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Not yet recruiting NCT07196670

Intralesional Vitamin D Versus Intralesional Acyclovir in Plantar Warts

Phase IV Interventional Plantar Warts Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intralesional vitamin D3 versus intralesional acyclovir.
Who it may be relevant to
Registry conditions: Plantar Warts Treatment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Intralesional Vitamin D Versus Intralesional Acyclovir in Plantar Warts: a Single-blinded Randomized Clinical Trial With Clinico-dermoscopic Evaluation

Overview

The goal of this clinical trial is to compare intralesional vitamin D versus intralesional acyclovir in the treatment of plantar warts. It will also learn about the safety of both techniques. The main questions it aims to answer are: which is more effective in the treatment of plantar warts? What medical problems do participants have when taking both? What is the recurrence rate in both treatment modalities? Participants will:• Sixty plantar warts patients will be included in this study. * They will be randomly allocated into two groups: intralesional vitamin D group (group A) and intralesional Acyclovir group (group B). Patients will be blinded to their therapeutic arm. * All patients will be subjected to the following: 1. Proper history taking and physical examination. Number and size of warts shall be noted. 2. Informed consent 3. Dermoscopic evaluation of the lesions by Fotofinder Medicam 800HD dermoscope 4. Digital photography of the lesions * Group A: The aqueous solution of vitamin D3 is used (Devarol S 200,000IU/2ml ) 0.6 ml (60,000 IU ) will be slowly injected into the base of the largest wart Injections will be repeated at 3 week intervals till resolution of warts or for a maximum of 4 sessions Any hyperkeratotic lesions will be pared before injection • Group B: Acyclovir vial (250 mg) will be diluted with 3.5 ml saline to get approximately 70 mg/ml solution 0.1 ml will be slowly injected into the base of the largest wart Injections will be repeated at 3 week intervals till resolution of warts or for a maximum of 4 sessions Any hyperkeratotic lesion will be pared before injection • Follow up: After cessation of treatment, there will be one month follow up during which: * Patient will be questioned about side effects * Physical examination to check response and/or detect recurrence * Photography in the same positions * Size of the warts shall be noted * Number of warts shall be noted * Dermoscopic evaluation: Patients will be examined with Fotofinder Medicam 800HD dermoscope Assessment of size and percentage of red dots and linear vessels per field At baseline, then after completion of treatment sessions and finally after 1 month from the last treatment session. • Based on clinical, photographic and dermoscopic data, response will be graded by a blinded observer as follows: Complete response (100% disappearance of warts) Partial response (50-\<100% decrease in wart size) No response (\<50% decrease in wart size)

Interventions

  • Drug intralesional vitamin D3 versus intralesional acyclovir
    injecting intralesional vitamin D in group A versus injecting intralesional acyclovir in group B in treatment of plantar warts

Primary outcome measures

  • comparing the percentage of decrease in size and number of plantar warts after intralesional vitamin D versus intralesional acyclovir [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • patients with plantar warts, both sex, above 18 years old

Exclusion criteria

  • under 18 years old, hypersensitivity to vitamin D or intralesional acyclovir, patients on systemic acyclovir and vitamin D, pregnant or lactating females, cognitively impaired patients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07196670 · CairoUniversityKasralainy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