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

NCT07448844 — Phase 4, Recruiting, 40 participants, Riphah International University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07448844
Status	Recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	40 (Estimated)
Sponsor	Riphah International University (Other)
Conditions	Viral Wart, Plantar Wart, Common Warts (Verruca Vulgaris), Common Wart, Flat Wart, Warts of Foot, Warts Hand, Wart
Interventions	Intralesional Acyclovir, Intralesional Vitamin D3 (Drug)
Dates	start 2026-02-20, primary completion 2026-09-20 (estimated), completion 2026-09-20 (estimated), first posted 2026-03-04, last updated 2026-08-07
Locations	2 sites in Pakistan

-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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Intralesional Acyclovir	Experimental	Drug: Intralesional Acyclovir	Participants 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 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.

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 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.

+Outcome measures

Primary outcomes

Clinical Response at Week 8 [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.

Secondary outcomes

Early Recurrence of Warts [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.
Adverse Effects of Treatment [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.
Number of Treatment Sessions Required for Complete Clearance [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.

+Eligibility

Sex: All, ages: 12 Years to any

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

+Locations (2)

Facility	City	Country	Status
Railway General Hospital, Railway Carriage Factory Rd, Railway Scheme 7, Rawalpindi	Rawalpindi, Punjab Province	Pakistan	Recruiting
Riphah International Hospital, Islamabad Expy, Sector A DHA Phase 5, Islamabad	Islamabad	Pakistan	Recruiting

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2025-12-15)
Informed Consent Form (PDF, 2025-12-15)

+Investigators

Fatima Sajid, FCPS, Principal investigator, Riphah International University