Common Wart, Common Warts (Verruca Vulgaris), Flat Wart, Plantar Wart, Viral Wart, Wart, Warts Hand, Warts of Foot
Conditions
Keywords
Cutaneous warts, intralesional therapy, treatment efficacy, plantar warts, common warts, human papillomavirus, randomized controlled trial, vitamin D3, acyclovir, flat warts
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. 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
Interventions
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.
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.
Sponsors
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Pakistan
Contacts
CONTACTFatima Sajid, FCPS
PRINCIPAL_INVESTIGATORFatima Sajid, FCPS
Riphah International University
Outcome results
None listed