Efficacy and safety of a topical moisturizer containing linoleic acid and ceramide for mild-to-moderate psoriasis vulgaris: A multicenter randomized controlled trial

Abstract

Psoriasis is a chronic, recurrent skin disease requiring long-term management. Agents that repair the skin's barrier function are invaluable additives in topical treatments of psoriasis. This multicenter, randomized, controlled trial evaluated the efficacy and safety of a linoleic acid-ceramide-containing moisturizer (LA-Cer) for mild-to-moderate psoriasis vulgaris. We randomized 178 patients from both northern and southern regions of China into two groups: 81 patients in the control group received mometasone furoate (MF, 0.1%) cream, while MF in combination with LA-Cer was administered to 86 patients in the treatment group for 4 weeks. The LA-Cer-MF group maintained the use of moisturizer after topical glucocorticoid administration. The primary endpoint, Psoriasis Area and Severity Index 50 (PASI 50) response, revealed the superiority of LA-Cer-MF with lower relapse rates at week 8. The use of the LA-Cer-containing moisturizer as maintenance therapy resulted in a continuous improvement in the clinical state in terms of body surface area, PASI, investigators' assessment of skin dryness and desquamation, and Physician Global Assessment of Psoriasis score, and in the patients' quality of life. Thus, the LA-Cer-containing moisturizer is a promising agent to prevent and treat psoriasis as it enhances the therapeutic effect induced by topical glucocorticoids and delays relapse.

Keywords: ceramide; linoleic acid; moisturizer; psoriasis; relapse; skin barrier.

FIGURE 1

Flow diagram of the RCT. 167 patients underwent randomization to MF or La‐Cer‐MF with a 1:1 ratio. *Patients could have one or several major deviation(s)

FIGURE 2

Comparison of PASI improvement between patients treated with or without LA‐Cer moisturizer Graph A, and B, represent PASI improvement and PASI score. Observed clinical response rate was shown as the percentage of patients achieving PASI 50, C, and PASI 75, D, in FAS (Full analysis set). Results are expressed as mean ± SD. n = 75 for MF group, n = 83 for LA‐Cer‐MF group. *Represent the significance differences (P < .05) compared with Week 4; #Represent the significance differences (P < .05) between two groups

FIGURE 3

Comparison of clinical assessment between patients treated with or without LA‐Cer moisturizer. Graphs, A‐D, represent BSA, PGA, VAS dryness and desquamation and DLQI, respectively. n = 75 for MF group, n = 83 for LA‐Cer + MF group. Results are expressed as mean ± SD. *Represent the significance differences (P < .05) compared with Week 4; #Represent the significance differences (P < .05) between two groups