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

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: 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. Results: 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. Conclusion: 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. Trial Registration: Iranian Registry of Clinical Trials (IRCT), IRCT20091012002581N10, registered on October 28, 2023; https://irct.ir/trial/73367.

Source: Psoriasis Targets and Therapy

DOI: 10.2147/ptt.s647017

Authors: Hamed Mamizadeh, Hamideh Herizchi Ghadim, Sajjad Pourasghary

Institution: Tabriz University of Medical Sciences

Language: English

Topic: Psoriasis: Treatment and Pathogenesis

Subfield: Immunology

Field: Immunology and Microbiology

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,320