Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-10-01

Brief Summary

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The goal of this prospective randomized controlled study is to study the safety and efficacy of intralesional acyclovir compared to cryotherapy in plantar warts. The main questions needed to be answered are:

1. Is Intralesional acyclovir safe for plantar warts?
2. Is Intralesional acyclovir more efficient in treating plantar warts compared to cryotherapy?

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Detailed Description

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Conditions

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Plantar Wart

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intralesional Acyclovir

Intralesional acyclovir will be prepared by diluting 1 ampoule of Acyclovir 250mg into 3.5ml of saline solution to achieve a concentration of approximately 70mg/ml. Then 0.1ml will be injected intra-lesionally into the base of the wart. Any hyperkeratotic lesions should be pared before the treatment. This process will be repeated every 2 weeks for 5 sessions, and can be discontinued if complete resolution is achieved early.

Group Type EXPERIMENTAL

Intralesional Acyclovir

Intervention Type DRUG

Intralesional Acyclovir in plantar warts

Cryotherapy

Patients allocated to Group B will undergo cryotherapy using a liquid nitrogen spray gun. Any hyperkeratotic lesions should be pared before the treatment. Two freeze-thaw cycles will be applied each session, the spray gun should be held 1cm away from the wart and maintained until the wart and the 1-3mm of surrounding skin shows freezing, and each cycle should last 15 seconds. Next, the lesion will be left to thaw completely before starting the second cycle. This process will be repeated every 2 weeks for 5 sessions, and can be discontinued if complete resolution is achieved early

Group Type ACTIVE_COMPARATOR

Cryotherapy

Intervention Type DEVICE

Cryotherapy of plantar warts

Interventions

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Intralesional Acyclovir

Intralesional Acyclovir in plantar warts

Intervention Type DRUG

Cryotherapy

Cryotherapy of plantar warts

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 years or older, of both genders, with plantar warts

Exclusion Criteria

* Patients on systemic treatment for warts eg. Acitretin, Acyclovir
* Hypersensitivity to Acyclovir
* Previous treatment to the same wart during the last 3 months
* Immunocompromised patients (as HIV, steroid intake, uncontrolled diabetes, etc.)
* Pregnant and breastfeeding females
* Cognitively impaired patients

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No