Viral WartPhase 4NCT07448844
Intralesional Therapies For Cutaneous Viral Warts: A Comparative Analysis Of Vitamin D3 And Acyclovir
A Phase 4 study testing Intralesional Acyclovir and Intralesional Vitamin D3 in people with Viral Wart and Plantar Wart, run by Riphah International University at 2 sites in Pakistan.
Trial summary
The goal of this clinical trial is to learn if injecting acyclovir (an antiviral drug) or vitamin D3 directly into skin warts works to clear them in people aged 12 and older with common, plantar, flat, or periungual (around the nail) warts. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Viral Wart, Plantar Wart, Common Warts (Verruca Vulgaris)
- What is being tested?
- Intralesional Acyclovir and Intralesional Vitamin D3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesPakistan
- Study dates
- 20 Feb 2026to 20 Sep 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 12 years and above with clinically diagnosed cutaneous warts
- Common, plantar, flat, or periungual warts
- Both treatment-naïve patients and those with recalcitrant warts
Who cannot join
- Pregnant or lactating women
- Immunocompromised patients
- Individuals with history of hypersensitivity to vitamin D3 or acyclovir
- Individuals receiving systemic immunosuppressive or antiviral therapy
- Patients with secondary infection at injection site
- Patients who had received any topical or destructive treatment for wart in previous three months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Riphah International Hospital, Islamabad Expy, Sector A DHA Phase 5, Islamabad
Islamabad, 44000
Fatima Sajid, FCPS, +92 334 435 2228, fatima.sajid@riphah.edu.pk
Fatima Sajid, FCPS
- Recruiting
Railway General Hospital, Railway Carriage Factory Rd, Railway Scheme 7, Rawalpindi
Rawalpindi, Punjab Province, 46000
Nadia Ghazanfar, FCPS, +92 312 5328994, nadia.ghazanfar@riphah.edu.pk
Nadia Ghazanfar, FCPS
About this study
The goal of this clinical trial is to learn if injecting acyclovir (an antiviral drug) or vitamin D3 directly into skin warts works to clear them in people aged 12 and older with common, plantar, flat, or periungual (around the nail) warts. The main questions it aims to answer are:
- Does intralesional acyclovir or vitamin D3 lead to complete clearance of warts by week 8?
- Which treatment clears warts more effectively?
- What side effects do participants have with each treatment?
Read more
Researchers will compare acyclovir injections (Group A) to vitamin D3 injections (Group B), with 20 participants in each group, to see which treatment works better at clearing warts.
Participants will:
- Receive an injection directly into the wart every 2 weeks for up to 4 sessions
- Have photographs taken of their warts before treatment and at each visit
- Visit the clinic for checkups where the size and number of warts will be measured
- Be followed for up to 3 months to check for wart recurrence and side effects
- Conditions
- Viral Wart, Plantar Wart, Common Warts (Verruca Vulgaris), Common Wart, Flat Wart, Warts of Foot
- Being tested
- Intralesional Acyclovir, Intralesional Vitamin D3
- Keywords
- Cutaneous warts, intralesional therapy, treatment efficacy, plantar warts, common warts, human papillomavirus, randomized controlled trial, vitamin D3, acyclovir, flat warts
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional AcyclovirDrug
Acyclovir (70 mg/mL) prepared by reconstituting a 250 mg vial with 3.5 mL of distilled water, injected directly into the wart lesion. Dosing is based on lesion size: 0.2 mL for warts ≤0.5 cm, 0.3-0.5 mL for 0.5-1 cm, and 0.5-1 mL for 1-1.5 cm. Administered at baseline and every 2 weeks for up to four sessions.
Intralesional Vitamin D3Drug
Vitamin D3 (200,000 IU; 5 mg/mL) injected directly into the wart lesion. Dosing is based on lesion size: 0.2 mL for warts ≤0.5 cm, 0.3-0.5 mL for 0.5-1 cm, and 0.5-1 mL for 1-1.5 cm. Administered at baseline and every 2 weeks for up to four sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intralesional Acyclovir | Experimental | Participants receive intralesional injection of acyclovir. Injections are administered at baseline and repeated every 2 weeks for a maximum of four sessions. Receives: Drug: Intralesional Acyclovir |
| Intralesional Vitamin D3 | Active comparator | Participants receive intralesional injection of vitamin D3 (200,000 IU). Injections are administered at baseline and repeated every 2 weeks for a maximum of four sessions. Receives: Drug: Intralesional Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response at Week 8
Clinical response categorized as complete clearance (100% resolution of wart), partial response (reduction in size or number of warts but not complete clearance), or no response (no change or increase in size or number of warts). Assessed by an independent blinded investigator using clinical examination and standardized digital photographs.
Measured: 8 weeks from baseline
Secondary outcomes (3)
Early Recurrence of Warts
Recurrence of warts at previously cleared sites in participants who achieved complete clearance, assessed by clinical examination during follow-up visits.
