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Completed

NCT Number: NCT06228521

Efficacy & Safety of 980nm Diode Laser vs. Cryotherapy for 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

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Key information

Conditions

Warts of Foot

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Studio di Podologia Dr.Secolo, Catania, Sicily, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liquid nitrogen sprayed

Other

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.

980nm diode laser applied

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Other

Registry information

Official study title

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

Acronym: LAVsCryWarts

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2024
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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