. A randomized double-blind placebo-controlled trial to evaluate the immunogenicity of a candidate vaccine against American tegumentary leishmaniasis. Acta Tropica 2001;80(3):251-60. [CENTRAL: CN-00375249] - PubMed
De Luca 2003 {published data only}
    1. De Luca PM, Mayrink W, Santiago MA, Nogueira R, Conceição-Silva F, Mélo G, et al. Randomized, double-blind, placebo-controlled study on the immunogenicity of the leishmanin skin test. Transactions of the Royal Society of Tropical Medicine and Hygiene 2003;97(6):709-12. [CENTRAL: CN-00551996] - PubMed
Deps 2000 {published data only}
    1. Deps PD, Viana MC, Falqueto A, Dietze R. Evaluation of the efficacy and toxicity of N-methyl-glucamine vs BP88 Sodium Stibogluconate in the treatment of localized cutaneous leishmaniasis. Revista da Sociedade Brasileira de Medicina Tropical 2000;33(6):535-43. [CENTRAL: CN-00399871] - PubMed
Fagundes 2007 {published data only}
    1. Fagundes A, Marzochi MC, Perez M, Schubach A, Ferreira A, Silva JP, et al. Skin reactivity to thimerosal and phenol-preserved Montenegro antigen in Brazil. Acta Tropica 2007;101(1):25-30. [CENTRAL: CN-00577747] - PubMed
Falquete 2002 {published data only}
    1. Falquete A, Sessa AP. Leishmaniose tegumentar americana. In: Veronesi R, Focaccia R, editors(s). Tratado de infectologia. Sâo Paulo: Atheneu, 2002:1241-53.
Gardlo 2003 {published data only}
    1. Gardlo K, Horska Z, Enk CD, Rauch L, Megahed M, Ruzicka T, et al. Treatment of cutaneous leishmaniasis by photodynamic therapy. Journal of the American Academy of Dermatology 2003;48(6):893-6. [CENTRAL: CN-00466020] - PubMed
Hendrickx 1998 {published data only}
    1. Hendrickx EP, Agudelo SP, Munoz DL, Puerta JA, Velez Bernal ID. Lack of efficacy of mefloquine in the treatment of New World cutaneous leishmaniasis in Colombia. American Journal of Tropical Medicine and Hygiene 1998;59(6):889-92. [PMID: ] - PubMed
Hepburn 1993 {published data only}
    1. Hepburn NC, Tidman MJ, Hunter JA. Cutaneous leishmaniasis in British troops from Belize. British Journal of Dermatology 1993;128(1):63-8. [PMID: ] - PubMed
Hepburn 1994b {published data only}
    1. Hepburn NC, Siddique I, Howie AF, Beckett GJ, Hayes PC. Hepatotoxicity of sodium stibogluconate therapy for American cutaneous leishmaniasis. Transactions of the Royal Society of Tropical Medicine and Hygiene 1994;88(4):453-5. [CENTRAL: CN-00119186] - PubMed
Herwaldt 1992 {published data only}
    1. Herwaldt BL, Arana BA, Navin TR. The natural history of cutaneous leishmaniasis in Guatemala. Journal of Infectious Diseases 1992;165(3):518-27. [PMID: ] - PubMed
Krause 1999 {published data only}
    1. Krause G, Kroeger A. Topical paromomycin/methylbenzethonium chloride plus parenteral meglumine antimonate as treatment of American cutaneous leishmaniasis: controlled study. Clinical Infectious Diseases 1999;29(2):466-7. [PMID: ] - PubMed
Laguna‐Torres 1999 {published data only}
    1. Laguna-Torres VA, Silva CA, Correia D, Carvalho EM, Magalhâes AV, De Oliveira Macêdo V. Efficacy of mefloquine in the treatment of skin leishmaniasis in an endemic area of leishmania (viannia) braziliensis. Revista da Sociedade Brasileira de Medicina Tropical 1999;32(5):529-32. [CENTRAL: CN-00414710] - PubMed
Llanos 1991 {published data only}
    1. Llanos A, Cieza J, Bernardo J, Echevarria J, Biaggioni I, Sabra R, et al. Effect of salt supplementation on amphotericin B nephrotoxicity. Kidney International 1991;40(2):302-8. [CENTRAL: CN-00079305] - PubMed
Llanos‐Cuentas 2010 {published data only}
    1. Llanos-Cuentas A, Calderon W, Cruz M, Ashman JA, Alves FP, Coler RN, et al. A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine when used in combination with sodium stibogluconate for the treatment of mucosal leishmaniasis. Vaccine 2010;28(46):7427-35. [CENTRAL: CN-00768896] - PubMed
Monjour 1994 {published data only}
    1. Monjour L, Neogy AB, Vouldoukis I, Silva OA, Boisnic S, Brito ME, et al. Exploitation of parasite derived antigen in therapeutic success of human cutaneous leishmaniasis in Brazil. Memórias do Instituto Oswaldo Cruz 1994;89(3):479-83. [CENTRAL: CN-00118323] - PubMed
