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Recruiting NCT07448844

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

Phase IV Interventional Viral Wart Plantar Wart Common Warts (Verruca Vulgaris) Common Wart

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intralesional Acyclovir, Intralesional Vitamin D3.
Who it may be relevant to
Registry conditions: Viral Wart, Plantar Wart, Common Warts (Verruca Vulgaris), Common Wart. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Clinical Response at Week 8 [Time frame: 8 weeks from baseline]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 2 centers
  • Railway General Hospital, Railway Carriage Factory Rd, Railway Scheme 7, Rawalpindi — Rawalpindi
  • Riphah International Hospital, Islamabad Expy, Sector A DHA Phase 5, Islamabad — Islamabad

Identifiers

NCT: NCT07448844 · Riphah/IRB/26/1041

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