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

March 6, 2026 updated by: Fatima Sajid, Riphah International University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Recruiting
        • Riphah International Hospital, Islamabad Expy, Sector A DHA Phase 5, Islamabad
        • Contact:
        • Principal Investigator:
          • Fatima Sajid, MBBS, FCPS (Derm)
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 46000
        • Recruiting
        • Railway General Hospital, Railway Carriage Factory Rd, Railway Scheme 7, Rawalpindi
        • Contact:
        • Principal Investigator:
          • Nadia Ghazanfar, MBBS, FCPS (Derm)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Recurrence of Warts
Time Frame: Up to 3 months from baseline
Recurrence of warts at previously cleared sites in participants who achieved complete clearance, assessed by clinical examination during follow-up visits.
Up to 3 months from baseline
Adverse Effects of Treatment
Time Frame: Up to 3 months from baseline
Occurrence of treatment-related adverse effects including pain at injection site, erythema (redness), swelling, ulceration, or scarring. Documented systematically at each follow-up visit.
Up to 3 months from baseline
Number of Treatment Sessions Required for Complete Clearance
Time Frame: 8 weeks from baseline
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.
8 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2026

Primary Completion (Estimated)

May 20, 2026

Study Completion (Estimated)

May 20, 2026

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Riphah/IRB/26/1041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A decision regarding IPD sharing has not yet been made. Requests for data may be considered on a case-by-case basis by contacting the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Plantar Wart

Clinical Trials on Intralesional Acyclovir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe