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

NCT ID: NCT06737406

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2026-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Common Warts

Keywords

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Wart 5-Fluorouracil Calcipotriol Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

5% fluorouracil cream + 0.005% calcipotriol ointment

Group Type EXPERIMENTAL

Topical 5% fluorouracil cream

Intervention Type DRUG

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

Topical 0.005% calcipotriol ointment

Intervention Type DRUG

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

B

5% fluorouracil cream + Placebo

Group Type EXPERIMENTAL

Topical 5% fluorouracil cream

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

C

0.005% calcipotriol ointment + Placebo

Group Type EXPERIMENTAL

Topical 0.005% calcipotriol ointment

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

A placebo cream in identical tubes in terms of color and scent and with identical usage instructions to fluorouracil.

Interventions

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Topical 5% fluorouracil cream

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

Intervention Type DRUG

Topical 0.005% calcipotriol ointment

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Placebo

A placebo cream in identical tubes in terms of color and scent and with identical usage instructions to fluorouracil.

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mazandaran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Malekan

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Iran

Sari, Mazandaran, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Mohammad Malekan, MD

Role: CONTACT

Phone: +989117554873

Email: [email protected]

Facility Contacts

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Mohammad Malekan, MD

Role: primary

Other Identifiers

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IR.MAZUMS.REC.1403.120

Identifier Type: -

Identifier Source: org_study_id