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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Warts of Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Laser Group

LASEmaR MINI 980 nm

Group Type EXPERIMENTAL

980nm diode laser applied

Intervention Type OTHER

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

Cryotherapy group:

CryoIQ

Group Type ACTIVE_COMPARATOR

Liquid nitrogen sprayed

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No