Psori Silk in Mild to Moderate Psoriasis: A Randomized Phase I-II Trial Study.

Abstract

In patients with mild to moderate psoriasis, topical corticosteroids are usually the first-line of treatment; however, they are not suitable for long-term use. The purpose of this study was to assess the efficacy and safety of a multi-fruit-and-vegetable compound, Psori Silk, in the treatment of patients with psoriasis. This was a randomized double-blind trial comprising 12 weeks of treatment with Psori Silk versus a vehicle, and a 4-week follow-up. The primary endpoint was 50% reduction in the modified Psoriasis Area and Severity Index (MPASI 50) score at week 12, while the secondary endpoint was quality of life assessment using the Dermatology Life Quality Index (DLQI). The Psori Silk group consisted of 23 patients with 34 lesions to be treated versus 22 patients in the vehicle group with 36 lesions. The MPASI 50 score was observed in 59% patients in the active group versus 22.7% patients in the vehicle group (P < 0.001). A mean 33% DLQI improvement was observed in 65.2% patients in the active group versus 27.2% patients in the vehicle group (P < 0.001). Mild and temporary discomfort at the site of application was reported in 39% patients in the active group versus 23% patients in the vehicle group. Psori silk appears to be an effective and safe treatment option for mild to moderate plaque psoriasis.