Topical Fluticasone Propionate Versus Fusidic Acid for Zoon’s Balanitis in Men: A Prospective, Open-Label, Non-Randomised Comparative Study with an Exploratory Long-Term Assessment
- 1Department of Dermatology, Venerology and Allergology, Medical University of Gdańsk, Mariana Smoluchowskiego 17, 80-214 Gdańsk, Poland
- 2Department of Urology, Medical University of Gdańsk, Mariana Smoluchowskiego 17, 80-214 Gdańsk, Poland
Abstract
Background: Prospective comparative evidence for topical treatment of Zoon’s balanitis is limited. We evaluated early clinical changes during two topical regimens and explored recorded long-term outcomes. Methods: In this single-centre, prospective, open-label, non-randomised study, 37 men with histopathologically confirmed Zoon’s balanitis were allocated by alternation to fluticasone propionate 0.05% (n = 18) or fusidic acid 2% (n = 19) for four weeks. Early assessments used a four-point study Investigator’s Global Assessment (IGA) and symptom visual analogue scales. Additional exploratory comparisons included IGA 0 at week 4. A separate categorical assessment was undertaken in 2026. The study was not registered in a public clinical-trial registry. Results: Mean IGA decreased from 2.17 to 0.67 with fluticasone and from 2.26 to 0.89 with fusidic acid between baseline and week 4. Complete clearance occurred in 8/18 (44.4%) and 6/19 (31.6%) participants, respectively; the absolute difference was 12.9 percentage points (95% confidence interval, −17.1 to 40.1; Fisher’s exact p = 0.50768). Among participants assessable in 2026, recorded remission occurred in 12/16 (75.0%) and 3/15 (20.0%), respectively (unadjusted odds ratio, 12.00; approximate 95% confidence interval, 2.20–65.52; p = 0.00385). These data did not establish uninterrupted or treatment-free remission; missing-outcome sensitivity analyses limited the robustness of the association. Conclusions: Clinical severity improved during both regimens, but comparative equivalence was not established. The association between initial fluticasone allocation and recorded remission in 2026 is hypothesis-generating and requires confirmation in a registered, adequately powered controlled study with standardised long-term assessment.
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BibTeX
@article{czajkowska2026topical,
title = {{Topical Fluticasone Propionate Versus Fusidic Acid for Zoon’s Balanitis in Men: A Prospective, Open-Label, Non-Randomised Comparative Study with an Exploratory Long-Term Assessment}},
author = {Katarzyna Czajkowska and Mateusz Czajkowski and Roman Janusz Nowicki and Marcin Matuszewski and Małgorzata Sokołowska-Wojdyło},
journal = {Journal of Clinical Medicine},
year = {2026},
month = nov,
doi = {10.3390/jcm15218515},
url = {https://www.mdpi.com/2077-0383/15/21/8515},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Topical Fluticasone Propionate Versus Fusidic Acid for Zoon’s Balanitis in Men: A Prospective, Open-Label, Non-Randomised Comparative Study with an Exploratory Long-Term Assessment
AU - Katarzyna Czajkowska
AU - Mateusz Czajkowski
AU - Roman Janusz Nowicki
AU - Marcin Matuszewski
AU - Małgorzata Sokołowska-Wojdyło
PY - 2026
DA - 2026/11/02
JO - Journal of Clinical Medicine
DO - 10.3390/jcm15218515
UR - https://www.mdpi.com/2077-0383/15/21/8515
AB - Background: Prospective comparative evidence for topical treatment of Zoon’s balanitis is limited. We evaluated early clinical changes during two topical regimens and explored recorded long-term outcomes. Methods: In this single-centre, prospective, open-label, non-randomised study, 37 men with histopathologically confirmed Zoon’s balanitis were allocated by alternation to fluticasone propionate 0.05% (n = 18) or fusidic acid 2% (n = 19) for four weeks. Early assessments used a four-point study Investigator’s Global Assessment (IGA) and symptom visual analogue scales. Additional exploratory comparisons included IGA 0 at week 4. A separate categorical assessment was undertaken in 2026. The study was not registered in a public clinical-trial registry. Results: Mean IGA decreased from 2.17 to 0.67 with fluticasone and from 2.26 to 0.89 with fusidic acid between baseline and week 4. Complete clearance occurred in 8/18 (44.4%) and 6/19 (31.6%) participants, respectively; the absolute difference was 12.9 percentage points (95% confidence interval, −17.1 to 40.1; Fisher’s exact p = 0.50768). Among participants assessable in 2026, recorded remission occurred in 12/16 (75.0%) and 3/15 (20.0%), respectively (unadjusted odds ratio, 12.00; approximate 95% confidence interval, 2.20–65.52; p = 0.00385). These data did not establish uninterrupted or treatment-free remission; missing-outcome sensitivity analyses limited the robustness of the association. Conclusions: Clinical severity improved during both regimens, but comparative equivalence was not established. The association between initial fluticasone allocation and recorded remission in 2026 is hypothesis-generating and requires confirmation in a registered, adequately powered controlled study with standardised long-term assessment.
SN - 2077-0383
ER -