Plantar Warts TreatmentPhase 4NCT07196670
Intralesional Vitamin D Versus Intralesional Acyclovir in Plantar Warts
A Phase 4 study testing intralesional vitamin D3 versus intralesional acyclovir in people with Plantar Warts Treatment, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Warts Treatment
- What is being tested?
- intralesional vitamin D3 versus intralesional acyclovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Jan 2026
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with plantar warts, both sex, above 18 years old
Who cannot join
- 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
About this study
Official title: Intralesional Vitamin D Versus Intralesional Acyclovir in Plantar Warts: a Single-blinded Randomized Clinical Trial With Clinico-dermoscopic Evaluation
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.
Read more
- 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:
- Proper history taking and physical examination. Number and size of warts shall be noted.
- Informed consent
- Dermoscopic evaluation of the lesions by Fotofinder Medicam 800HD dermoscope
- 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)
- Conditions
- Plantar Warts Treatment
- Being tested
- intralesional vitamin D3 versus intralesional acyclovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intralesional vitamin D3 versus intralesional acyclovirDrug
injecting intralesional vitamin D in group A versus injecting intralesional acyclovir in group B in treatment of plantar warts
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Group A will receive intralesional vitamin D3 into the base of the largest wart Receives: Drug: intralesional vitamin D3 versus intralesional acyclovir |
| group B | Active comparator | Group B will receive intralesional acyclovir into the base of the largest wart Receives: Drug: intralesional vitamin D3 versus intralesional acyclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the percentage of decrease in size and number of plantar warts after intralesional vitamin D versus intralesional acyclovir
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar Warts TreatmentStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Aly Abdel Aziz Gaballah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196670
- Sponsor's protocol ID
- CairoUniversityKasralainy
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2025
- Last updated
- 29 Sep 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 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Vitamin D Versus Intralesional Acyclovir in Plantar Warts: a Single-blinded Randomized Clinical Trial With Clinico-dermoscopic Evaluation
- ClinicalTrials.gov ID
- NCT07196670
- Acronym / sponsor ID
- CairoUniversityKasralainy
- Conditions
- Plantar Warts Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 29 Sep 2025 (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.
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:
- Proper history taking and physical examination. Number and size of warts shall be noted.
- Informed consent
- Dermoscopic evaluation of the lesions by Fotofinder Medicam 800HD dermoscope
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: intralesional vitamin D3 versus intralesional acyclovirGroup A will receive intralesional vitamin D3 into the base of the largest wart |
| group B | Active comparator | Drug: intralesional vitamin D3 versus intralesional acyclovirGroup B will receive intralesional acyclovir into the base of the largest wart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with plantar warts, both sex, above 18 years old
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| intralesional vitamin D3 versus intralesional acyclovirinjecting intralesional vitamin D in group A versus injecting intralesional acyclovir in group B in treatment of plantar warts | Drug | group A, group B |
Primary outcome
comparing the percentage of decrease in size and number of plantar warts after intralesional vitamin D versus intralesional acyclovir
Time frame: 3 months
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 29 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intralesional vitamin D3 versus intralesional acyclovir in people with Plantar Warts Treatment, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing the percentage of decrease in size and number of plantar warts after intralesional vitamin D versus intralesional acyclovir (time frame: 3 months). 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 29 Sep 2025.