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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Intralesional Acyclovir
DrugAcyclovir (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
DrugVitamin 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
Trial 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.
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.
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.
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.
Sponsors and contacts
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