Topical 5% fluorouracil plus 0.005% calcipotriol for palmoplantar warts in children
Official title: Efficacy and Safety of 5-Fluorouracil (5FU) in Combination With Calcipotriol in Children (Aged 4 to 18 Years) With Palmoplantar Wart: Double-blind, Placebo-controlled, Randomized Trial
Run by Mazandaran University of Medical Sciences · NCT06737406 · Data updated 2026-11-12
This tests whether applying topical 5% fluorouracil plus 0.005% calcipotriol can clear palmoplantar warts in children 4 to 18 years old.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 18 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Mazandaran University of Medical Sciences Academic / other |
| Locations | 1 site (Sari, Mazandaran) |
| Status | Recruiting |
| Started | May 30, 2025 |
| Main results expected | July 1, 2026 |
| Study ends | August 1, 2026 |
| Registry record updated | December 19, 2025 |
| Trial ID | NCT06737406 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 4 to 18 with clinically diagnosed palmoplantar warts (maximum 20 lesions) who are not immunocompromised and have not received wart treatment in the prior two months are ideal candidates.
✕Probably not a fit
Children with facial, inguinal, or genital warts, extensive disease requiring other therapies, confirmed immunodeficiency, pregnancy or breastfeeding, or known hypersensitivity to fluorouracil or vitamin D derivatives are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children aged 4 to 18 with up to 20 palmoplantar warts will receive topical 5% fluorouracil cream combined with 0.005% calcipotriol ointment or matching placebo, applied to lesions under dermatology oversight. Treatment is given for a specified period with regular clinic visits to document wart size, number, clearance, and local side effects. Key exclusions include recent wart treatment, immunodeficiency, pregnancy or breastfeeding, and hypersensitivity to the study drugs. The main outcomes are wart clearance and treatment tolerability in the pediatric population.
Why it matters
Potential benefit: If effective, the combination could provide a simple, noninvasive topical option to clear painful or embarrassing palmoplantar warts in children.
How similar studies have gone: Similar topical combinations of 5-fluorouracil and calcipotriol have shown promise in small adult and pilot studies, but pediatric data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: The inclusion criteria include the clinical or pathological diagnosis (only for suspicious lesions confirmed pathologically) of cutaneous warts on the palmoplantar area by a dermatologist. The patients' ages range from 4 to 18 years old, and the number of warts must be a maximum of 20. Exclusion Criteria: The exclusion criteria include pregnancy and breastfeeding, warts on the face, inguinal, and genital areas, hypersensitivity to topical vitamin D derivatives or fluorouracil, extensive warts requiring other treatments, and receiving any treatment in the past two months. Patients with confirmed immunodeficiency will also be excluded from the study.
Where it's running
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Iran
Sari, Mazandaran, Iran Recruiting
Study contacts
- Study coordinator: Mohammad Malekan, MD
- Email: malekan.mohammad78@gmail.com
- Phone: +989117554873
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.