Plantar WartNCT04654091
Cryotherapy VS. Nitric-zinc Complex in the Treatment of Plantar Warts.
A study testing Cryoteraphy with liquid nitrogen and Nitric-zinc complex in people with Plantar Wart, run by Universidad Complutense de Madrid.
Trial summary
Plantar warts are benign skin lesions caused by human papillomavirus (HPV).There are several treatment methods for this illness, but none of them can heal all patients. Cryotherapy using liquid nitrogen is one of the most common local treatments. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Plantar Wart
- What is being tested?
- Cryoteraphy with liquid nitrogen and Nitric-zinc complex
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects older than 12 years.
- Patients diagnosed with recalcitrant or non-recalcitrant plantar wart.
Who cannot join
- Diagnosis of Diabetes Mellitus.
- Peripheral vascular disease.
- Patients with an immune system disorder or in immunosuppressants treatment.
- Peripheral or central neuropathy.
- Coagulation disorders.
- Raynaud's disease or some alteration of the perception of cold or heat.
- Alterations in healing for wounds or in the synthesis of collagen.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cryotherapy With Liquid Nitrogen and Nitric-zinc Complex in the Treatment of Plantar Warts. Randomised Controlled Trial.
Plantar warts are benign skin lesions caused by human papillomavirus (HPV).There are several treatment methods for this illness, but none of them can heal all patients. Cryotherapy using liquid nitrogen is one of the most common local treatments. In this study, we will compare the effectiveness of cryotherapy with liquid nitrogen with the association of organic acids and nitric acid (nitric-zinc complex). In addition, as secondary objectives have been defined: 1) know the number of applications necessary for each treatment to achieve the complete resolution of the plantar wart, in order to compare the healing times between each treatment and establish which treatment is faster, 2) analyze the influence of the HPV biotype, the location of the lesion and the time of evolution in the response to the different treatments, and 3) Compare the ultrasound signs of plantar warts with the ultrasound signs of healthy skin after the resolution of the process.
Read the detailed description
A randomized controlled clinical trial is proposed. The recruitment of patients will be carried out by including the sample of those patients who have diagnostic confirmation of plantar wart in the Chiropodology and Surgery Service of the University Podiatry Clinic of the Complutense University of Madrid, consecutively, between November 2020 and the date when the estimated sample size is reached.
Participants in the trial will be assigned with equal probability to each treatment arm, based on their consecutive inclusion in the study. Subsequently, the treatment allocation will be determined by a random code generated by the Epidat 4.1 program using random permuted blocks. The treatment used will be evident both for the participant and for the research podiatrist responsible for the intervention. However, the primary result will be confirmed by the microbiological study carried out by the Department of Microbiology of the Complutense University of Madrid, which does not know any data about the patient or the treatment group to which it was initially assigned.
- Conditions
- Plantar Wart
- Being tested
- Cryoteraphy with liquid nitrogen, Nitric-zinc complex
- Keywords
- plantar wart, nitric acid, cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoteraphy with liquid nitrogenProcedure or surgery
Weekly, at each visit, before applying the treatment, a debridement of the hyperkeratotic tissue covering the wart will be performed with a scalpel handle of number 3 and a scalpel blade of number 15, and then the treatment will be applied.
Subsequently, the application of cryotherapy with liquid nitrogen will be carried out using CryoPen b® (HO Equipment, Hhislenghien-Belgium). To analyze the homogeneous application in all the patients in the study, perform 2 applications of 15 seconds per session, with an interval of 30 seconds between each application, such and as manufacturers recommend. The number of sessions in which the product is applied will be a maximum of 5, following the procedure of previous studies.
Nitric-zinc complexProcedure or surgery
Weekly, at each visit, before applying the treatment, a debridement of the hyperkeratotic tissue covering the wart will be performed with a scalpel handle of number 3 and a scalpel blade of number 15, and then the treatment will be applied.
Subsequently, the application of nitric acid-zinc complex with Verrutop® (Isdin, Barcelona-Spain) will be carried out. The preparation is applied by making small touches with the applicators included in the product.
The number of sessions in which the product is applied will be a maximum of 5, following the recommendations of the manufacturers in the product data sheet.
| Study group | Role | What they receive |
|---|---|---|
| Cryoteraphy with liquid nitrogen | Experimental | Patients older than 18 years with a diagnosis of plantar wart, who have agreed to participate in the study. Receives: Procedure: Cryoteraphy with liquid nitrogen |
| Nitric-zinc complex | Experimental | Patients older than 18 years with a diagnosis of plantar wart, who have agreed to participate in the study. Receives: Procedure: Nitric-zinc complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cryotherapy efficacy versus nitric-zinc complex
Compare the cure rates of the following topical treatments of plantar warts: cryotherapy with liquid nitrogen; and the association of organic acids and nitric acid (nitric-zinc complex), in a period of 12 weeks.
A polymerase chain reaction (PCR) test will be performed when there is an absence of clinical signs and symptoms of plantar wart, considering cure when a negative result is obtained.
In those patients in whom the maximum number of treatment sessions recommended in the technical sheet of each product has been carried out and clinical signs of plantar wart are still observed, as well as in those patients who after 12 weeks of follow-up continue to present signs and symptoms Clinicians will be considered as not cured, considering the study ended.
Measured: One year approximately
Secondary outcomes (3)
Number of applications
Know the number of applications needed for each treatment to achieve full resolution of the plantar wart, a fin to compare the healing times between each treatment and establish which treatment is faster.
Measured: One year approximately
Influence of the characteristics of the lesion
To analyze the influence of the HPV biotype, the location of the lesion and the time of evolution in the response to the different treatments.
