Cryotherapy VS. Nitric-zinc Complex in the Treatment of Plantar Warts.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04654091 |
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Recruitment Status :
Not yet recruiting
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Plantar Wart | Procedure: Cryoteraphy with liquid nitrogen Procedure: Nitric-zinc complex | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 18 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Randomised Controlled Trial |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Cryotherapy With Liquid Nitrogen and Nitric-zinc Complex in the Treatment of Plantar Warts. Randomised Controlled Trial. |
| Estimated Study Start Date : | January 1, 2021 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cryoteraphy with liquid nitrogen
Patients older than 18 years with a diagnosis of plantar wart, who have agreed to participate in the study.
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Procedure: Cryoteraphy with liquid nitrogen
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. |
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Experimental: Nitric-zinc complex
Patients older than 18 years with a diagnosis of plantar wart, who have agreed to participate in the study.
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Procedure: Nitric-zinc complex
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. |
- 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.
- Number of applications [ Time Frame: One year approximately ]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.
- Influence of the characteristics of the lesion [ Time Frame: One year approximately ]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.
- Ultrasound signs of plantar warts [ Time Frame: One year approximately ]Compare the ultrasound signs of plantar warts with the ultrasound signs of healthy skin after the resolution of the process.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects older than 12 years.
- Patients diagnosed with recalcitrant or non-recalcitrant plantar wart.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04654091
| Contact: Sara García Oreja, PhD Student | 695057067 | sagarc14@ucm.es |
| Principal Investigator: | Francisco Javier Álvaro Afonso, PhD | Universidad Complutense de Madrid |
| Responsible Party: | Sara García Oreja, Principal Investigator, Universidad Complutense de Madrid |
| ClinicalTrials.gov Identifier: | NCT04654091 |
| Other Study ID Numbers: |
19/471-R_X_TesisUCM |
| First Posted: | December 4, 2020 Key Record Dates |
| Last Update Posted: | December 4, 2020 |
| Last Verified: | November 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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plantar wart nitric acid cryotherapy |
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Warts Foot Diseases Papillomavirus Infections DNA Virus Infections Virus Diseases |
Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases Musculoskeletal Diseases |