Efficacy and Safety of 5% Topical Caffeine Added to 0.025% Fluocinolone Acetonide Cream for Plaque Psoriasis: A Randomized Controlled Trial

Purpose

To evaluate whether adding topical 5% caffeine to fluocinolone acetonide 0.025% cream (FAC) improves short-term clinical outcomes compared with FAC alone in patients with chronic plaque psoriasis. Patients and methods: This randomized, parallel-group, masked, active-controlled clinical trial included 40 patients with chronic plaque psoriasis treated at the dermatology outpatient clinic of Sina Hospital, Tabriz, Iran. Participants were randomly allocated in a 1:1 ratio to receive either topical 5% caffeine plus fluocinolone acetonide 0.025% (intervention group, n=20) or topical fluocinolone acetonide 0.025% alone (control group, n=20). Psoriasis severity was assessed using the Psoriasis Area and Severity Index (PASI) at baseline and weekly for four weeks. Treatment response and adverse events were also recorded.