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

NCT06228521 | Completed

• 1 other identifier: UCV/2022-2023/080
• Study Type: interventional
• Target: 44
• Locations: 2 countries
• Sites: 2

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

Conditions

Warts of Foot

Keywords

cryotherapy; laser therapy; papillomaviridae; plantar warts; randomised clinical trial

Outcome Measures

Primary Outcomes (1)

• Skin pattern

  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 Outcomes (2)

• VAS scale

  7 days from first application

• complications

  7 days from first application

Study Arms (2)

Laser Group

EXPERIMENTAL

LASEmaR MINI 980 nm

Other: 980nm diode laser applied

Cryotherapy group:

ACTIVE COMPARATOR

CryoIQ

Other: Liquid nitrogen sprayed

Interventions

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.

Cryotherapy group:

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.

Laser Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with recalcitrant, mosaic and simple HPV

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (2)

Studio di Podologia Dr.Secolo

Catania, Sicily, 95128, Italy

Location

Clinicas UCV

Valencia, València, 46001, Spain

Location

Related Publications (1)

• 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.

  PMID: 33031838 RESULT

Study Officials

• Javier Ferrer-Torregrosa, Dr.

  FundaciónUcv

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: February 1, 2024
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

IT (1); ES (1)