Efficacy and Safety of 5% Topical Caffeine Added to 0.025% Fluocinolone Acetonide Cream for Plaque Psoriasis: A Randomized Controlled Trial.
- 1Department of Dermatology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.
- 2Department of Dermatology, Sina Medical Research and Training Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.
- 3Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
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.
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BibTeX
@article{mamizadeh2026efficacy,
title = {{Efficacy and Safety of 5% Topical Caffeine Added to 0.025% Fluocinolone Acetonide Cream for Plaque Psoriasis: A Randomized Controlled Trial.}},
author = {Hamed Mamizadeh and Hamideh Herizchi Ghadim and Sajjad Pourasghary},
journal = {Psoriasis (Auckland, N.Z.)},
year = {2026},
month = oct,
doi = {10.2147/ptt.s647017},
url = {https://europepmc.org/article/MED/42928804},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Efficacy and Safety of 5% Topical Caffeine Added to 0.025% Fluocinolone Acetonide Cream for Plaque Psoriasis: A Randomized Controlled Trial.
AU - Hamed Mamizadeh
AU - Hamideh Herizchi Ghadim
AU - Sajjad Pourasghary
PY - 2026
DA - 2026/10/21
JO - Psoriasis (Auckland, N.Z.)
DO - 10.2147/ptt.s647017
UR - https://europepmc.org/article/MED/42928804
AB - 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.
SN - 2230-326X
ER -