Table 1.
Baseline characteristics of clinical trials included in the analysis of combinations for the treatment of tegumentary leishmaniasis.
| Study source | Area, Country | Study design | Period of study | Age range, mean (years) | Gender | Clinical form | Patients enrolled | Leishmaniasis diagnosis | Statistics |
|---|---|---|---|---|---|---|---|---|---|
| Almeida et al., 2005 | Bahia, Brazil | Open-label clinical trial |
NR | 14-25, 18 | Male 60% Female 40% |
Cutaneous | 5 | Clinical and Laboratory (skin test, and isolation in culture) | No |
|
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| Arevalo et al., 2007 | Lima, Peru | Comparative study; Randomized Controlled Trial |
8/2005–10/2005 | 18-87, 34.9 | Male 55% Female 45% |
Cutaneous | 20 | Clinical and Laboratory (microscopy, culture, and/or PCR, and Montenegro skin test) | Yes |
|
| |||||||||
| Brito et al., 2017 | Bahia, Brazil | Randomized -controlled trial | 12/2010–10/2013 | 18-62 | Predominance of male |
Cutaneous | 162 | Clinical and laboratorial (Leishmania skin test, and/or histopathology, culture and PCR) | Yes |
|
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| El-Sayed & Anwar, 2010 | Sanaa, Yemen | Comparative study; Randomized Controlled Trial |
6/2006–6/2007 | 12-50, 23.5 | Male 53.3% Female 46.7% |
Cutaneous | 30 | Clinical and Laboratory (smear for amastigote and tissue culture) | Yes |
|
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| Farajzafeh et al., 2015 | Iran | Randomized clinical trial | 2011-2012 | 2-60, 18.52 | Male 34 Female 36 NR 10 |
Cutaneous | 80 | Laboratory (smear microscopy) | Yes |
|
| |||||||||
| Firooz et al., 2006 | Razavi, Iran | Multicenter Study; Randomized Controlled Trial |
8/2004-/2005 | 12-60, 27.0 | Male 44.5% Female 55.5% |
Cutaneous | 119 | Laboratory (smear or culture) | Yes |
|
| |||||||||
| Khatami et al., 2013 | Kashan, Iran | Randomized Controlled Clinical Trial | 9/200–4/2010 | 12-60, 28.8 | Male 47% Female 53% |
Cutaneous | 83 | Laboratory (smear or culture) | Yes |
|
| |||||||||
| Llanos Cuentas et al., 2010 | Cusco, Peru | Randomized Controlled Trial | 8/2004 – 6/2005 | 18-59 | Male 96% Female 4% |
Mucosal | 48 | Laboratory (microscopy, PCR or in vitro culture) | Yes |
|
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| Machado et al., 2007 | Bahia, Brazil | Randomized Controlled Trial | NR | 18-65 | Male 83% Female 17% |
Mucosal | 23 | Laboratory (Intradermal skin test, parasite isolation by culture, and/or histopathological) | Yes |
|
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| Meymandi et al., 2011 | Kerman, Iran | Comparative Study; Randomized Controlled Trial |
11/2007-8/2009 | 7-60 | Male 46.6% Female 53.4% |
Cutaneous | 191 | Laboratory (smear or skin biopsy) | Yes |
|
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| Miranda-Verastegui et al., 2005 | Lima, Peru | Randomized Controlled Trial | 2/2001 – 8/2002 | 1-78 | Male 57.5% Female 42.5% |
Cutaneous | 40 | Laboratory (aspiration, smear, biopsy, culture, and/or PCR) | Yes |
|
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| Miranda-Verastegui et al., 2009 | Lima and Cusco, Peru | Comparative Study; Randomized Controlled Trial |
12/2005-6/2006 | 4-52 | Male 77.5% Female 22.5% |
Cutaneous | 80 | Laboratory (smear microscopy, culture or PCR) | Yes |
|
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| Nascimento et al., 2010 | Minas Gerais, Brazil | Randomized Controlled Trial | 10/2004–10/2006 | 18-59, 26.4 | Male 63.6% Female 36.4% |
Cutaneous | 44 | Laboratory (microscopy identification in biopsied tissue) | Yes |
|
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| Nilforoushzadeh et al., 2007 | Isfahan, Iran | Randomized Controlled Trial | NR | 7-70 | Male 67.7% Female 32.3% |
Cutaneous | 90 | Laboratory (smear microscopy) | Yes |
|
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| Nilforoushzadeh et al., 2008 | Tehran, Iran | Comparative Study; Randomized Controlled Trial | NR | 7-70 | Male 71.0% Female 29.0% |
Cutaneous | 124 | Laboratory (smear microscopy) | Yes |
|
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| Van Thiel et al., 2010 | Northern Afghanistan, | Clinical Trial | 6/2005-11/2005 | NR | Dutch Troops |
Cutaneous | 163 | Laboratory (smear microscopy, culture, and PCR) | Yes |
NR, not reported; PCR, polymerase chain reaction.