A Randomized Controlled Study of the Efficacy of a Topical Antifungal, Antimicrobial, Anti-Inflammatory, and Antiseborrheic Cream in Treating Mild to Moderate Facial Seborrheic Dermatitis

Abstract

Seborrheic dermatitis (SD) presents treatment challenges due to its complex pathogenesis. A nonsteroidal cream (NSC) with antifungal, antimicrobial, anti-inflammatory, and antiseborrheic properties containing piloctone olamine, biosaccharide gum-2, stearyl glycyrrhetinate, and zinc PCA has shown promise in previous studies with the design that lacked control groups and demographic diversity. To validate its efficacy, this randomized, assessor-blinded, controlled trial included 50 Thai subjects with mild-to-moderate facial SD. Participants were randomized 1:1 to apply either NSC or a hydrophilic cream (control) twice daily for 8 weeks. Assessments at week (W) 0, 4, 8, and 12 (4 weeks posttreatment) included severity scores (mSDASI), Investigator Global Assessment (IGA), pruritus, and skin biophysics (erythema index, hydration, TEWL, and sebum levels). The use of triamcinolone acetonide 0.02% cream as rescue medication was recorded. Both NSC (n = 25) and control (n = 25) groups showed clinical improvement from W4, peaking at W8 and continuing to W12. The NSC group’s mSDASI significantly differed from controls at W8 (p = 0.043). The proportion of subjects achieving successful IGA (> 80% improvement) was significantly higher in the NSC group at W8 (44% vs. 16%, p = 0.048). NSC also significantly reduced erythema index at all visits and sebum levels at W4, with lower trends toward pruritus and rescue medication use during treatment. No adverse effects were reported. Overall, NSC demonstrated positive therapeutic effects for mild to moderate facial SD in Southeast Asians, highlighting its potential as a treatment option.

Trail Registration: Thai Clinical Trials Registry: TCTR20230811003