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

February 13, 2024 updated by: Basant Ahmed Mohamed Abdelaal Helal, Cairo University

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Cairo University Hospital
        • Contact:
          • Basant Helal, MRCP
        • Principal Investigator:
          • Shahira Ramadan, Professor
        • Sub-Investigator:
          • Yousra Azzazi, Lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Intralesional Acyclovir
Intralesional Acyclovir in plantar warts
Active Comparator: 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
Device: Cryotherapy
Cryotherapy of plantar warts

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Shahira Ramadan, Professor, Cairo university
  • Study Director: Yousra Azzazi, Lecturer, Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-259-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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