Topical 5% fluorouracil plus 0.005% calcipotriol for palmoplantar warts in children
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
This tests whether applying topical 5% fluorouracil plus 0.005% calcipotriol can clear palmoplantar warts in children 4 to 18 years old.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | Mazandaran University of Medical Sciences Academic / other |
| Locations | 1 site (Sari, Mazandaran) |
| Trial ID | NCT06737406 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Similar topical combinations of 5-fluorouracil and calcipotriol have shown promise in small adult and pilot studies, but pediatric data remain limited.
Eligibility criteria
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 this trial is running
Sari, Mazandaran
- Iran — Sari, Mazandaran, Iran (Recruiting)
Study contacts
- Study coordinator: Mohammad Malekan, MD
- Email: malekan.mohammad78@gmail.com
- Phone: +989117554873
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.