Common WartsNCT06737406
Topical 5-Fluorouracil (5FU) Plus Calcipotriol in Children With Palmoplantar Wart
A study testing Topical 5% fluorouracil cream and Topical 0.005% calcipotriol ointment in people with Common Warts, run by Mazandaran University of Medical Sciences at 1 site in Iran.
Trial 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]. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Common Warts
- What is being tested?
- Topical 5% fluorouracil cream and Topical 0.005% calcipotriol ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- 30 May 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site, 1 recruiting
- Recruiting
Iran
Sari, Mazandaran
Mohammad Malekan, MD, +989117554873, malekan.mohammad78@gmail.com
About this study
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
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].
Read more
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
- Being tested
- Topical 5% fluorouracil cream, Topical 0.005% calcipotriol ointment, Placebo
- Keywords
- Wart, 5-Fluorouracil, Calcipotriol, Children
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical 5% fluorouracil creamDrug
Topical 5% fluorouracil cream twice daily for 21 days on the affected area (palmoplantar)
Topical 0.005% calcipotriol ointmentDrug
Topical 0.005% calcipotriol ointment twice daily for 21 days on the affected area (palmoplatar)
PlaceboDrug
A placebo ointment in identical tubes in terms of color and scent and with identical usage instructions to calcipotriol.
PlaceboDrug
A placebo cream in identical tubes in terms of color and scent and with identical usage instructions to fluorouracil.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 5% fluorouracil cream + 0.005% calcipotriol ointment Receives: Drug: Topical 5% fluorouracil cream; Drug: Topical 0.005% calcipotriol ointment |
| B | Experimental | 5% fluorouracil cream + Placebo Receives: Drug: Topical 5% fluorouracil cream; Drug: Placebo |
| C | Experimental | 0.005% calcipotriol ointment + Placebo Receives: Drug: Topical 0.005% calcipotriol ointment; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The number of lesions is recorded at 2 weeks, 4 weeks, and 8 weeks after the intervention.
Secondary outcomes (4)
Number of Lesions
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.
Measured: The number of lesions is recorded at 2 weeks, 4 weeks, and 8 weeks after the intervention.
Size Change (Number of Lesions)
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.
Measured: The size change is evaluated at 2 weeks, 4 weeks, and 8 weeks after the intervention.
Adverse Events
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.
Measured: Adverse events are assessed at 2 weeks, 4 weeks, and 8 weeks after the intervention.
Photography
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.
Measured: These photographs are taken at 0, 2 weeks, 4 weeks, and 8 weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start30 May 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mazandaran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Malekan, Mazandaran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737406
- Sponsor's protocol ID
- IR.MAZUMS.REC.1403.120
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06737406
- Acronym / sponsor ID
- IR.MAZUMS.REC.1403.120
- Conditions
- Common Warts
- Keywords
- Wart, 5-Fluorouracil, Calcipotriol, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mazandaran University of Medical SciencesUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Topical 5% fluorouracil cream, Drug: Topical 0.005% calcipotriol ointment5% fluorouracil cream + 0.005% calcipotriol ointment |
| B | Experimental | Drug: Topical 5% fluorouracil cream, Drug: Placebo5% fluorouracil cream + Placebo |
| C | Experimental | Drug: Topical 0.005% calcipotriol ointment, Drug: Placebo0.005% calcipotriol ointment + Placebo |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical 5% fluorouracil creamTopical 5% fluorouracil cream twice daily for 21 days on the affected area (palmoplantar) | Drug | A, B |
| Topical 0.005% calcipotriol ointmentTopical 0.005% calcipotriol ointment twice daily for 21 days on the affected area (palmoplatar) | Drug | A, C |
| PlaceboA placebo ointment in identical tubes in terms of color and scent and with identical usage instructions to calcipotriol. | Drug | B |
| PlaceboA placebo cream in identical tubes in terms of color and scent and with identical usage instructions to fluorouracil. | Drug | C |
Primary outcome
Treatment respone
Time frame: 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.
4 secondary outcomes
Number of Lesions
Time frame: The number of lesions is recorded at 2 weeks, 4 weeks, and 8 weeks after the intervention.
Size Change (Number of Lesions)
Time frame: The size change is evaluated at 2 weeks, 4 weeks, and 8 weeks after the intervention.
Adverse Events
Time frame: Adverse events are assessed at 2 weeks, 4 weeks, and 8 weeks after the intervention.
Photography
Time frame: These photographs are taken at 0, 2 weeks, 4 weeks, and 8 weeks after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical 5% fluorouracil cream and Topical 0.005% calcipotriol ointment in people with Common Warts, run by Mazandaran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Malekan, MD (+989117554873, malekan.mohammad78@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment respone (time frame: The number of lesions is recorded at 2 weeks, 4 weeks, and 8 weeks after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.