罗氟司特乳膏有哪些不良反应？

There is a study using 0.5% roflumilast ointment to treat patients with stage I stable chronic plaque psoriasis. The results suggest that topical application can effectively reduce the inflammatory response in patients, but its overall safety and long-term effects have not been effectively observed. Studies have also confirmed that topical roflumilast ointment is significantly better than placebo in clearing skin lesions in patients with stage IIb plaque psoriasis. So, what are the side effects of roflumilast cream?

What are the adverse reactions of roflumilast cream?

In two multicenter, randomized, double-blind, vehicle-controlled trials (DERMIS-1 and DERMIS-2), 881 subjects ≥2 years of age with plaque psoriasis received ZORYVE or vehicle once daily for 8 weeks.

The median age was 47 years (range: 6-88 years). The majority of subjects were male (64%) and white (82%). Median affected body surface area (BSA) was 5.5% (range: 2%-20%).

The rate of discontinuation of treatment as a result was 1.0% of ZORYVE-treated subjects and 1.3% of vehicle-treated subjects. The most common adverse reaction leading to discontinuation of ZORYVE was application site urticaria (0.3%).

Table 1 lists adverse reactions that occurred in at least 1% of subjects treated with ZORYVE and occurred more frequently than in the vehicle group.

Table 1: Adverse reactions reported in ≥1% of subjects treated with ZORYVE for 8 weeks

Among the 594 subjects who continued treatment with ZORYVE for up to 64 weeks in the open-label extension trial, the adverse reaction profile was similar to that observed in the vehicle-controlled trial.

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