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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralesional Acyclovir | Experimental | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 3 months from baseline |
| Adverse Effects of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Railway General Hospital, Railway Carriage Factory Rd, Railway Scheme 7, Rawalpindi | Recruiting | Rawalpindi | Punjab Province | 46000 | Pakistan |
A decision regarding IPD sharing has not yet been made. Requests for data may be considered on a case-by-case basis by contacting the principal investigator.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2025 |
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|
| 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. |
|
Occurrence of treatment-related adverse effects including pain at injection site, erythema (redness), swelling, ulceration, or scarring. Documented systematically at each follow-up visit.
| 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. | 8 weeks from baseline |
| Riphah International Hospital, Islamabad Expy, Sector A DHA Phase 5, Islamabad | Recruiting | Islamabad | 44000 | Pakistan |
|
| Feb 26, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2025 | Feb 26, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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