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Roflumilast cream can treat seborrheic dermatitis. Roflumilast cream has anti-inflammatory properties and can reduce inflammation and skin irritation symptoms associated with seborrheic dermatitis, such as erythema, scale, and itching. If you need to take medication, you should follow your doctor's instructions carefully.

Marketing approval information

On July 29, 2022, the US FDA approved the marketing of roflumilast cream for the treatment of plaque psoriasis in patients over 12 years old.

On October 6, 2023, the US FDA has approved the supplemental new drug application for roflumilast cream for the topical treatment of plaque psoriasis in children aged 6-11 years.

On December 15, 2023, the U.S. Food and Drug Administration (FDA) approved it for the treatment of seborrheic dermatitis in adults and pediatric patients 9 years and older.

Can Roflumilast Cream Treat Seborrheic Dermatitis

Roflumilast Cream has been shown to be effective in reducing symptoms of inflammation, redness and scaling in people with seborrheic dermatitis, and with its unique formula, Roflumilast Cream can effectively deliver the drug without disrupting the skin barrier and has been shown to be safe and tolerable.

Study results showed that 79.5% of seborrheic dermatitis patients treated with roflumilast cream achieved IGA success at week 8, while only 58% of patients treated with vehicle foam achieved success. Roflumilast cream can not only treat plaque psoriasis in patients 6 years and older, but also treat seborrheic dermatitis in patients 9 years and older.

What is seborrheic dermatitis

Seborrheic dermatitis is a common, chronic, relapsing inflammatory skin disease that causes red patches covered with large, greasy, flaky yellow-gray scales, accompanied by persistent itching. In people with darker skin tones, the inflamed areas may not appear red, but may appear pink, light purple, or lighter than the surrounding skin. They often occur in areas of the body with sebaceous glands, including the scalp, face, upper chest, and back.

Effects of Roflumilast Cream in the Treatment of Seborrheic Dermatitis

Roflumilast Cream rapidly cleared the disease and significantly reduced itching. In the STRATUM trial, nearly 80% of individuals met the primary efficacy endpoint of IGA Success, with just over 50% achieving complete clearance at week 8.

Roflumilast cream was studied in two clinical trials in 683 patients with moderate to severe seborrheic dermatitis, 458 of whom used roflumilast cream and 225 who applied vehicle (foam without active ingredients) to the affected area for 8 weeks.

In clinical trials, after eight weeks of treatment with roflumilast cream, 77% of people had clear or nearly clear skin, compared with 53% of people who used vehicle. At week 8, 63% of 206 people experienced significant relief from itch, compared with 41% of 98 people using vehicle.

Specific usage of roflumilast cream

1. Shake the jar well before each use.

2. Turn the jar upside down and pour a small amount of foam into your hands.

3. Apply a thin layer of foam to all affected areas of skin and scalp, rubbing into skin completely.

4. Be sure to wash your hands thoroughly when using roflumilast cream.

Safety of Roflumilast Cream

Roflumilast Cream was well tolerated, with a favorable safety profile and a tolerability profile for up to 52 weeks of treatment. The incidence of treatment-emergent adverse events (TEAEs) was low and similar between active treatment and vehicle, with most adverse reactions assessed as mild to moderate in severity and no treatment-related serious adverse events occurred. Overall, the most common adverse reactions occurring in ≥1% of subjects in the combined Phase 2 and 3 study populations were nasopharyngitis, nausea, diarrhea, and headache.

Summary

Patients with seborrheic dermatitis should follow the recommended dosage and usage instructions on the drug instructions during treatment with roflumilast cream. In daily life, they should reduce the intake of foods heavy in fats, polysaccharides, spicy, irritating, and heavy salts, wear loose, soft clothing, reduce skin friction, and pay attention to sun protection to protect the skin.

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