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

NCT07448844 | Recruiting Phase 4

• 1 other identifier: Riphah/IRB/26/1041
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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. 1.Does intralesional acyclovir or vitamin D3 lead to complete clearance of warts by week 8?
2. 2.Which treatment clears warts more effectively?
3. 3.What side effects do participants have with each treatment?
4. 4.Receive an injection directly into the wart every 2 weeks for up to 4 sessions
5. 5.Have photographs taken of their warts before treatment and at each visit
6. 6.Visit the clinic for checkups where the size and number of warts will be measured
7. 7.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; Warts Hand; Wart

Keywords

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

Outcome Measures

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.

  8 weeks from baseline

Secondary Outcomes (3)

• Early Recurrence of Warts

  Up to 3 months from baseline

• Adverse Effects of Treatment

  Up to 3 months from baseline

• Number of Treatment Sessions Required for Complete Clearance

  8 weeks from baseline

Study Arms (2)

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.

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.

Drug: Intralesional Vitamin D3

Interventions

Intralesional Acyclovir DRUG

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 Acyclovir

Intralesional Vitamin D3 DRUG

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.

Intralesional Vitamin D3

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

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

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: February 20, 2026
• Primary Completion: May 20, 2026
• Study Completion: May 20, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

PA (2)