Clinical trial NCT06228521: Efficacy & Safety of 980nm Diode Laser vs. Cryotherapy for Plantar Warts
Official title: Efficacy and Safety of 980nm Diode Laser Versus Liquid Nitrogen Cryotherapy for the Treatment of Plantar Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Warts of Foot
Keywords: cryotherapy
laser therapy
papillomaviridae
plantar warts
randomised clinical trial
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Skin pattern
timeFrame: 7 days from first application
Secondary outcomes:
measure: VAS scale
timeFrame: 7 days from first application
measure: complications
timeFrame: 7 days from first application
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Studio di Podologia Dr.Secolo
state: Sicilia
city: Valencia
country: Spain
facility: Clinicas UCV
state: València
Study officials:
affiliation: FundaciónUcv
name: Javier Ferrer-Torregrosa, Dr.
role: STUDY_DIRECTOR
References:
citation: Liu JJ, Li HT, Ren YY, Yang F, Cheng ZH, Xia TB, Liu JL, Cao XJ, Lu SC. Long-pulsed neodymium-doped yttrium-aluminum-garnet laser versus cryotherapy for the treatment of cutaneous warts: A randomized controlled trial. J Am Acad Dermatol. 2022 Dec;87(6):1328-1335. doi: 10.1016/j.jaad.2020.09.085. Epub 2020 Oct 5.