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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12+
SponsorRiphah International University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant or lactating women

Immunocompromised patients

Individuals with history of hypersensitivity to vitamin D3 or acyclovir

Individuals receiving systemic immunosuppressive or antiviral therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intralesional AcyclovirExperimental treatment 1 intervention
Group B: Intralesional Vitamin D3Active comparator 1 intervention

Trial outcomes

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.

Time frame
8 weeks from baseline

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

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