Randomized trial evaluates clioquinol cream for balanoposthitis symptoms, indicating clinical improvement but no significant difference from placebo.
Background Balanoposthitis is a common condition involving the male reproductive system. Currently, the pathogenesis of balanoposthitis remains unclear. Objectives The aim of this article is to investigate the clinical, male genital mucosal barrier function and microbial characteristics of BP and to evaluate the effects of clioquinol cream. Materials and Methods Patients were randomized with a planned allocation ratio of 1:1 to receive clioquinol cream or placebo (vehicle cream) twice daily for a 4‐week study, with 2 weeks of treatment followed by 2 weeks of discontinuation. The transepidermal water loss (TEWL), skin hydration (SH), and pH value were measured. Clinical assessments of their symptoms, signs, and calculation of the disease severity score were conducted. Mean score improvement rates were also calculated at Weeks 1, 2, and 4. In addition, genital microbial characteristics were analyzed using 16S rRNA sequencing. Results A total of 37 patients were enrolled and randomized, including 20 in the placebo group and 17 in the clioquinol cream group. After a two‐week treatment, both groups improved during treatment. Disease severity scores decreased significantly over time ( p < 0.001). However, there was no significant main effect of group ( p > 0.05) or significant group‐by‐time interaction ( p > 0.05). The mean score improvement rates in the placebo group were 44.8%, 83.7%, and 81.1% at Weeks 1, 2, and 4, respectively, compared with 66.7%, 85.1%, and 86.5% in the clioquinol cream group. In addition, some bacteria and fungi showed a decline to varying degrees. Bacteria including Prevotella bivia , Streptococcus agalactiae , Haemophilus parainfluenzae , Anaerococcus vaginalis , Bacteroides , and coagulans and fungi such as Candida albicans and Fusarium solani were identified as potentially involved in the pathogenic process of balanoposthitis. Conclusion In this study, both groups demonstrated clinical improvement during the treatment, with no statistically significant difference observed between clioquinol cream and placebo. Many bacteria and fungi, such as Prevotella bivia and Candida albicans , potentially play a role in the pathogenesis of balanoposthitis. Trial Registration: Chinese Clinical Trial Registry: ChiCTR2000034813
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Wang et al. (2026) studied this question.
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