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Topicort (Desoximetasone Topical) - Side Effects and 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%)

Drug label data at the top of this Page last updated: 2013-04-15

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