Measured: One year approximately
Ultrasound signs of plantar warts
Compare the ultrasound signs of plantar warts with the ultrasound signs of healthy skin after the resolution of the process.
Measured: One year approximately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar WartStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Model description
- Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara García Oreja, Universidad Complutense de Madrid
- Investigators
- Francisco Javier Álvaro Afonso, PhD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654091
- Sponsor's protocol ID
- 19/471-R_X_TesisUCM
- Status last verified
- Nov 2020
- First submitted
- 22 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy With Liquid Nitrogen and Nitric-zinc Complex in the Treatment of Plantar Warts. Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT04654091
- Acronym / sponsor ID
- 19/471-R_X_TesisUCM
- Conditions
- Plantar Wart
- Keywords
- plantar wart, nitric acid, cryotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 Dec 2020 (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.
Plantar warts are benign skin lesions caused by human papillomavirus (HPV).There are several treatment methods for this illness, but none of them can heal all patients. Cryotherapy using liquid nitrogen is one of the most common local treatments. In this study, we will compare the effectiveness of cryotherapy with liquid nitrogen with the association of organic acids and nitric acid (nitric-zinc complex). In addition, as secondary objectives have been defined: 1) know the number of applications necessary for each treatment to achieve the complete resolution of the plantar wart, in order to compare the healing times between each treatment and establish which treatment is faster, 2) analyze the influence of the HPV biotype, the location of the lesion and the time of evolution in the response to the different treatments, and 3) Compare the ultrasound signs of plantar warts with the ultrasound signs of healthy skin after the resolution of the process.
Detailed description
A randomized controlled clinical trial is proposed. The recruitment of patients will be carried out by including the sample of those patients who have diagnostic confirmation of plantar wart in the Chiropodology and Surgery Service of the University Podiatry Clinic of the Complutense University of Madrid, consecutively, between November 2020 and the date when the estimated sample size is reached.
Participants in the trial will be assigned with equal probability to each treatment arm, based on their consecutive inclusion in the study. Subsequently, the treatment allocation will be determined by a random code generated by the Epidat 4.1 program using random permuted blocks. The treatment used will be evident both for the participant and for the research podiatrist responsible for the intervention. However, the primary result will be confirmed by the microbiological study carried out by the Department of Microbiology of the Complutense University of Madrid, which does not know any data about the patient or the treatment group to which it was initially assigned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Cryoteraphy with liquid nitrogen | Experimental | Procedure: Cryoteraphy with liquid nitrogenPatients older than 18 years with a diagnosis of plantar wart, who have agreed to participate in the study. |
| Nitric-zinc complex | Experimental | Procedure: Nitric-zinc complexPatients older than 18 years with a diagnosis of plantar wart, who have agreed to participate in the study. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects older than 12 years.
- Patients diagnosed with recalcitrant or non-recalcitrant plantar wart.
Key exclusion criteria (7 listed)
- Diagnosis of Diabetes Mellitus.
- Peripheral vascular disease.
- Patients with an immune system disorder or in immunosuppressants treatment.
- Peripheral or central neuropathy.
- Coagulation disorders.
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 |
|---|---|---|
| Cryoteraphy with liquid nitrogenWeekly, at each visit, before applying the treatment, a debridement of the hyperkeratotic tissue covering the wart will be performed with a scalpel handle of number 3 and a scalpel blade of number 15, and then the treatment will be applied. Subsequently, the application of cryotherapy with liquid nitrogen will be carried out using CryoPen b® (HO Equipment, Hhislenghien-Belgium). To analyze the homogeneous application in all the patients in the study, perform 2 applications of 15 seconds per session, with an interval of 30 seconds between each application, such and as manufacturers recommend. The number of sessions in which the product is applied will be a maximum of 5, following the procedure of previous studies. | Procedure or surgery | Cryoteraphy with liquid nitrogen |
| Nitric-zinc complexWeekly, at each visit, before applying the treatment, a debridement of the hyperkeratotic tissue covering the wart will be performed with a scalpel handle of number 3 and a scalpel blade of number 15, and then the treatment will be applied. Subsequently, the application of nitric acid-zinc complex with Verrutop® (Isdin, Barcelona-Spain) will be carried out. The preparation is applied by making small touches with the applicators included in the product. The number of sessions in which the product is applied will be a maximum of 5, following the recommendations of the manufacturers in the product data sheet. | Procedure or surgery | Nitric-zinc complex |
Primary outcome
Cryotherapy efficacy versus nitric-zinc complex
Time frame: One year approximately
Compare the cure rates of the following topical treatments of plantar warts: cryotherapy with liquid nitrogen; and the association of organic acids and nitric acid (nitric-zinc complex), in a period of 12 weeks. A polymerase chain reaction (PCR) test will be performed when there is an absence of clinical signs and symptoms of plantar wart, considering cure when a negative result is obtained. In those patients in whom the maximum number of treatment sessions recommended in the technical sheet of each product has been carried out and clinical signs of plantar wart are still observed, as well as in those patients who after 12 weeks of follow-up continue to present signs and symptoms Clinicians will be considered as not cured, considering the study ended.
3 secondary outcomes
Number of applications
Time frame: One year approximately
Influence of the characteristics of the lesion
Time frame: One year approximately
Ultrasound signs of plantar warts
Time frame: One year approximately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
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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.
Francisco Javier Álvaro Afonso, PhD principal investigator
Universidad Complutense de Madrid
Questions about this trial
What is this clinical trial studying?
A study testing Cryoteraphy with liquid nitrogen and Nitric-zinc complex in people with Plantar Wart, run by Universidad Complutense de Madrid.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara García Oreja, PhD Student (695057067, sagarc14@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cryotherapy efficacy versus nitric-zinc complex (time frame: One year approximately). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2020.