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The following is a summary of “DOES THE ADDITION OF HYALURONIDASE TO BETAMETHASONE IN TOPICAL TREATMENT OF PHIMOSIS IMPROVES RESULTS? – A RANDOMIZED DOUBLE-BLIND CLINICAL TRIAL,” published in the July 2024 issue of Pediatrics by Santos et al.

Phimosis, characterized by the inability to retract the foreskin, poses challenges in childhood urological care.

This study aimed to assess the comparative efficacy of betamethasone alone and in combination with hyaluronidase in topical treatment for phimosis, alongside evaluating systemic cortisol absorption and identifying predictive factors for treatment success in children aged 3 to 10 years.

In this randomized double-blinded clinical trial, 152 participants were enrolled, and divided into two groups: Group A received betamethasone valerate 2.5 mg combined with hyaluronidase 150 UTR, while Group B received betamethasone valerate 2.5 mg alone. Parents administered the ointment twice daily post-hygiene for 60 days and collected salivary cortisol samples at 11 pm and 9 am pre-and post-treatment. Evaluations occurred at 30 and 60 days, with Fisher’s exact test and paired t-tests used for statistical analysis.

Successful treatment outcomes were observed in 90 children (69.77%), with a success rate of 75.38% in Group A compared to 64.06% in Group B (p=0.18). Salivary cortisol analysis showed no significant systemic absorption differences between the groups (p>0.05), indicating the safety of both formulations regarding systemic cortisol levels. Age, adherence to treatment, presence of balanoposthitis, and prior corticosteroid use did not significantly influence treatment outcomes (p>0.05).

Topical therapy with betamethasone 0.2% combined with hyaluronidase for up to 60 days demonstrated comparable efficacy to betamethasone 0.2% alone in treating phimosis in children aged 3 to 10 years. The regimen proved safe and effective, yielding positive outcomes without significant systemic absorption of cortisol. Factors such as age, adherence, and clinical history did not predict treatment response, underscoring the need for continued exploration into individualized management approaches for pediatric phimosis.

Source: sciencedirect.com/science/article/abs/pii/S1477513124003450