Efficacy and Safety of 5% Topical Caffeine Added to 0.025% Fluocinolone Acetonide Cream for Plaque Psoriasis: A Randomized Controlled Trial.
Mamizadeh Hamed H, Herizchi Ghadim Hamideh H, Pourasghary Sajjad S
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. 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. Baseline PASI scores were comparable between the intervention and control groups (3.41 ± 1.86 vs 3.79 ± 1.51, respectively; P=0.484). PASI scores were significantly lower in the intervention group at each post-treatment assessment. At week 4, mean PASI was 0.39 ± 0.17 in the intervention group and 2.29 ± 1.31 in the control group (P=0.001). The mean reduction from baseline to week 4 was 3.01 ± 1.48 with 5% caffeine plus FAC and 1.49 ± 1.01 with FAC alone (P<0.001). Complete clearance, defined as PASI=0, occurred in 14 of 20 patients (70%) in the intervention group compared with 1 of 20 (5%) in the control group (P=0.001). No adverse events were reported during the study. Adding topical 5% caffeine to FAC produced a greater short-term reduction in psoriasis severity than FAC alone. No adverse events were reported during the 4-week treatment period. Larger randomized trials with longer follow-up are warranted to confirm efficacy and characterize longer-term tolerability. Iranian Registry of Clinical Trials (IRCT), IRCT20091012002581N10, registered on October 28, 2023; https://irct.ir/trial/73367.