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RecruitingNCT07448844Updated Aug 7, 2026

Intralesional Therapies For Cutaneous Viral Warts: A Comparative Analysis Of Vitamin D3 And Acyclovir

A Phase 4 interventional study of Intralesional Acyclovir and Intralesional Vitamin D3 in Viral Wart, Plantar Wart and Common Warts (Verruca Vulgaris), sponsored by Riphah International University. Recruiting at 2 sites in Pakistan. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Riphah International University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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. Does intralesional acyclovir or vitamin D3 lead to complete clearance of warts by week 8?
  2. Which treatment clears warts more effectively?
  3. 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:

  1. Receive an injection directly into the wart every 2 weeks for up to 4 sessions
  2. Have photographs taken of their warts before treatment and at each visit
  3. Visit the clinic for checkups where the size and number of warts will be measured
  4. Be followed for up to 3 months to check for wart recurrence and side effects
02

Conditions studied

  • Viral Wart
  • Plantar Wart
  • Common Warts (Verruca Vulgaris)
  • Common Wart
  • Flat Wart
  • Warts of Foot
  • Warts Hand
  • Wart

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Keywords

  • Cutaneous warts
  • intralesional therapy
  • treatment efficacy
  • plantar warts
  • common warts
  • human papillomavirus
  • randomized controlled trial
  • vitamin D3
  • acyclovir
  • flat warts
03

In context

Warts

171 studies on the registry are indexed under Warts; 35 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 155 interventional studies indexed under Warts.

Browse Warts studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.

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

04

Who can participate

Ages eligible
12 Years and older
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

  • 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

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women
  • patients
  • Individuals with history of 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
Terms in these criteria, in plain language(2)

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.

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Intralesional Acyclovir

    Participants receive intralesional injection of acyclovir. Injections are administered at baseline and repeated every 2 weeks for a maximum of four sessions.

    Drug: Intralesional Acyclovir

  • Active comparator
    Intralesional Vitamin D3

    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.

    Drug: Intralesional Vitamin D3

Interventions

  • DrugIntralesional Acyclovir

    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.

  • DrugIntralesional Vitamin D3

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks from baseline

Secondary outcomes

  1. 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.

    Time frame: Up to 3 months from baseline

  2. 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.

    Time frame: Up to 3 months from baseline

  3. 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.

    Time frame: 8 weeks from baseline

07

Study locations

2 of 2 sites recruiting
  • Railway General Hospital, Railway Carriage Factory Rd, Railway Scheme 7, Rawalpindi
    Rawalpindi, Punjab Province 46000, Pakistan
    Recruiting
  • Riphah International Hospital, Islamabad Expy, Sector A DHA Phase 5, Islamabad
    Islamabad, 44000, Pakistan
    Recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07448844
Responsible party
Sponsor
First posted
Mar 4, 2026
Start date
Feb 20, 2026
Primary completion
Sep 20, 2026 (estimated)
Completion
Sep 20, 2026 (estimated)
Last update
Aug 7, 2026

Study contacts

Fatima Sajid, FCPS
Contact
fatima.sajid@riphah.edu.pk
+92 334 435 2228
Fatima Sajid, FCPS
principal investigator · Riphah International University

Oversight

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

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