ADVERSE REACTIONS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate to severe plaque psoriasis of the body applied Topicort® Topical Spray or vehicle spray twice daily for 4 weeks. A total of 149 subjects applied Topicort® Topical Spray.
Adverse reactions that occurred in ≥ 1% of subjects treated with Topicort® Topical Spray were application site dryness (2.7%), application site irritation (2.7%) and application site pruritus (2.0%).
Another less common adverse reaction (<1% but >0.1%) was folliculitis.
Table 1. Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1%
|
Topicort® Topical Spray, 0.25% b.i.d.
(N = 149) |
Vehicle spray b.i.d.
(N = 135) |
| Number of Subjects with Adverse Reactions |
13 (8.7%) |
18 (13.3%) |
| Application site dryness |
4 (2.7%) |
7 (5.2%) |
| Application site irritation |
4 (2.7%) |
5 (3.7%) |
| Application site pruritus |
3 (2.0%) |
5 (3.7%) |
|
