ClinicalTrials.gg
RecruitingNCT07937007Updated Nov 13, 2026

Vitamin D3 Versus Methotrexate Versus Saline Injections for Plantar Warts

An interventional study of Cholecalciferol (Vit D3) and Methotrexate in Plantar Warts, sponsored by Kafrelsheikh University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Aug 2025, registered Nov 2026).
  • Started Aug 2025; still recruiting 1 year 3 months later.
Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 30 studies in Warts with a site in Egypt — 5 open to participants now, 5 under way, 1 of them phase 3. Warts · Egypt.

Planned enrollment
14th of 26
60 · median 62
Started
2025
with 1 other
No phase
10 of 30
3 open now
Registered
30th of 30
by date
Lead sponsor
1 of 30
Kafrelsheikh University

Among the 30 studies in Warts with a site in Egypt, this one is the 14th largest by planned enrollment of the 26 interventional ones that give a count, is one of 2 that started in 2025, is one of 10 with no phase, and was the 30th registered.

Warts

172 studies on the registry are indexed under Warts; 36 are open to participants now.

Browse Warts studies →

Open to participants now

5 of the 30 studies in Warts with a site in Egypt are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 19 Warts studies recruiting now, 10 (53%) set no upper age limit and 9 (47%) stop at 75 or younger; 12 take children under 18; 1 takes healthy volunteers.

This study: 18 Years to 50 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in Warts with a site in Egypt, or all of them as a file.
02

Study summary

This clinical trial will compare vitamin D3 injections, methotrexate injections, and saline injections for plantar warts. Plantar warts are warts on the soles of the feet. The study will include 60 adults aged 18 to 50 years at Kafrelsheikh University Hospital, Egypt.

The main questions are:

  • How well does each treatment clear plantar warts?
  • What side effects occur with each treatment?
  • Do the warts return after treatment?

Participants will be assigned by chance to one of three groups, with 20 participants in each group:

  • Vitamin D3 injections into the warts.
  • Methotrexate injections into the warts.
  • Saline injections into the warts. Saline is a saltwater solution used as a placebo comparison.

Participants will receive injections once a week until their

Read the detailed description

This randomized, controlled, three-arm, parallel-group clinical trial will evaluate the efficacy and safety of intralesional vitamin D3 and intralesional methotrexate compared with intralesional saline placebo for plantar warts. The protocol describes the study as double-blind.

Participants will be recruited from the outpatient clinics of the Department of Dermatology and Venereology, Kafrelsheikh University Hospital, Egypt. Plantar warts will be diagnosed clinically, with dermoscopic examination used when the diagnosis is uncertain. Sixty eligible participants will be randomly assigned to three groups of 20 participants each.

Baseline evaluation will include medical history, wart duration, previous treatments, recurrence history, general examination, and assessment of wart size and number. Laboratory investigations will include a complete blood count, liver and kidney function tests, and serum calcium measurement before treatment and one week after the final treatment session.

Treatment sessions will take place weekly until complete clearance or a maximum of six sessions. Before injection, a topical lidocaine/prilocaine anesthetic cream will be applied under occlusion for one hour. The treatment area will then be cleaned with 70% alcohol. Assigned treatment will be injected into the base of the wart using a 27-gauge insulin syr

03

Conditions studied

  • Plantar Warts

Browse trials for

Keywords

  • Verruca Plantaris
  • Vitamin D3
  • Cholecalciferol
  • Methotrexate
  • Intralesional Injection
  • Dermoscopy
  • Wart Recurrence
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 to 50 years.
  • Clinical diagnosis of plantar warts, with dermoscopic confirmation when the diagnosis is uncertain.
  • Willingness to participate and provide written .

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Use of systemic or topical treatments for warts within the month before enrollment.
  • diseases or current use of immunosuppressive drugs.
  • Hypercalcemia.
  • Renal disease or renal impairment.
  • Known to any ingredient of the products.
  • History of chronic disease, including hepatic disease or bleeding diathesis.
  • Local inflammation or infection.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Intralesional Vitamin D3

    Twenty participants will receive intralesional cholecalciferol (vitamin D3) injections into the base of plantar warts. A volume of 0.2-0.4 mL will be injected per lesion, treating a maximum of five warts per session. Sessions will take place weekly until complete clearance or a maximum of six sessions.

