Table 2. Main methodological characteristics of the New World leishmaniasis studies.
| Year, Author | Country (cases) | Study arms (number of patients) | Prospective/Comparative | Randomized | Inclusion criteria | Exclusion criteria | Cure criteria for ulcered lesions | Follow-up (months) |
|---|---|---|---|---|---|---|---|---|
| 2016,da Silva | Brazil (31) | MA-IL (31) | No/No | No | Parasitologically confirmed diagnosis, patients presenting relapse or not treated disease or contraindication or toxicity with systemic use of MA | NR | Complete re-epithelialization of the ulcer, without any induration of the lesion site | NR |
| 2016,Soto A | Bolivian (90) | SSG 3-IL (30) | Yes/Yes | Yes | Either gender, > 12 years, parasitologically confirmed diagnosis, no previous antileishmanial therapy, no mucosal lesions, no history of concomitant diseases | NR | No doubling in size at 1 month, at least 50% diminution in size at 3 months, and complete re-epithelialization at 6 months | 6 |
| SSG 5-IL (30) | ||||||||
| Penta120-IL (30) | ||||||||
| 2016,Soto B | Bolivian (60) | SSG 5-IL (30) | Yes/Yes | Yes | Either gender, > 12 years, parasitologically confirmed diagnosis, no previous antileishmanial therapy, no mucosal lesions, and no history of concomitant diseases | NR | No doubling in size at 1 month, at least 50% diminution in size at 3 months, and complete re-epithelialization at 6 months. | 6 |
| Penta 240-3-IL (30) | ||||||||
| 2013,Soto | Bolivian (80) | MA-IL (30) | Yes/Yes | Yes | Parasitologically confirmed diagnosis, > 12 years, one ulcerative lesion, lesion area < 900 mm2 | Previous antileishmanial therapy (< 3 months), mucosal lesions, concomitant diseases | No doubling in size at 1 month, at least 50% diminution in size at 3 months, and complete re-epithelialization at 6 months. | 6 |
| Cryo (20) | ||||||||
| placebo cream (30) | ||||||||
| 2012,Vasconcellos | Brazil (24) | MA-IL (24) | No/No | No | Parasitologically confirmed diagnosis, no previous antileishmanial therapy, and presence of contraindication to systemic use of MA | NR | Complete re-epithelialization | 12 |
| 1997, Oliveira-Neto | Brazil (74) | MA-IL (74) | Yes/No | No | Parasitologically confirmed diagnosis, single or few ulcerative lesions and presence of contraindication to systemic use of MA | NR | Complete re-epithelialization and no reactivation of lesions or development of mucosal lesions during follow-up. | >24 |
| 1995,Yépez, | Venezuela (89) | MA-IL (30) | Yes/Yes | No | NR | Facial or digital lesions, secondary infections with satellite adenopathy | Lesion showed a scar | 12 |
| MA-IL+ lidocaine (29) | ||||||||
| lidocaine (30) | ||||||||
| 1995, Gadelha | Brazil (64) | MA-IL (64) | Yes/No | No | Single or few and small lesions in patients presenting relapse or lesions not cured with MA and/or pentamidine | NR | NR | NR |
NR: no reported Cryo: Cryotherapy MA-IL: intralesional meglumine antimoniate Penta120-IL: intralesional pentamidine (120 mg/mm2 of lesion area) for 3 injections Penta 240-3-IL: intralesional pentamidine (240 mg/mm2 of lesion area) in 3 injections SSG-IL: intralesional sodium stibogluconate SSG 3-IL: intralesional sodium stibogluconate for 3 injections SSG 5-IL: intralesional sodium stibogluconate in 5 injections