克立硼罗软膏治疗特应性皮炎的安全性和有效性

Introduction: It is a PDE-4 inhibitor topical ointment that has been confirmed to have good safety by multiple clinical studies. In clinical trials, no significant increase in serious adverse events was reported in the criborole group compared with the placebo group. Criborole is particularly effective in patients with mild to moderate atopic dermatitis and can significantly improve skin symptoms, such as reducing erythema, itching, and skin lesion area.

Drug Introduction

Criborole Ointment is a new drug ointment that was first approved by the U.S. Food and Drug Administration on December 14, 2016. The label indication is for the topical treatment of mild to moderate atopic dermatitis in patients 2 years and older. This is a new topical approach to the treatment of atopic dermatitis (mechanism of action), independent of corticosteroids.

Effectiveness

In the clinical trial leading to the FDA approval of criborole ointment, researchers enrolled 1,522 patients with mild to moderate eczema. Their ages range from 2 to 79 years old. To test the safety and effectiveness of this drug, some patients received criborole ointment. Other patients were given a moisturizing ointment that looked like criborole ointment but did not contain any medication.

After using criborole ointment twice daily for 28 days in these clinical trials, about one-third of the participants had clear or nearly clear skin. Studies have found that criborole ointment relieved itching in more patients than moisturizer. On the second day of the study, 34 percent of patients who used criborole ointment had relief from itching, compared with only 27 percent of those who used moisturizer. At the end of the study, 57% of patients treated with criborole ointment no longer experienced itchy skin, compared with 40% of those treated with moisturizer.

Safety

The most common side effect of criborole ointment is a local skin reaction, with a burning or stinging sensation at the application site, which usually occurs immediately after using criborole ointment. But these are usually mild to moderate and tend to lessen during treatment.

Less than 2% of patients experienced side effects that caused them to stop using the medication, just as many patients who received the moisturizer stopped using it because of side effects. In a long-term 48-week study, researchers found that few patients experienced side effects.