罗氟司特乳膏是激素类药物吗？

It is not a hormonal drug. The ingredients of this drug do not contain hormones and will not cause dependence on the human body.

Roflumilast cream drug ingredients

The active ingredient in roflumilast cream is roflumilast. The inactive ingredients are cetearyl 10 phosphate, cetearyl phosphate, cetearyl alcohol, diethylene glycol monoethyl ether, hexylene glycol, isopropyl palmitate, methyl paraben, propyl paraben, purified water, sodium hydroxide and white petrolatum. Hydrochloric acid can be added to adjust the pH value.

Common medications

Roflumilast cream can cause side effects such as diarrhea, pain at the application site, headache, upper respiratory tract infection, difficulty sleeping, urinary tract infection, and nausea during treatment.

If the patient experiences the above adverse reactions during treatment and is more serious, such as frequent diarrhea, severe headache, etc., the patient should consult a doctor in time and determine whether it is necessary to reduce the drug dose or stop taking the drug under the doctor's evaluation.

Mechanism of action

Roflumilast and its active metabolite (roflumilast N-oxide) are inhibitors of PDE4. Roflumilast and roflumilast N-oxide inhibit the activity of PDE4, a major cyclic adenosine 3′,5′-monophosphate (cAMP) metabolizing enzyme, resulting in intracellular accumulation of cyclic AMP. The specific mechanism by which roflumilast exerts its therapeutic effect is unclear.

Roflumilast cream has a good therapeutic effect on plaque psoriasis. It can relieve patients' itching symptoms and improve their skin condition.

Two multicenter, randomized, double-blind, vehicle-controlled trials (DERMIS-1 [NCT04211363] and DERMIS-2 [NCT04211389]) enrolled a total of 881 subjects with mild to severe plaque psoriasis and BSA involvement of 2%-20%. The age range of the study population was 6-88 years, with 4 subjects younger than 12 years old at baseline. At baseline, 16% of subjects had an Investigator's Global Assessment (IGA) score of 2 (mild), 76% had an IGA score of 3 (moderate), and 8% had an IGA score of 4 (severe). 179 (20%) subjects had a baseline intertrigo IGA (I-IGA) score of 2 or higher (mild), and 678 (77%) subjects had a baseline worst itching numeric rating scale (WI-NRS) score of 4 or higher (0-10 scale).

The results showed that among subjects with a baseline I-IGA score of at least 2 (mild) (approximately 22% of subjects in DERMIS-1 and approximately 19% of subjects in DERMIS-2), the percentage of subjects who achieved I-IGA success at week 8 was higher in the ZORYVE group than in the vehicle group (DERMIS-1: 71.5% vs. 13.8%; DERMIS-2: 67.5% vs. 17.4%).

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