Motta 2012 {published data only}
    1. Motta JO, Sampaio RN. A pilot study comparing low-dose liposomal amphotericin B with N-methyl glucamine for the treatment of American cutaneous leishmaniasis. Journal of the European Academy of Dermatology and Venereology : JEADV 2012;26(3):331-5. [CENTRAL: CN-00882917] - PubMed
Nascimento 1990 {published data only}
    1. Nascimento E, Mayrink W, Da Costa CA, Michalick MS, Melo MN, Barros GC, et al. Vaccination of humans against cutaneous leishmaniasis: cellular and humoral inmune responses. Infection and Immunity 1990;58(7):2198-203. [CENTRAL: CN-00068740] - PMC - PubMed
Oliveira‐Neto 2000 {published data only}
    1. Oliveira-Neto MP, Mattos M, Primez C, Fernandes O, Gonçalves-Costa SC, Souza CF, et al. Mucosal leishmaniasis ("espundia") responsive to low dose of N-methyl glucantime in Rio de Janeiro, Brazil. Revista do Instituto de Medicina Tropical de São Paulo 2000;42(6):321-5. [CENTRAL: CN-00372731] - PubMed
Rodriguez 1995 {published data only}
    1. Rodriguez LV, Dedet JP, Paredes V, Mendoza C, Cardenas F. A randomized trial of amphotericin B alone or in combination with itraconazole in the treatment of mucocutaneous leishmaniasis. Memórias do Instituto Oswaldo Cruz 1995;90(4):525-8. [CENTRAL: CN-00121054] - PubMed
Saldanha 2000 {published data only}
    1. Saldanha AC, Romero GA, Guerra C, Merchan-Hamann E, Macedo Vde O. Comparative study between sodium stibogluconate BP 88 and meglumine antimoniate in cutaneous leishmaniasis treatment. II. Biochemical and cardiac toxicity. Revista da Sociedade Brasileira de Medicina Tropical 2000;33(4):383-8. [PMID: ] - PubMed
Soto 1994b {published data only}
    1. Soto J, Buffet P, Grogl M, Berman J. Successful treatment of Colombian cutaneous leishmaniasis with four injections of pentamidine. American Journal of Tropical Medicine and Hygiene 1994;50(1):107-11. [CENTRAL: CN-00098861] - PubMed
Soto 1995 {published data only}
    1. Soto J, Hernandez N, Mejia H, Grogl M, Berman J. Successful treatment of New World cutaneous leishmaniasis with a combination of topical paromomycin/methylbenzethonium chloride and injectable meglumine antimonate. Clinical Infectious Diseases 1995;20(1):47-51. [CENTRAL: CN-00113359] - PubMed
Soto‐Mancipe 1993 {published data only}
    1. Soto-Mancipe J, Grogl M, Berman JD. Evaluation of pentamidine for the treatment of cutaneous leishmaniasis in Colombia. Clinical Infectious Diseases 1993;16(3):417-25. [CENTRAL: CN-00091785] - PubMed
Urcuyo 1982 {published data only}
    1. Urcuyo FG, Zaias N. Oral ketoconazole in the treatment of leishmaniasis. International Journal of Dermatology 1982;21(7):414-6. [PMID: ] - PubMed
Veiga 1985 {published data only}
    1. Veiga JP, Rosa TT, Kimachi T, Wolff ER, Sampaio RN, Gagliardi AR, et al. [Renal function in patients with mucocutaneous leishmaniasis treated with pentavalent antimony compounds]. Revista do Instituto de Medicina Tropical de Sao Paulo 1985;27(6):298-302. [PMID: ] - PubMed
Vélez 2005 {published data only}
    1. Vélez ID, Gilchrist K, Arbelaez MP, Rojas CA, Puerta JA, Antunes CM, et al. Failure of a killed Leishmania amazonensis vaccine against American cutaneous leishmaniasis in Colombia. Transactions of the Royal Society of Tropical Medicine and Hygiene 2005;99(8):593-8. [CENTRAL: CN-00521907] - PubMed
Wortmann 2002 {published data only}
    1. Wortmann G, Scoot Miller R, Oster C, Jackson J, Aronson N. A randomized, double-blind study of the efficacy of a 10- or 20-day course of sodium stibogluconate for treatment of cutaneous leishmaniasis in United States military personnel. Clinical Infectious Diseases 2002;35(3):261-7. [PMID: ] - PubMed

References to studies awaiting assessment

NCT00004755 {published data only}
    1. NCT00004755. Allopurinol, glucantime, or allopurinol/glucantime for cutaneous leishmaniasis in Brazil [Phase II randomized study of allopurinol versus glucantime versus allopurinol/glucantime for cutaneous leishmaniasis in Brazil]. clinicaltrials.gov/ct2/show/record/NCT00004755 (first received 25 February 2000).
