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

Not Applicable

Not yet recruiting

• Conditions: Common Warts
• Interventions: Drug: Topical 5% fluorouracil cream; Drug: Topical 0.005% calcipotriol ointment; Drug: Placebo

• Registration Number: NCT06737406
• Lead Sponsor: Mazandaran University of Medical Sciences

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 \[5, 6\].

In 2009, Gladsjo et al. conducted a randomized clinical trial to evaluate the therapeutic effect of 5% fluorouracil cream in children (4 to 18 years old) with skin warts. In this study, 40 children with skin warts, each having at least two warts on their hands, were enrolled. Patients were randomly assigned to one of two groups: once-daily application of the cream or twice-daily application. Patients and their parents were instructed to gently file each wart with an emery board before applying a small amount of 5% 5-FU cream with a cotton-tipped applicator. The primary outcome of the study was the complete clearance of study warts. Clinical evaluations were performed at baseline and after 1 week, 3 weeks, and 6 weeks of treatment. 88 percent of treated warts cleared after 6 weeks of treatment, and 41 percent of individuals cleared at least one wart. There was no difference in treatment response between once-daily and twice-daily application. No significant blood levels of 5-fluorouracil were detected in any subject. At the 6-month follow-up, 87 percent of complete responders had no wart recurrence. They concluded that 5% fluorouracil cream is a safe, effective, and well-tolerated treatment for warts in children \[1\].

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Study Start: 2025-02-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Topical 5% fluorouracil cream	5% fluorouracil cream + 0.005% calcipotriol ointment
A	Topical 0.005% calcipotriol ointment	5% fluorouracil cream + 0.005% calcipotriol ointment
B	Topical 5% fluorouracil cream	5% fluorouracil cream + Placebo
B	Placebo	5% fluorouracil cream + Placebo
C	Topical 0.005% calcipotriol ointment	0.005% calcipotriol ointment + Placebo
C	Placebo	0.005% calcipotriol ointment + Placebo

Primary Outcome Measures

Name	Time	Method
Treatment respone	The number of lesions is recorded at 2 weeks, 4 weeks, and 8 weeks after the intervention.	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.

Secondary Outcome Measures

Name	Time	Method
Number of Lesions	The number of lesions is recorded at 2 weeks, 4 weeks, and 8 weeks after the intervention.	This outcome measures the total count of wart lesions present on a patient at each assessment point during the study. The number of lesions is recorded before the start of treatment and monitored at regular intervals throughout the treatment period and follow-up visits. The change in the number of lesions over time helps assess the effectiveness of the treatment in reducing wart lesions.
Size Change (Number of Lesions)	The size change is evaluated at 2 weeks, 4 weeks, and 8 weeks after the intervention.	Size Change (Number of Lesions); This outcome tracks the change in size of the wart lesions over time, categorizing them into two options: * Decrease: The lesions have reduced in size compared to the initial measurement taken before the start of treatment.; * Increase: The lesions have grown in size compared to the initial measurement taken before the start of treatment.
Adverse Events	Adverse events are assessed at 2 weeks, 4 weeks, and 8 weeks after the intervention.	Adverse Events This outcome tracks the occurrence of any adverse events experienced by the patient during the study. Adverse events are monitored and recorded at each assessment point.; * No: The patient does not experience any adverse events related to the treatment.; * Yes: The patient experiences one or more adverse events. If "Yes," the adverse events are described in detail, including the type, severity, duration, and any measures taken to manage the events.
Photography	These photographs are taken at 0, 2 weeks, 4 weeks, and 8 weeks after the intervention.	Photographs are taken of all patients at each assessment point to document the visual appearance of the wart lesions. This provides a visual record to support the assessment of treatment response and size change.

Trial Locations

Locations (1)

Iran; 🇮🇷 Sari, Mazandaran, Iran, Islamic Republic of