Measured: Up to 3 months from baseline
Adverse Effects of Treatment
Occurrence of treatment-related adverse effects including pain at injection site, erythema (redness), swelling, ulceration, or scarring. Documented systematically at each follow-up visit.
Measured: Up to 3 months from baseline
Number of Treatment Sessions Required for Complete Clearance
The number of intralesional injection sessions (out of a maximum of four) needed to achieve complete clearance of warts, compared between the two treatment groups.
Measured: 8 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start20 Feb 2026
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral WartStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatima Sajid, FCPS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448844
- Sponsor's protocol ID
- Riphah/IRB/26/1041
- Status last verified
- Aug 2026
- First submitted
- 26 Feb 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Therapies For Cutaneous Viral Warts: A Comparative Analysis Of Vitamin D3 And Acyclovir
- ClinicalTrials.gov ID
- NCT07448844
- Acronym / sponsor ID
- Riphah/IRB/26/1041
- Conditions
- Viral Wart, Plantar Wart, Common Warts (Verruca Vulgaris), Common Wart, Flat Wart, Warts of Foot
- Keywords
- Cutaneous warts, intralesional therapy, treatment efficacy, plantar warts, common warts, human papillomavirus, randomized controlled trial, vitamin D3
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 4 Mar 2026 (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 learn if injecting acyclovir (an antiviral drug) or vitamin D3 directly into skin warts works to clear them in people aged 12 and older with common, plantar, flat, or periungual (around the nail) warts. The main questions it aims to answer are:
- Does intralesional acyclovir or vitamin D3 lead to complete clearance of warts by week 8?
- Which treatment clears warts more effectively?
- What side effects do participants have with each treatment?
Researchers will compare acyclovir injections (Group A) to vitamin D3 injections (Group B), with 20 participants in each group, to see which treatment works better at clearing warts.
Participants will:
- Receive an injection directly into the wart every 2 weeks for up to 4 sessions
- Have photographs taken of their warts before treatment and at each visit
- Visit the clinic for checkups where the size and number of warts will be measured
- Be followed for up to 3 months to check for wart recurrence and side effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intralesional Acyclovir | Experimental | Drug: Intralesional AcyclovirParticipants receive intralesional injection of acyclovir. Injections are administered at baseline and repeated every 2 weeks for a maximum of four sessions. |
| Intralesional Vitamin D3 | Active comparator | Drug: Intralesional Vitamin D3Participants receive intralesional injection of vitamin D3 (200,000 IU). Injections are administered at baseline and repeated every 2 weeks for a maximum of four sessions. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 12 years and above with clinically diagnosed cutaneous warts
- Common, plantar, flat, or periungual warts
- Both treatment-naïve patients and those with recalcitrant warts
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Immunocompromised patients
- Individuals with history of hypersensitivity to vitamin D3 or acyclovir
- Individuals receiving systemic immunosuppressive or antiviral therapy
- Patients with secondary infection at injection site
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 AcyclovirAcyclovir (70 mg/mL) prepared by reconstituting a 250 mg vial with 3.5 mL of distilled water, injected directly into the wart lesion. Dosing is based on lesion size: 0.2 mL for warts ≤0.5 cm, 0.3-0.5 mL for 0.5-1 cm, and 0.5-1 mL for 1-1.5 cm. Administered at baseline and every 2 weeks for up to four sessions. | Drug | Intralesional Acyclovir |
| Intralesional Vitamin D3Vitamin D3 (200,000 IU; 5 mg/mL) injected directly into the wart lesion. Dosing is based on lesion size: 0.2 mL for warts ≤0.5 cm, 0.3-0.5 mL for 0.5-1 cm, and 0.5-1 mL for 1-1.5 cm. Administered at baseline and every 2 weeks for up to four sessions. | Drug | Intralesional Vitamin D3 |
Primary outcome
Clinical Response at Week 8
Time frame: 8 weeks from baseline
Clinical response categorized as complete clearance (100% resolution of wart), partial response (reduction in size or number of warts but not complete clearance), or no response (no change or increase in size or number of warts). Assessed by an independent blinded investigator using clinical examination and standardized digital photographs.
3 secondary outcomes
Early Recurrence of Warts
Time frame: Up to 3 months from baseline
Adverse Effects of Treatment
Time frame: Up to 3 months from baseline
Number of Treatment Sessions Required for Complete Clearance
Time frame: 8 weeks from baseline
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 7 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Fatima Sajid, FCPS principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intralesional Acyclovir and Intralesional Vitamin D3 in people with Viral Wart and Plantar Wart, run by Riphah International University at 2 sites in Pakistan.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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.
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?
Contact Fatima Sajid, FCPS (+92 334 435 2228, fatima.sajid@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Response at Week 8 (time frame: 8 weeks from baseline). 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 7 Aug 2026.