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

Phase 4RecruitingNCT07448844

Riphah International University40 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Viral Wart Plantar Wart Common Warts (Verruca Vulgaris)

Interventions

Intralesional AcyclovirDRUG

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 D3DRUG

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.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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)

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

Outcomes

Primary Outcomes

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

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

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

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