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

Phase 2

Recruiting

• Conditions: Plantar Wart
• Interventions: Device: Cryotherapy; Drug: Intralesional Acyclovir

• Registration Number: NCT06261684
• Lead Sponsor: Cairo University

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-10-06
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryotherapy	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
Intralesional Acyclovir	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.

Primary Outcome Measures

Name	Time	Method
Cure rate	10 weeks (5 sessions max)	Number of patients healed after completion of the sessions
Patient satisfaction score	10 weeks	Patient satisfaction questionnaire score
Recurrence rate	24 weeks	Number of patients had recurred plantar warts after receiving the treatment

Secondary Outcome Measures

Name	Time	Method
Correlation of treatment with gender	10 weeks	Percentage of successfully treated male to female patients
Correlation of treatment with age	10 weeks	Percentage of patients successfully treated in each age group (Young 18-32 years; Middle age 33-46, Old age 47-60
Correlation of treatment with number of ipsilateral warts	10 weeks	Number of warts increased, decreased or stationary
Correlation of treatment with size of the wart	10 weeks	Percentage of successful treatment compared to the size of the wart

Trial Locations

Locations (1)

Cairo University Hospital; 🇪🇬 Cairo, Egypt