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

Cairo University (CU)

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Plantar Wart

Treatments: Device: Cryotherapy; Drug: Intralesional Acyclovir

Study type: Interventional

Funder types: Other

Identifiers

NCT06261684

MS-259-2023

Details and patient eligibility

About

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?

Enrollment: 92 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups

Intralesional Acyclovir

Experimental group

Description:

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.

Treatment:

Drug: Intralesional Acyclovir

Cryotherapy

Active Comparator group

Description:

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

Treatment:

Device: Cryotherapy