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

Обзор

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

Вмешательства

• Препарат Intralesional Acyclovir
  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.
• Препарат Intralesional Vitamin D3
  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.

Первичные конечные точки

• Clinical Response at Week 8 [Срок оценки: 8 weeks from baseline]

Вторичные конечные точки (3)

• Early Recurrence of Warts [Срок оценки: Up to 3 months from baseline]
• Adverse Effects of Treatment [Срок оценки: Up to 3 months from baseline]
• Number of Treatment Sessions Required for Complete Clearance [Срок оценки: 8 weeks from baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 2 центра

• Railway General Hospital, Railway Carriage Factory Rd, Railway Scheme 7, Rawalpindi — Rawalpindi
• Riphah International Hospital, Islamabad Expy, Sector A DHA Phase 5, Islamabad — Islamabad

Идентификаторы

NCT: NCT07448844 · Riphah/IRB/26/1041

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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