    Drug: Cholecalciferol (Vit D3)

  • Experimental
    Intralesional Methotrexate

    Twenty participants will receive intralesional methotrexate at a concentration of 25 mg/mL, injected into the base of each plantar wart until blanching occurs. A maximum of five warts will be treated per session. Sessions will take place weekly until complete clearance or a maximum of six sessions.

    Drug: Methotrexate

  • Placebo comparator
    Intralesional Saline Placebo

    Twenty participants will receive intralesional saline injections into the base of plantar warts. Sessions will take place weekly until complete clearance or a maximum of six sessions.

    Drug: Saline Placebo

Interventions

  • Cholecalciferol will be administered by intralesional injection into the base of each treated plantar wart using a 27-gauge insulin syringe. The injection volume will be 0.2-0.4 mL per lesion, with a maximum of five warts treated per session. Treatment will be administered weekly until complete clearance or a maximum of six sessions.

  • Methotrexate injection, supplied as 50 mg/2 mL and used at a concentration of 25 mg/mL, will be administered into the base of each treated plantar wart using a 27-gauge insulin syringe until blanching occurs. A maximum of five warts will be treated per session. Treatment will be administered weekly until complete clearance or a maximum of six sessions.

  • DrugSaline Placebo

    Saline will be administered as a placebo by intralesional injection into the base of plantar warts using a 27-gauge insulin syringe. Treatment will be administered weekly until complete clearance or a maximum of six sessions.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving Complete Clearance of Plantar Warts

    Complete response is defined as disappearance of plantar warts with restoration of normal-appearing skin, assessed by clinical and dermoscopic examination. The percentage of participants achieving complete response will be compared among treatment groups.

    Time frame: One month after the final treatment session

Secondary outcomes

  1. Clinical and Dermoscopic Treatment Response Category

    Treatment response will be classified as complete response (appearance of normal skin), partial response (at least 50% but less than 100% reduction in original wart diameter and/or number), poor response (less than 50% reduction), or no response (no improvement). The distribution of participants across response categories will be compared among treatment groups.

    Time frame: One month after the final treatment session

  2. Change From Baseline in Number of Plantar Warts

    The number of plantar warts will be recorded by clinical examination. Change will be calculated relative to the baseline wart count. A decrease in wart number indicates improvement.

    Time frame: Baseline, weekly during treatment for up to six sessions, and one month after the final treatment session

  3. Change From Baseline in Plantar Wart Diameter

    Wart diameter will be measured using a ruler and compared with baseline measurements. A decrease in diameter indicates improvement.

    Time frame: Baseline, weekly during treatment for up to six sessions, and one month after the final treatment session

  4. Change in Dermoscopic Features of Plantar Warts

    Serial dermoscopic examinations and photographs will assess changes in black dots, red dots, and skin-line patterns within plantar wart lesions relative to baseline.

    Time frame: Baseline, weekly during treatment for up to six sessions, and one month after the final treatment session

  5. Patient Satisfaction With Treatment Outcome

    Participants will categorize their satisfaction with the treatment outcome as not satisfied, slightly satisfied, or highly satisfied. The distribution of responses will be compared among treatment groups.

    Time frame: One month after the final treatment session

  6. Percentage of Participants With Recurrence of Plantar Warts After Complete Clearance

    Among participants who achieve complete clearance, the percentage with reappearance of plantar warts during post-treatment follow-up will be reported.

    Time frame: Through 3 months after the final treatment session

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Nov 2026, 15 months after the start.

Of 29 interventional studies with no phase under Warts, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 15 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2026
First posted
Nov 13, 2026
StartActual
Aug 1, 2025
Primary completionEst.
Nov 2026
CompletionEst.
Dec 2026
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07937007
Responsible party
Noura Abdelmoneim Mohammed Elseessy (Assistant Professor, Kafrelsheikh University) — Principal investigator
First posted
Nov 13, 2026
Start date
Aug 1, 2025
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 13, 2026

Study contacts

Noura El seessy, MD, PhD
Contact
Nora_Elsiesy@med.kfs.edu.eg
+201000117186

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Cholecalciferol · Methotrexate

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