Table 1. Baseline Characteristics of the Participants.
WR279,396 (N = 50) | Placebo-Vehicle (N = 42) | P Value | |
Center – no. (%) | |||
Paris, France | 5 (10) | 5 (12) | 1.0 |
Sidi Bouzid, Tunisia | 45 (90) | 37 (88) | |
Male sex – no. (%) | 27 (54) | 27 (64) | 0.40 |
Age <18 years – no. (%) | |||
Overall | 47 (94) | 33 (79) | 0.034 |
Paris, France (N = 10) | 2 (40) | 0 (0) | |
Sidi Bouzid, Tunisia (N = 82) | 45 (100) | 33 (89) | |
Lesions – no. (%) | |||
1 | 28 (56) | 26 (62) | 0.67† |
2 | 9 (18) | 7 (17) | |
3 | 9 (18) | 4 (10) | |
4 or 5 | 4 (8) | 5 (12) | |
Total lesion area – mm2 | |||
Median | 128 | 154 | 0.52 |
Interquartile range | 85 to 223 | 70 to 264 | |
Index lesion area – mm2 | |||
Median | 92 | 115 | 0.34 |
Interquartile range | 55 to 141 | 50 to 172 | |
Index lesion on upper body – no. (%) | 20 (40) | 17 (40) | 1.0 |
Index lesion on extremity – no. (%) | 48 (96) | 42 (100) | 0.50 |
Days before treatment since lesion first noticed | |||
Median | 62 | 62 | 0.96 |
Interquartile range | 38 to 79 | 39 to 79 | |
Leishmania species – no. (%) | |||
L. major | 32* (64) | 24* (57) | 0.53‡ |
L. infantum | 1 (2) | 0 (0) | |
L. tropica | 1 (2) | 0 (0) | |
Unidentified | 16 (32) | 18 (43) |
Comparisons of categorical variables use the Fisher's exact test for the entire study cohort, while comparisons of continuous variables use the Wilcoxon rank-sum test.
†: Compares the proportion of participants in each group with a sole lesion at baseline.
*: Species identification was by isoenzyme electrophoresis (18 isolates), PCR (50 isolates) or both techniques (8 isolates). All isolates identified by both techniques were from Tunisia and all belonged to the L. major MON-25 zymodem (the only L. major zymodem reported from the Maghreb). In France, identification was by isoenzyme electrophoresis in 8 cases as follows: L. major MON-25 (5 isolates), L. infantum MON-24, L. major MON-26, L. major MON-74 (1 isolate each).
‡: Compares the proportion of participants in each group with L. major identified.