Warts of FootLAVsCryWartsNCT06228521
Efficacy & Safety of 980nm Diode Laser vs. Cryotherapy for Plantar Warts
A study testing Liquid nitrogen sprayed and 980nm diode laser applied in people with Warts of Foot, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Warts of Foot
- What is being tested?
- Liquid nitrogen sprayed and 980nm diode laser applied
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2024to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with recalcitrant, mosaic and simple HPV
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Efficacy and Safety of 980nm Diode Laser Versus Liquid Nitrogen Cryotherapy for the Treatment of 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?
Read more
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
Read the 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.
- Conditions
- Warts of Foot
- Being tested
- Liquid nitrogen sprayed, 980nm diode laser applied
- Keywords
- cryotherapy, laser therapy, papillomaviridae, plantar warts, randomised clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid nitrogen sprayedOther
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 appliedOther
980nm diode laser applied to each wart for 5 seconds at 2W power and 1mm spot size. 4 sessions at weekly intervals.
| Study group | Role | What they receive |
|---|---|---|
| Laser Group | Experimental | LASEmaR MINI 980 nm Receives: Other: 980nm diode laser applied |
| Cryotherapy group: | Active comparator | CryoIQ Receives: Other: Liquid nitrogen sprayed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 days from first application
Secondary outcomes (2)
VAS scale
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.
Measured: 7 days from first application
complications
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.
Measured: 7 days from first application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Feb 2024
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Warts of FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente Mártir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Ferrer-Torregrosa, Dr., Study director, FundaciónUcv
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228521
- Sponsor's protocol ID
- UCV/2022-2023/080
- Acronym
- LAVsCryWarts
- Status last verified
- Apr 2024
- First submitted
- 19 Jan 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33031838
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 980nm Diode Laser Versus Liquid Nitrogen Cryotherapy for the Treatment of Plantar Warts
- ClinicalTrials.gov ID
- NCT06228521
- Acronym / sponsor ID
- LAVsCryWarts / UCV/2022-2023/080
- Conditions
- Warts of Foot
- Keywords
- cryotherapy, laser therapy, papillomaviridae, plantar warts, randomised clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente MártirUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Group | Experimental | Other: 980nm diode laser appliedLASEmaR MINI 980 nm |
| Cryotherapy group: | Active comparator | Other: Liquid nitrogen sprayedCryoIQ |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with recalcitrant, mosaic and simple HPV
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid nitrogen sprayedLiquid 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. | Other | Cryotherapy group: |
| 980nm diode laser applied980nm diode laser applied to each wart for 5 seconds at 2W power and 1mm spot size. 4 sessions at weekly intervals. | Other | Laser Group |
Primary outcome
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).
2 secondary outcomes
VAS scale
Time frame: 7 days from first application
complications
Time frame: 7 days from first application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Results publication: PubMed 33031838Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Ferrer-Torregrosa, Dr. study director
FundaciónUcv
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid nitrogen sprayed and 980nm diode laser applied in people with Warts of Foot, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin pattern (time frame: 7 days from first application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06228521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.