Table 2.
Baseline characteristics of the ITT patients enrolled in the three treatment groups of the trial
| Intention to treat (ITT) evaluation | Test | |||||
|---|---|---|---|---|---|---|
| Group I | Group II | Group III | Total | p-value | ||
| Male | 14 | 12 | 15 | 41 | Pearson Chi-Square | |
| Female | 10 | 17 | 13 | 40 | 0.446* | Test (Exact-Sig.) |
| Age (95% CI) | 26 (19-33) | 28 (23-33) | 32 (25-38) | 29 (25-32) | 0.252* | Kruskal-Wallis Test |
| Lesion age (95% CI) | 9 (7-10) | 9 (8-11) | 7 (6-8) | 8 (7-9) | 0.187* | Kruskal-Wallis Test |
| Lesion size (95% CI) | 3.6 (2.3-4.9) | 2.3 (1.7-3.0) | 2.7 (1.8-3.6) | 2.8 (2.3-3.4) | 0.204* | Kruskal-Wallis Test |
| Parasite species | ||||||
| L. major | 5 | 7 | 9 | 21 | ||
| L. tropica | 5 | 14 | 11 | 30 | Pearson Chi-Square | |
| Not determined | 14 | 8 | 8 | 30 | 0.614* | Test (Exact-Sig.) |
| Lesion location | ||||||
| Head | 5 | 4 | 4 | 13 | ||
| Trunc | 0 | 0 | 1 | 1 | ||
| Upper extr. | 12 | 19 | 16 | 47 | Pearson Chi-Square | |
| Lower extr. | 7 | 5 | 7 | 19 | 0.799* | Test (Exact-Sig.) |
| Parasite load according to Giemsa staining | ||||||
| Low (+) | 13 | 16 | 11 | 40 | ||
| Moderate (++) | 8 | 13 | 16 | 37 | ||
| High (+++) | 1 | 0 | 1 | 2 | Pearson Chi-Square | |
| Not determined | 2 | 0 | 0 | 2 | 0.534* | Test (Exact-Sig.) |
| Biopsy prior to treatment | ||||||
| Evaluable | 17 | 23 | 22 | 62 | Pearson Chi-Square | |
| Not evaluable | 7 | 6 | 6 | 19 | 0.800* | Test (Exact-Sig.) |
| Parasite load/g tissue (SEM) | 2.773 (1.554)x106 | 3.430 (1.736)x106 | 2.368 (1.526)x106 | 2.889 (0.932)x106 | 0.691* | Kruskal-Wallis Test |
Statistical tests were used as indicated (p < 0.05 indicates a significant proportion, * p-values refer to observations with complete information).