NCT00111514 {published data only}
    1. NCT00111514. Study to evaluate the Leish-111F + MPL-SE vaccine in the treatment of mucosal leishmaniasis [A phase 1, randomized, double-blind, placebo-controlled, dose-escalating study to evaluate safety, tolerability, and immunogenicity of Leish-111f + MPL-SE vaccine in combination with pentavalent antimony in treatment of mucosal leishmaniasis]. clinicaltrials.gov/ct2/show/study/NCT00111514 (first received 23 May 2005).
NCT00111553 {published data only}
    1. NCT00111553. Study to evaluate the Leish-111F + MPL-SE vaccine in the treatment of cutaneous leishmaniasis [Randomized, double-blind, adjuvant- and placebo-controlled, dose-escalating study to evaluate safety, tolerability, and immunogenicity of Leish-111f + MPL-SE vaccine with meglumine antimoniate (glucantime) in cutaneous leishmaniasis]. clinicaltrials.gov/ct2/show/study/NCT00111553 (first received 24 May 2005).
NCT00317980 {published data only}
    1. NCT00317980. Safety and efficacy of low-dose pentavalent antimony for treatment of cutaneous leishmaniasis (Lowdosesb) [Phase IV randomized controlled clinical trial to evaluate the safety and efficacy of low-dose pentavalent antimony compared to the standard dose in patients with cutaneous leishmaniasis caused by Leishmania (Viannia) braziliensis]. clinicaltrials.gov/ct2/show/study/NCT00317980 (first received 25 April 2006).
NCT00973128 {published data only}
    1. NCT0973128. Reduced doses of antimony plus ranulocyte monocyte colony stimulating factor (GM-CSF) for cutaneous leishmaniasis (GMCSFSbv) [Reduced doses of antimony plus recombinant human GM-CSF compared with antimony in standard doses for cutaneous leishmaniasis: a randomized, single-blind, placebo-controlled, pilot study]. clinicaltrials.gov/ct2/show/study/NCT0973128 (first received 9 September 2009).
NCT01380301 {published data only}
    1. NCT01380301. Treatment of cutaneous leishmaniasis with a combination of miltefosine and antimony [Treatment of Bolivian cutaneous leishmaniasis with a combination of short courses of miltefosine and antimony]. clinicaltrials.gov/ct2/show/study/NCT01380301 (first received 27 June 2011).
NCT01380314 {published data only}
    1. NCT01380314. Oral miltefosine plus topical imiquimod to treat cutaneous leishmaniasis [Treatment of Bolivian cutaneous leishmaniasis with a combination of oral miltefosine plus topical imiquimod 5%]. clinicaltrials.gov/ct2/show/record/NCT01380314 (first received 27 June 2011).
NCT01464242 {published data only}
    1. NCT01464242. Add-on study of pentoxifylline in cutaneous leishmaniasis (GT) [Therapeutic gain of adding the immunomodulator pentoxifylline to the treatment of cutaneous leishmaniasis]. clinicaltrials.gov/ct2/show/record/NCT01464242 (first received 3 November 2011).
