Warts of Foot
Conditions
Keywords
cryotherapy, laser therapy, papillomaviridae, plantar warts, randomised clinical trial
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.
Interventions
OTHERLiquid 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.
OTHER980nm 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.
Sponsors
Fundación Universidad Católica de Valencia San Vicente Mártir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin pattern | 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
| Measure | Time frame | Description |
|---|---|---|
| VAS scale | 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. |
| complications | 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. |
Countries
Italy, Spain
Outcome results
None listed