Table 2.
Incidence of treatment-emergent adverse events (safety population)
| TEAEs, n (%) | Clobetasol propionate 0.025% cream | Clobetasol propionate 0.05% cream (N = 30) |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Formulation 5 (N = 29) | Formulation 13 (N = 29) | ||||||||
| Total | Treatment related | Probably related | Total | Treatment related | Probably related | Total | Treatment related | Probably related | |
| Patients with at least 1 TEAE | 13 (44.8) | 0 | 12 (41.4) | 15 (50.0) | 0 | 10 (34.5) | 15 (50.0) | 0 | 11 (36.7) |
| TEAEs in > 3% of patients | 0 | 0 | 0 | 0 | 0 | 0 | 2 (6.7) | 0 | 0 |
| Pain | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.3) | 0 | 0 |
| Pyrexia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.3) | 0 | 0 |
| Gastroenteritis | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.3) | 0 | 0 |
| Nasopharyngitis | 0 | 0 | 0 | 0 | 0 | 0 | 2 (6.7) | 0 | 0 |
| Tinea cruris | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.3) | 0 | 0 |
| Blood cortisol decrease | 13 (44.8) | 0 | 12 (41.4) | 11 (37.9) | 0 | 10 (34.5) | 11 (36.7) | 0 | 11 (36.7) |
| Cough | 0 | 0 | 0 | 0 | 0 | 0 | 2 (6.7) | 0 | 0 |
| Pruritus | 1 (3.4) | 0 | 0 | 0 | 0 | 0 | 1 (3.3) | 0 | 0 |
| Telangiectasia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.3) | 0 | 1 (3.3) |
| Mild | Moderate | Severe | Mild | Moderate | Severe | Mild | Moderate | Severe | |
|---|---|---|---|---|---|---|---|---|---|
| Proportion of patients with mild, moderate, and severe | |||||||||
| Patients with at least 1 TEAE | 11 (37.9) | 2 (6.9) | 1 (3.4) | 7 (24.1) | 3 (10.3) | 1 (3.4) | 9 (30.0) | 6 (20.0) | 3 (10.0) |
| Pain | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.3) |
| Pyrexia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.3) | 0 | 0 |
| Gastroenteritis | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.3) | 0 | 0 |
| Nasopharyngitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (6.7) | 0 |
| Tinea cruris | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.3) | 0 | 0 |
| Blood cortisol decrease | 10 (34.5) | 2 (6.9) | 1 (3.4) | 7 (24.1) | 3 (10.3) | 1 (3.4) | 6 (20.0) | 4 (13.3) | 1 (3.3) |
| Hyperglycemia | 1 (3.4) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cough | 0 | 0 | 0 | 0 | 0 | 0 | 2 (6.7) | 0 | 0 |
| Pruritus | 1 (3.4) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.3) |
| Telangiectasia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (3.3) | 0 | 0 |
TEAEs treatment-emergent adverse events.