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. 2016 Feb 19;11(2):e0149697. doi: 10.1371/journal.pone.0149697

Table 1. Main methodological characteristics of the studies.

Year, author Study arms (number of patients) Study sample Inclusion criteria Exclusion criteria Follow-up (months) Leishmania species characterization (% of patients) Leishmania species Cure criteria used Lost to follow-up
2013, Soto et al. MA intralesional (30), Cryotherapy (20),Placebo cream (30) 80 parasitological diagnosis (smears or biopsy, culture), ≥12 years of age, one ulcerative lesion ≤30 mm2 resulting in a total lesion area of ≤900 mm2 previous anti-leishmanial therapy (< 3 months), mucosal lesions, concomitant diseases 6 42/80 (52.5%) L. braziliensis (36); L. guyanensis (2); L. amazonensis (2); L. lainsoni (2) 100% reepithelialization within 6 months after the end of therapy 3/80 (3.7%)
2004, Soto et al. Miltefosine (89); Placebo (44) 133 parasitological diagnosis (smears, culture, biopsy, monoclonal antibody), ≥12 years of age previous anti-leishmanial therapy (< 4 weeks), mucosal lesions, concomitant diseases, pregnancy, lactation 6 53/133 (39.8%) L braziliensis (29); L mexicana (17); L panamensis (7) 100% reepithelialization within 6 months after the end of therapy 8/133 (6%)
2002, Soto et al. New drug test # (33), Placebo (12) 45 parasitological diagnosis (smears, culture, biopsy, monoclonal antibody), total ulcer lesion size < 2000 mm2, lymphadenopathy < 1 cm severe disease; papular or nodular lesions; mucosal lesions, concomitant diseases 6 5/45 (11.1%) L. panamensis (5) 100% reepithelialization by the 6-month follow-up 8/45 (17.8%)
2001, Arana et al. Paromomycin + MBCL (38), Placebo (38) 76 parasitological diagnosis (smears, culture), age between 10–60 years (smears, culture) > 4 lesions; lesion > 5 cm in diameter; previousanti-leishmanial therapy; mucosal lesions, concomitant diseases 12 not available not available 100% reepithelialization by the 13-week follow-up 8/76 (10.5%)
1997, Neva et al. Topical paromomycin+ urea (23); Placebo (30) 53 parasitological diagnosis (culture) NA 5 53/53 (100%) L. mexicana (18), L. chagasi (35) 100% reepithelialization within 11 weeks after the end of therapy 6/53 (11.3%)
1997, Velez et al. Allopurinol (60), Placebo (56); MA (66) 182 parasitological diagnosis (smears, culture), age between 6–60 years; body weight appropriate for height Previous anti-leishmanial therapy, lesions close to the eyes; mucosal lesions, concomitant diseases, pregnancy 12 not available not available 100% reepithelialization within 3 months after the end of therapy with no relapse by the 12-month follow-up 25/182 (13.7%)
1995, Martha et al. Allopurinol+probenecid (30); SS (30); No therapy (15) 75 parasitological diagnosis (smears, culture, biopsy, monoclonal antibody) mucosal lesions, concomitant diseases 12 26/75 (34.7%) L. panamensis (12); L. guyanensis (7); L. braziliensis (4);L. mexicana (1); L. amazonensis (2) 100% reepithelialization by the 70-day follow-up 13/75 (17.3%)
1993, Soto et al. MA (23); Pentamidine (27), Itraconazole(20); No treatment (22) 92 parasitological diagnosis (smears, culture, biopsy, monoclonal antibody), age between 18–60 years mucosal lesions, concomitant diseases, previous anti-leishmanial therapy 12 not available not available 100% reepithelialization within 1.5 months after the end of therapy 6/92 (6.5%)
1992, Martinez et al. MA (33); Allopurinol+MA (35); Allopurinol (25), No treatment (17) 110 parasitological diagnosis (smears, culture, biopsy); lesions confined to the upper portion of the trunk or arms allergy to antimony or allopurinol; pregnant or nursing, concomitant diseases, more than 20% above or below ideal weight 12 110/110 (100%) L. panamensis (110) 100% reepithelialization and negative culture within 3 months after the end of therapy not available
1992, Navin et al. SS (40); Ketoconazole (38), Placebo (40) 120 parasitological diagnosis (smears, culture), male gender mucosal lesions, concomitant diseases, previous anti-leishmanial therapy 13 97/120 (80.8%) L. mexicana (32); L. braziliensis (63); both L. mexicana and L. braziliensis (2) 100% reepithelialization by the 13-week follow-up 7/120 (5.8%).
1991, Guderian et al. SS (30); Allopurinol+probenecid (30); No treatment (15) 75 parasitological diagnosis (smears, culture, biopsy, monoclonal antibody) mucosal lesions, concomitant diseases, less than 6 months of follow-up 1.5 * 23/75 (30.7%) L. panamensis(12); L. guyanensis (5); L. braziliensis(3); L. mexicana(3) >80% reepithelialization by the 1-month follow-up 14/75 (18.7%).
1990, Navin et al. MA (22); Localized Heat (22); Placebo (22) 66 parasitological diagnosis (smears, culture), lesions<25 cm2 lesions in ear, near the eye, on the finger; presence of unilateral lymphadenopathy; mucosal lesions, concomitant diseases, previous anti-leishmanial therapy 12 53/66 (80.3%) L. mexicana (13); L. braziliensis (40) 100% reepithelialization by the 13-week follow-up 3/66 (4.54%)
1990, Saenz et al. Ketoconazole (22); SS (19); Placebo (11) 52 parasitological diagnosis (smears, culture) facial or mucosal lesions; concomitant disease 3 38/52 (73.1%) L. guyanensis (37); L. mexicana (1) 100% reepithelialization by the 1-month follow-up NA