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

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.