|
| Visit 2 (2) | Visit 3 (3) | End of study (4) | p value (Overall) |
| Healing and reduction of manifestations |
|
|
|
|
| None | 0 | 0 | 1 (1.8%) |
|
| Partial | 47 (83.9%) | 22 (39.3%) | 22 (39.3%) |
|
| Total | 9 (16.1%) | 34 (60.7%) | 33 (58.9%) |
|
| Total reduction of manifestations | 10 (17.9%)3,4 | 34 (60.7%)2 | 32 (57.1%)2 | <0.001d |
| Adverse effects (n = 58 patients) | 3 (5.2%) | 0 | 0 | 0.368d |
| Tolerability by investigator |
|
|
| 0.097 c |
| Very good | 51 (87.9%)4a | 53 (94.6%) | 54 (96.4%)2a |
|
| Good | 5 (8.6%) | 3 (5.4%) | 2 (3.6%) |
|
| Satisfactory | 1 (1.7%) | 0 | 0 |
|
| Moderate improvement | 1 (1.7%) | 0 | 0 |
|
| Aggravation | 0 | 0 | 0 |
|
| Tolerability by patient |
|
|
| 0.097 c |
| Very good | 52 (89.7%)4a | 55 (98.2%) | 54 (96.4%)2a |
|
| Good | 4 (6.9%) | 1 (1.8%) | 2 (3.6%) |
|
| Satisfactory | 2 (3.4%) | 0 | 0 |
|
| Moderate improvement | 0 | 0 | 0 |
|
| Aggravation | 0 | 0 | 0 |
|
| Th success by investigator |
|
|
| <0.001 c |
| Excellent | 24 (42.9%)3,4 | 44 (78.6%)2,4a | 35 (62.5%)2,3a |
|
| Very good | 27 (48.2%) | 8 (14.3%) | 12 (21.4%) |
|
| Good | 5 (8.9%) | 4 (7.1%) | 8 (14.3%) |
|
| Intolerance | 0 | 0 | 1 (1.8%) |
|
| Th success by patient |
|
|
| <0.001 c |
| Excellent | 26 (46.4%)3,4 | 44 (78.6%)2 | 37 (66.4%)2 |
|
| Very good | 26 (46.4%) | 9 (16.1%) | 13 (23.2%) |
|
| Good | 4 (7.1%) | 3 (5.4%) | 5 (8.9%) |
|
| Intolerance | 0 | 0 | 1 (1.8%) |
|