Adjunctive Efficacy of a Ceramide-Containing Repair and Moisturizing Cream in the Management of Mild-to-Moderate Plaque Psoriasis

We tested whether adding a ceramide-containing moisturizer to topical calcipotriol improves barrier function, quality of life, and clinical outcomes in adults with mild-to-moderate plaque psoriasis. In this single-center, randomized (1:1), parallel-group trial, 80 adults received topical calcipotriol with (intervention group) or without (control group) a ceramide-containing repair and moisturizing cream for 56 days. The sole primary efficacy endpoint was change from baseline in the Psoriasis Area and Severity Index (PASI) score at day 56 following treatment initiation. Secondary and exploratory outcomes included Physician's Global Assessment (PGA) of disease activity, regional PASI, transepidermal water loss (TEWL), water content of the stratum corneum (WCSC), Dermatology Life Quality Index (DLQI) score, Patient Global Assessment (PtGA), and tolerability. Of the 80 randomized participants in the study, 70 completed the scheduled follow-up, of whom 65 were included in the full analysis set (FAS) and 64 included in the per-protocol set (PPS). Change in PASI score at the prespecified day 56 did not differ between the groups in the FAS with last observation carried forward (LOCF) (− 2.41 ± 1.31 [intervention group] vs − 2.18 ± 2.23 [control group]; p = 0.948), and observed-case FAS and PPS sensitivity analyses were consistent with this result. PASI 75 (≥ 75% reduction in PASI score from baseline) response rates were numerically higher in the intervention group but were not statistically significant from those in the control group. Secondary/exploratory analyses showed a greater change at day 56 in the PGA (FAS nominal p = 0.034; PPS nominal p = 0.032), an earlier TEWL signal at day 7 (FAS nominal p = 0.035; PPS nominal p = 0.043), and greater change in the WCSC at day 56 in the FAS (nominal p = 0.039), although the WCSC comparison in the PPS was not significant ( p = 0.056). Change in the DLQI favored the intervention at days 7 and 28 (nominal p = 0.013 and 0.011), but not at day 56. Adjunctive ceramide moisturizer did not significantly improve the primary total PASI endpoint versus calcipotriol alone, but it was associated with greater improvement in the PGA and earlier secondary improvements in barrier function and quality of life. Chinese Clinical Trial Registry ID: ChiCTR2200063795; registered 16 September 2022.