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Not yet recruitingNCT07196670Updated Sep 29, 2025

Intralesional Vitamin D Versus Intralesional Acyclovir in Plantar Warts

A Phase 4 interventional study of intralesional vitamin D3 versus intralesional acyclovir in Plantar Warts Treatment, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Cairo University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to compare intralesional vitamin D versus intralesional acyclovir in the treatment of plantar warts. It will also learn about the safety of both techniques. The main questions it aims to answer are:

which is more effective in the treatment of plantar warts? What medical problems do participants have when taking both? What is the recurrence rate in both treatment modalities? Participants will:• Sixty plantar warts patients will be included in this study.

  • They will be randomly allocated into two groups: intralesional vitamin D group (group A) and intralesional Acyclovir group (group B). Patients will be blinded to their therapeutic arm.
  • All patients will be subjected to the following:

    1. Proper history taking and physical examination. Number and size of warts shall be noted.
    2. Informed consent
    3. Dermoscopic evaluation of the lesions by Fotofinder Medicam 800HD dermoscope
    4. Digital photography of the lesions
  • Group A:

The aqueous solution of vitamin D3 is used (Devarol S 200,000IU/2ml ) 0.6 ml (60,000 IU ) will be slowly injected into the base of the largest wart Injections will be repeated at 3 week intervals till resolution of warts or for a maximum of 4 sessions Any hyperkeratotic lesions will be pared before injection

  • Group B: Acyclovir vial (250 mg) will be diluted with 3.5 ml saline to get approximately 70 mg/ml solution 0.1 ml will be slowly injected into the base of the largest wart Injections will be repeated at 3 week intervals till resolution of warts or for a maximum of 4 sessions Any hyperkeratotic lesion will be pared before injection
  • Follow up:

After cessation of treatment, there will be one month follow up during which:

  • Patient will be questioned about side effects
  • Physical examination to check response and/or detect recurrence
  • Photography in the same positions
  • Size of the warts shall be noted
  • Number of warts shall be noted

    • Dermoscopic evaluation:

Patients will be examined with Fotofinder Medicam 800HD dermoscope Assessment of size and percentage of red dots and linear vessels per field At baseline, then after completion of treatment sessions and finally after 1 month from the last treatment session.

  • Based on clinical, photographic and dermoscopic data, response will be graded by a blinded observer as follows: Complete response (100% disappearance of warts) Partial response (50-\<100% decrease in wart size) No response (\<50% decrease in wart size)
02

Conditions studied

  • Plantar Warts Treatment
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with plantar warts, both sex, above 18 years old

Exclusion criteria

Exclusion Criteria:

  • under 18 years old, hypersensitivity to vitamin D or intralesional acyclovir, patients on systemic acyclovir and vitamin D, pregnant or lactating females, cognitively impaired patients
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    group A

    Group A will receive intralesional vitamin D3 into the base of the largest wart

    Drug: intralesional vitamin D3 versus intralesional acyclovir

  • Active comparator
    group B

    Group B will receive intralesional acyclovir into the base of the largest wart

    Drug: intralesional vitamin D3 versus intralesional acyclovir

Interventions

  • Drugintralesional vitamin D3 versus intralesional acyclovir

    injecting intralesional vitamin D in group A versus injecting intralesional acyclovir in group B in treatment of plantar warts

06

What researchers measure

Primary outcomes

  1. comparing the percentage of decrease in size and number of plantar warts after intralesional vitamin D versus intralesional acyclovir

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07196670
Lead sponsor
Cairo University
Responsible party
Basma Aly Abdel Aziz Gaballah (lecturer of dermatology, Cairo University) — Principal investigator
First posted
Sep 29, 2025
Start date
Sep 2025 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Jan 2026 (estimated)
Last update
Sep 29, 2025

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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