Table 6. Assessment of changes in number of patient’s symptom grading on 4-point scale between groups.
Changes in symptom grading on 4-point scale (number of patient’s) | |||||||||||||||||
Visits | Visit 1 | Visit 2 | Visit 3 | Visit 4 | |||||||||||||
Score | 0 | 1 | 2 | 3 | 0 | 1 | 2 | 3 | 0 | 1 | 2 | 3 | 0 | 1 | 2 | 3 | |
Symptoms | EnMax | ||||||||||||||||
Erythema | 8 | 8 | 10 | 0 | 13 | 7 | 6 | 0 | 20* | 6 | 0 | 0 | 25* | 1 | 0 | 0 | |
Local irritation | 4 | 14 | 8 | 0 | 10 | 16 | 0 | 0 | 22*# | 4 | 0 | 0 | 24*# | 2 | 0 | 0 | |
Discharge (Pus/blood) | 13 | 12 | 1 | 0 | 24*# | 2 | 0 | 0 | 23*# | 3 | 0 | 0 | 26* | 0 | 0 | 0 | |
Induration | 6 | 11 | 9 | 0 | 12 | 13 | 1 | 0 | 18* | 8 | 0 | 0 | 24* | 2 | 0 | 0 | |
Tenderness | 4 | 15 | 7 | 0 | 17# | 9 | 0 | 0 | 24*# | 2 | 0 | 0 | 25* | 1 | 0 | 0 | |
Placebo | |||||||||||||||||
Erythema | 9 | 13 | 4 | 0 | 9 | 15 | 2 | 0 | 11 | 15 | 0 | 0 | 12 | 14 | 0 | 0 | |
Local irritation | 2 | 17 | 7 | 0 | 4 | 18 | 4 | 0 | 7 | 18 | 1 | 0 | 10 | 16 | 0 | 0 | |
Discharge (Pus/blood) | 11 | 14 | 1 | 0 | 13 | 13 | 0 | 0 | 15 | 11 | 0 | 0 | 18 | 8 | 0 | 0 | |
Induration | 5 | 15 | 6 | 0 | 6 | 18 | 2 | 0 | 10 | 16 | 0 | 0 | 14 | 12 | 0 | 0 | |
Tenderness | 7 | 13 | 6 | 0 | 10 | 15 | 1 | 0 | 11 | 15 | 0 | 0 | 13 | 13 | 0 | 0 | |
Marketed reference | |||||||||||||||||
Erythema | 2 | 8 | 3 | 0 | 4 | 8 | 1 | 0 | 7 | 6 | 0 | 0 | 11 | 2 | 0 | 0 | |
Local irritation | 1 | 9 | 3 | 0 | 3 | 10 | 0 | 0 | 7 | 6 | 0 | 0 | 8 | 5 | 0 | 0 | |
Discharge (Pus/blood) | 7 | 5 | 1 | 0 | 8 | 5 | 0 | 0 | 8 | 5 | 0 | 0 | 12 | 1 | 0 | 0 | |
Induration | 5 | 6 | 2 | 0 | 6 | 5 | 2 | 0 | 7 | 6 | 0 | 0 | 9 | 4 | 0 | 0 | |
Tenderness | 2 | 11 | 0 | 0 | 3 | 10 | 0 | 0 | 6 | 7 | 0 | 0 | 10 | 3 | 0 | 0 |