NCT03294161 {published data only}
    1. NCT03294161. Fourth-generation immucillin derivative DI4G associated therapy in cutaneous leishmaniasis [Transition-state analog inhibitor of human purine nucleoside phosphorylase as an adjunct in cutaneous leishmaniasis therapy: a randomized and controlled trial]. clinicaltrials.gov/ct2/show/study/NCT03294161 (first received 26 September 2017).
Silva 2006 {published data only}
    1. Silva SY, Rueda LC, Lopez M, Velez ID, Rueda-Clausen CF, Smith DJ, et al. Double blind, randomized controlled trial, to evaluate the effectiveness of a controlled nitric oxide releasing patch versus meglumine antimoniate in the treatment of cutaneous leishmaniasis [NCT00317629]. Trials 2006;7:14. [PMID: ] - PMC - PubMed

References to ongoing studies

NCT00537953 {published data only}
    1. NCT00537953. Short course of miltefosine and antimony to treat cutaneous leishmaniasis in Bolivia [Efficacy and safety of a short course of the combination of miltefosine and antimony to treat cutaneous leishmaniasis in Bolivia]. clinicaltrials.gov/ct2/show/study/NCT00537953 (first received 2 October 2007).
NCT01301937 {published data only}
    1. NCT01301937. Low antimonial dosage in American mucosal leishmaniasis [Phase III clinical trial for mucosal or mucocutaneous leishmaniasis. Comparison between the standard and alternative antimonial schemes]. clinicaltrials.gov/ct2/show/study/NCT01301937 (first received 23 February 2011).
NCT02530697 {published data only}
    1. NCT02530697. The association of miltefosine and pentoxifylline to treat mucosal leishmaniasis: a clinical trial in Brazil. clinicaltrials.gov/ct2/show/study/NCT02530697 (first received 21 August 2015).
NCT02687971 {published data only}
    1. NCT02687971. Thermotherapy + a short course of miltefosine for the treatment of uncomplicated cutaneous leishmaniasis in the New World. clinicaltrials.gov/ct2/show/study/NCT02687971 (first received 23 February 2016).
NCT03023111 {published data only}
    1. NCT03023111. Miltefosine and GM-CSF in cutaneous leishmaniasis: a randomized and controlled trial. clinicaltrials.gov/ct2/show/NCT03023111 (first received 18 January 2017).
NCT03084952 {published data only}
    1. NCT03084952. Phase 2 trial to evaluate 18-methoxycoronaridine efficacy, safety and tolerability in cutaneous leishmaniasis patients. clinicaltrials.gov/ct2/show/study/NCT03084952 (first received 21 March 2017).
NCT03829917 {published data only}
    1. NCT03829917. Oral miltefosine plus topical paromomycin In American cutaneous leishmaniasis. clinicaltrials.gov/show/nct03829917 (first received 1 August 2019).
NCT04072874 {published data only}
    1. NCT04072874. Evaluation of the safety and clinical activity of Curaleish lotion and cream in the topical treatment of cutaneous leishmaniasis in Colombia. clinicaltrials.gov/ct2/show/NCT04072874 (first received 4 September 2019).
NTR2076 {published data only}
    1. NTR2076. Treatment of cutaneous leishmaniasis with pentamidine isethionate in Suriname; a comparison study between two treatment regimes, 3 days vs 7 days [Clinical, parasitological and pharmaco-economical evaluation of a 3 days versus 7 days pentamidine isethionate regimen for cutaneous leishmaniasis in Suriname]. www.trialregister.nl/trialreg/admin/rctview.asp?TC=2076 (first received 25 September 2009).
PER‐007‐16 {published data only}
    1. PER-007-16. A randomized, open label multicenter study to determine the efficacy and safety of combining thermotherapy and a short course of miltefosine for the treatment of uncomplicated cutaneous leishmaniasis in the New World. www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevo.asp?ver=EN&nu... (first received 5 July 2016).
RBR‐5r93wn {published data only}
    1. RBR-5r93wn. Comparison of the effect and toxicity between two options for the treatment of Mucosal Leishmaniasis: miltefosin and Liposomal Anfotericin B. apps.who.int/trialsearch/Trial2.aspx?TrialID=RBR-5r93wn (first received 15 January 2018).
RBR‐6mk5n4 {published data only}
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