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Cryotherapy VS. Nitric-zinc Complex in the Treatment of Plantar Warts.

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ClinicalTrials.gov Identifier: NCT04654091
Recruitment Status : Not yet recruiting
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Sara García Oreja, Universidad Complutense de Madrid

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Plantar Wart Procedure: Cryoteraphy with liquid nitrogen Procedure: Nitric-zinc complex Not Applicable

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arm Intervention/treatment
Experimental: Cryoteraphy with liquid nitrogen
Patients older than 18 years with a diagnosis of plantar wart, who have agreed to participate in the study.
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.


Experimental: Nitric-zinc complex
Patients older than 18 years with a diagnosis of plantar wart, who have agreed to participate in the study.
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.





Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Sara García Oreja, PhD Student 695057067 sagarc14@ucm.es

Sponsors and Collaborators
Universidad Complutense de Madrid
Investigators
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Principal Investigator: Francisco Javier Álvaro Afonso, PhD Universidad Complutense de Madrid
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sara García Oreja, Universidad Complutense de Madrid:
plantar wart
nitric acid
cryotherapy
Additional relevant MeSH terms:
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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