Testing 5-Fluorouracil Cream Combined with Calcipotriol Ointment for Treating Palm and Sole Warts in Children Aged 4 to 18 Years

What this Trial Is About

Warts caused by the human papillomavirus HPV are a common skin condition in children, affecting 10 to 20 percent of school-aged kids. These warts can cause physical discomfort and psychological stress, especially plantar warts that cause pain while walking. Current treatments are varied but often painful and may not be effective, with a high recurrence rate. This research aims to evaluate the combination of two topical treatments, 5-fluorouracil and calcipotriol, in children aged 4 to 18 with palmoplantar warts to understand their efficacy and safety. The study is a randomized, double-blind, placebo-controlled clinical trial comparing three treatments 5% fluorouracil cream plus 0.005% calcipotriol ointment, 5% fluorouracil cream plus placebo, and 0.005% calcipotriol ointment plus placebo. Each treatment is applied twice daily for 21 days to the affected palmoplantar areas. Placebo creams and ointments are designed to look and smell identical to the active treatments to maintain blinding. Participants will be monitored for treatment response by recording the number and size of warts at 2, 4, and 8 weeks after starting treatment. Adverse events will also be assessed at these time points. Photographs will be taken at baseline and during follow-up visits to document changes. This study is sponsored by Mazandaran University of Medical Sciences and will run from May 2025 to August 2026.

Topical 5-Fluorouracil (5FU) Plus Calcipotriol in Children With Palmoplantar Wart