Efficacy & Safety of 980nm Diode Laser vs. Cryotherapy for Plantar Warts (LAVsCryWarts)

April 22, 2024 updated by: Fundación Universidad Católica de Valencia San Vicente Mártir

Efficacy and Safety of 980nm Diode Laser Versus Liquid Nitrogen Cryotherapy for the Treatment of Plantar Warts

The goal of this clinical trial is to compare and test the efficacy of two treatments for plantar warts. The main questions it aims to answer are:

Which treatment has a higher cure rate for eliminating plantar warts? Which treatment causes less pain during the procedure?

Participants with plantar warts will:

Be randomly assigned to receive either cryotherapy or laser therapy Undergo 4 treatment sessions at weekly intervals Have their warts assessed for complete clearance after treatment Rate their pain levels during each session

Researchers will compare the cryotherapy and laser therapy groups to see if there are differences in:

Rates of complete wart clearance Pain levels reported during treatment Adverse effects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Plantar warts are a common dermatological condition caused by human papillomavirus infection. They can be painful and negatively impact quality of life. Many treatments exist but there is lack of consensus on the optimal approach.

Objectives:

Primary objective: To compare the efficacy of 980nm diode laser versus liquid nitrogen cryotherapy for clearing plantar warts, as measured by the complete clearance rate at 4 weeks post-treatment.

Secondary objectives: To evaluate and compare pain levels during treatment procedures and adverse events between both groups.

Study design: Randomized, double-blind clinical trial.

Participants: 32 patients aged 18-65 years old with 1-3 plantar warts located on weight-bearing areas of the foot.

Interventions:

Laser group: 980nm diode laser applied to each wart for 5 seconds at 2W power and 1mm spot size. 4 sessions at weekly intervals.

Cryotherapy group: Liquid nitrogen sprayed on each wart using a standardised technique. Freeze-thaw cycle repeated up to 3 times per wart per session. 4 sessions at weekly intervals.

Main outcomes:

Complete clearance rate of plantar warts at 4 weeks treatment session. Assessed by physical examination.

Pain during procedure measured with Visual Analogue Scale (VAS). Adverse events monitored during follow-up.

Randomization and blinding: Subjects will be randomly allocated to each group with a 1:1 ratio. Investigators assessing outcomes will be blinded to group assignment.

Analysis: Intention-to-treat analysis will be performed. Chi-squared test will compare clearance rates. T-test will compare pain scores.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Italy
    • Sicilia
      • Catania, Sicilia, Italy, 95128
        • Studio di Podologia Dr.Secolo
  • Spain
    • València
      • Valencia, València, Spain, 46001
        • Clinicas UCV

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with recalcitrant, mosaic and simple HPV

Exclusion Criteria:

  • Diabetic, ischaemic and immunosuppressed patients
  • Patients with cold intolerance
  • Patients with any of the following conditions (blood dyscrasias of unknown origin, cryoglobulinaemia, cryofibrinogenemia, collagen or autoimmune disease)
  • Patients who do not sign the informed consent form.

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: Laser Group
LASEmaR MINI 980 nm
Other: 980nm diode laser applied
980nm diode laser applied to each wart for 5 seconds at 2W power and 1mm spot size. 4 sessions at weekly intervals.
Active Comparator: Cryotherapy group:
CryoIQ
Other: Liquid nitrogen sprayed
Liquid nitrogen sprayed on each wart using a standardised technique. Freeze-thaw cycle repeated up to 3 times per wart per session. 4 sessions at weekly intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin pattern
Time Frame: 7 days from first application
Interrupted plantar lines with irregularly distributed dots.classifies the severity in 3 degrees, from the absence of alterations (0) to the extensive presence of interrupted lines and irregular spots in the plantar skin pattern (3).
7 days from first application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS scale
Time Frame: 7 days from first application
It is a tool to allow the patient to evaluate the intensity of the pain on a visual scale of 0-10, where 0 is nothing and 10 is unbearable, being a subjective evaluation.
7 days from first application
complications
Time Frame: 7 days from first application
complications including the possibility of recurrence, discomfort or pain during or after treatment, risk of infection at the treated site, potential for scarring or changes in skin appearance, hypersensitivity or allergies to the drugs used, changes in skin pigmentation, and in rare cases, possibility of damage to surrounding structures such as nerves or blood vessels.
7 days from first application

Collaborators and Investigators

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

Sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Investigators

  • Study Director: Javier Ferrer-Torregrosa, Dr., FundaciónUcv

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)

February 1, 2024

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCV/2022-2023/080

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.

Clinical Trials on Warts of Foot

Clinical Trials on 980nm diode laser applied

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe