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NEW YORK CITY -- A topical phosphodiesterase-4 (PDE4) inhibitor produced rapid improvement in seborrheic dermatitis, particularly scalp lesions, a randomized clinical trial showed.

Two-thirds of patients randomized to roflumilast 0.3% foam had significant improvement in affected body surface area (BSA) after 8 weeks as compared with fewer than 30% in a control group. A similar proportion of roflumilast-treated patients had at least a 4-point improvement in pruritus score, and about 80% of patients treated with the PDE4 inhibitor reported noticeable improvement in itch by week 2.

Treatment-related adverse events occurred infrequently with roflumilast (1.9% vs 4.2% with the vehicle control), Matthew Zirwas, MD, of Dermatologists of Central States in Bexley, Ohio, reported here during the Inflammatory Skin Disease Summit.

"This is an important phase II, eight-week study," said Zirwas. "The efficacy and safety with roflumilast 0.3% foam for seborrheic dermatitis (included) improvements in IGA (Investigator Global Assessment) that were statistically significant at week 2 and continued to improve through week 8 with a wonderful safety profile, showing very low rates of irritation, local pain, burning, or stinging."

Concentrating in areas with abundant sebaceous glands, seborrheic dermatitis lesions include erythematous scaly plaques that have a yellowish, oily, moist, or greasy appearance, Zirwas noted. The condition can have a negative impact on quality of life, particularly in severe forms of the disease. Standard treatments include antifungals, steroids, immunomodulators, and shampoos, which provide varying degrees of relief. Efficacious and safe options are needed, especially for long-term use, he said.

Roflumilast is a selective PDE4 inhibitor being investigated as a once-daily nonsteroidal therapy for several dermatologic conditions, including seborrheic dermatitis. Zirwas reported initial findings from a phase II trial to evaluate the 8-week safety and efficacy of roflumilast 0.3% foam in patients with at least moderate seborrheic dermatitis (IGA ≥3) with BSA ≤20%.

Investigators in the multicenter trial randomized 226 patients 2:1 to roflumilast or vehicle control. The primary endpoint was IGA success at week 8 (clear or almost clear with ≥2-grade improvement from baseline). Secondary endpoints included overall assessment of erythema and scaling and change in Worst Itch Numeric Rating Scale (WI-NRS).

More than 90% of patients in each group completed the study. Fewer than 2% of patients discontinued because of adverse events.

The study population had a mean age of about 45 with equivalent distribution between men and women. Most of the participants were white (82%), while 10% were Black. Patients had a mean BSA of 3.2%; 93% had a baseline IGA of 3, 89% had moderate erythema, and 81% had a baseline WI-NRS ≥4. More than 60% of the patients had facial involvement.

At week 8, 35.5% of patients treated with roflumilast had IGA scores of 0 (clear) versus 15.2% of the control group. About 70% of patients in the roflumilast group had clear or nearly clear IGA ratings, as compared with about 40% of the control group (P<0.0001). Significantly more patients in the roflumilast group met response criteria by week 2 (P=0.0033).

Erythema scores differed significantly at week 2 (P=0.0065) and continued to increase in favor of roflumilast to week 8 (44.7% vs 21.2%, P=0.0021). Improvement in scaling reached statistical significance at week 4 and increased in favor of roflumilast to week 8 (56.0% vs 27.3%, P=0.0003). More than twice as many patients in the roflumilast arm had at least a 4-point improvement in WI-NRS by week 2 (52.8% vs 23.2%, P=0.0007), and the difference was maintained to week 8 (64.6% vs 34.0%, P<0.0007).

Change in BSA from baseline averaged 66.6% in the roflumilast arm and 28.5% in the control group. The change in BSA was associated with significant improvement in disease-related quality of life by week 4 (P=0.0218), which was maintained to week 8 (P=0.0380).

Incidence of treatment-emergent adverse events (TEAEs) was 24% in the roflumilast arm and 18.1% in the control group. Neither group had any serious events. The most common TEAEs in the roflumilast arm were contact dermatitis, insomnia, and nasopharyngitis (1.9% each).

During a discussion that followed the presentation, session moderator Emma Guttman-Yassky, MD, PhD, of the Icahn School of Medicine at Mount Sinai in New York City, noted that patients had a high itch score, which contrasted with perceptions that seborrheic dermatitis is not so itchy.

"It was predominately itch in the scalp, and that's one of the exciting subanalyses we'll eventually be doing, trying to get more data on the dichotomy between scalp disease and facial disease, because I agree that completely facial disease is essentially not itchy to a significant extent," said Zirwas. "The scalp disease was very itchy, and that will be one of the secondary analyses, looking at that dichotomy."

An unidentified member of the audience asked about the frequency of disease flare after discontinuation of roflumilast. Noting that the trial did not include extended follow-up, Zirwas said, "As someone who took care of these patients, there really wasn't any kind of flare afterwards. The majority of patients transitioned to existing treatments, but I really haven't seen any flaring."

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