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

NCT06737406 | Recruiting

• 1 other identifier: IR.MAZUMS.REC.1403.120
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Warts caused by the human papillomavirus (HPV) are one of the most common skin conditions among children. The prevalence of warts in school-aged children ranges from 10 to 20 percent. Warts are more common among immunocompromised patients \[1, 2\]. Some studies also show that the prevalence of viral warts in the pediatric population increases with age, peaking in adolescence. HPV is a DNA virus that replicates only in fully differentiated epithelial cells. More than 80 types of HPV have been identified. Types 27, 57, 2, and 1 are the most common types of HPV in skin warts in the general population. Warts usually affect patients of different age groups and various parts of the body, causing physical and psychological complications for patients (such as pain, discomfort, and embarrassment), which in turn lead to functional impairment. Warts often affect pressure points on the soles of the feet. Although most warts are asymptomatic, plantar warts are often associated with pain while walking, causing physical and psychological stress \[3\]. Various treatments such as keratolytic agents, cryotherapy, laser, antimitotic treatments, contact sensitizers, and intralesional injection of antigen have been used. There is no evidence that one treatment is superior to others, and in many cases, treatment of viral warts requires a combination of treatments. Treatment selection for patients should be based on variables such as wart size, number of lesions, anatomical location, patient preference, cost, convenience, side effects, and operator experience. It is important to emphasize that good communication between the patient, parents, and dermatologist is essential for successful treatment in children \[2, 4\]. Despite having various treatment approaches, treating plantar warts is challenging. No single treatment is effective in most patients, treatments are often painful, and they are associated with a high recurrence rate. Although nearly 75 percent of warts can resolve spontaneously within two years, patients often seek treatment for cosmetic reasons and pain. Many studies have examined the use of vitamin D compounds (calcipotriol) and 5-fluorouracil in wart patients separately or in combination with other drugs, but only one recent case report that tested the combination of these two showed very positive efficacy results \[5, 6\]. To date, no clinical trial has evaluated the combination of calcipotriol and 5-fluorouracil. Additionally, given that common current treatments such as cryotherapy are painful for children, achieving an effective, pain-free intervention is necessary. This study aims to evaluate the efficacy and side effects of the combination of 5-fluorouracil and calcipotriol in children (ages 4 to 18) with palmar and plantar warts in a randomized, double-blind, placebo-controlled clinical trial.

Conditions

Common Warts

Keywords

Wart; 5-Fluorouracil; Calcipotriol; Children

Outcome Measures

Primary Outcomes (1)

• Treatment respone

  Treatment respone * No response: The wart shows no visible reduction in size, texture, or color, and there is no improvement in symptoms after the treatment. * Partial or Poor response: The wart demonstrates a reduction in size, texture, or color, but it is not completely resolved. Some improvement in symptoms may be noted, but the wart remains partially present. * Complete response: The wart is fully resolved with no visible signs remaining. All symptoms are eliminated, and the skin appears almost normal at the site of the wart.

  The number of lesions is recorded at 2 weeks, 4 weeks, and 8 weeks after the intervention.

Secondary Outcomes (4)

• Number of Lesions

  The number of lesions is recorded at 2 weeks, 4 weeks, and 8 weeks after the intervention.

• Size Change (Number of Lesions)

  The size change is evaluated at 2 weeks, 4 weeks, and 8 weeks after the intervention.

• Adverse Events

  Adverse events are assessed at 2 weeks, 4 weeks, and 8 weeks after the intervention.

• Photography

  These photographs are taken at 0, 2 weeks, 4 weeks, and 8 weeks after the intervention.

Study Arms (3)

A

EXPERIMENTAL

5% fluorouracil cream + 0.005% calcipotriol ointment

Drug: Topical 5% fluorouracil cream; Drug: Topical 0.005% calcipotriol ointment

B

EXPERIMENTAL

5% fluorouracil cream + Placebo

Drug: Topical 5% fluorouracil cream; Drug: Placebo

C

EXPERIMENTAL

0.005% calcipotriol ointment + Placebo

Drug: Topical 0.005% calcipotriol ointment; Drug: Placebo

Interventions

Topical 5% fluorouracil cream DRUG

Topical 5% fluorouracil cream twice daily for 21 days on the affected area (palmoplantar)

A; B

Topical 0.005% calcipotriol ointment DRUG

Topical 0.005% calcipotriol ointment twice daily for 21 days on the affected area (palmoplatar)

A; C

Placebo DRUG

A placebo ointment in identical tubes in terms of color and scent and with identical usage instructions to calcipotriol.

B

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Mazandaran University of Medical Sciences: lead

Study Sites (1)

Iran

Sari, Mazandaran, Iran

RECRUITING

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Mohammad Malekan, MD

CONTACT

+989117554873; malekan.mohammad78@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: This study will be a single-center, parallel, randomized, double-blind, placebo-controlled trial. Patients who meet eligibility criteria will be randomized (1:1:1) to one of 3 groups. Group A will receive 5% fluorouracil cream and 0.005% calcipotriol ointment. Group B will receive 5% fluorouracil cream and a placebo ointment in identical tubes in terms of color and scent and with identical usage instructions to calcipotriol. Group C will receive 0.005% calcipotriol ointment and a placebo cream in identical tubes with identical instructions to fluorouracil. All patients applied a thin layer of ointment and cream to the affected area (palmoplantar) twice daily for 3 consecutive weeks (21 days).

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: May 30, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

IR (1)