Roflumilast Eases Sexual Difficulties in Psoriasis With Genital Involvement

Roflumilast cream 0.3% (Zoryve; Arcutis Biotherapeutics) and roflumilast foam 0.3% improved sexual function, personal relationships, and skin outcomes in patients with plaque psoriasis, including those with genital involvement. The findings come from an analysis of the phase 3 DERMIS-1/2 and ARRECTOR trials, presented as a poster at Fall Clinical 2026 in Las Vegas.

As Payette et al noted, topical corticosteroids (TCS) are not approved for long-term use because of cutaneous and systemic adverse event (AE) risk, and higher-potency TCS are not recommended in thin-skinned areas such as the genitals. Roflumilast is a topical phosphodiesterase 4 (PDE4) inhibitor formulated without ethanol, propylene glycol, or fragrances.¹This analysis adds patient-reported data on sexual function and relationships to the efficacy findings from both trials.¹

DERMIS-1 (NCT04211363) and DERMIS-2 (NCT04211389) were identically designed, randomized, double-blind, vehicle-controlled, 8-week trials of once-daily roflumilast cream 0.3% in patients aged 2 years and older with at least mild plaque psoriasis. ARRECTOR (NCT05028582) tested once-daily roflumilast foam 0.3% in patients aged 12 years and older with at least moderate scalp psoriasis and at least mild body psoriasis. Both programs randomized patients 2:1 to active treatment or vehicle.¹

DERMIS-1/2 included 576 patients in the roflumilast arm and 305 in the vehicle arm, while ARRECTOR included 281 and 151, respectively. Genital involvement was present at baseline in 15.6% of patients in DERMIS-1/2 and 17.4% in ARRECTOR. Mean age was approximately 47 years, and more than 80% of patients were White.¹

In DERMIS-1/2, 39.9% of patients treated with roflumilast cream achieved Investigator Global Assessment (IGA) success at week 8 vs 6.5% with vehicle (P < .0001). Among patients with genital involvement, IGA success was 39.3% vs 5.4% (P < .005). In ARRECTOR, body IGA success reached 45.5% with roflumilast foam vs 20.1% with vehicle (P < .0001), and 45.1% vs 5.7% in the genital involvement subgroup (P < .005).¹

Worst Itch-Numeric Rating Scale (WI-NRS) success was 68.5% vs 31.3% in DERMIS-1/2 (P < .0001) and 63.1% vs 30.1% in ARRECTOR (P < .0001). In the genital subgroups, WI-NRS success was 71.0% vs 16.7% with the cream (P < .005) and 63.6% vs 37.9% with the foam. All analyses used intent-to-treat populations, and P values for the genital involvement subgroups were nominal.¹

Roflumilast Effects on Sexual Function, Relationships, and Tolerability

Quality of life gains followed the same pattern. In DERMIS-1/2, 73.3% (n = 333) of patients treated with roflumilast cream achieved a Dermatology Life Quality Index (DLQI) minimally important difference, defined as a reduction of 4 points or more, vs 40.4% (n = 183) with vehicle (P < .0001). Among patients with genital involvement, the rates were 64.4% (n = 59) vs 34.6% (n = 26) (P < .03).¹

In ARRECTOR, 69.4% (n = 180) of patients using roflumilast foam reached the DLQI minimally important difference vs 36.2% (n = 94) with vehicle (P < .0001). In the genital involvement subgroup, the rates were 81.8% (n = 33) vs 33.3% (n = 18) (P < .005). P values for the genital subgroups were nominal, and analyses covered patients aged 17 years and older with a baseline DLQI of 4 or higher.¹

Patients also rated how much psoriasis caused sexual difficulties and problems with partners, close friends, or relatives on a scale from 0 to 4. At week 8, responses on both items favored roflumilast over vehicle in the overall populations and in patients with genital involvement at baseline.¹

Roflumilast cream and foam were well tolerated regardless of body area involved. Fewer than 1% of patients reported a hot, tingling, or stinging sensation with definite discomfort 10 to 15 minutes after the first application. The safety populations included 562 patients on roflumilast cream, 301 on vehicle cream, 280 on roflumilast foam, and 148 on vehicle foam.¹

The authors concluded the results support both formulations for psoriasis of the body, including in patients with genital involvement who may have impaired sexual function or quality of life. They also advised providers to consider discussing sexual function with patients who have psoriasis and genital involvement.¹ Both trials were previously published in peer-reviewed journals.^2,3

References

1. Payette M, Bhutani T, Young M, et al. Improvements in psoriasis, including sexual function and personal relationships, with roflumilast cream 0.3% and foam 0.3%: outcomes from the phase 3 DERMIS-1/2 and ARRECTOR trials. Presented at: 2026 Fall Clinical Dermatology Conference; October 8–11, 2026; Las Vegas, NV.
2. Lebwohl MG, Kircik LH, Moore AY, et al. Effect of roflumilast cream vs vehicle cream on chronic plaque psoriasis: the DERMIS-1 and DERMIS-2 randomized clinical trials. JAMA. 2022;328(11):1073-1084. doi:10.1001/jama.2022.15632
3. Gooderham MJ, Alonso-Llamazares J, Bagel J, et al. Roflumilast foam, 0.3%, for psoriasis of the scalp and body: the ARRECTOR phase 3 randomized clinical trial. JAMA Dermatol. 2025;161(7):698-706. doi:10.1001/jamadermatol.2025.1136

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