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

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.

Study Overview

• Status: Unknown
• Conditions: Plantar Wart
• Intervention / Treatment: Procedure: Cryoteraphy with liquid nitrogen; Procedure: Nitric-zinc complex

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 Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara García Oreja, PhD Student; Phone Number: 695057067; Email: sagarc14@ucm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One year approximately

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	One year approximately

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Principal Investigator: Francisco Javier Álvaro Afonso, PhD, Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: November 22, 2020
• First Submitted That Met QC Criteria: November 28, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: November 28, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: cryotherapy; plantar wart; nitric acid
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Musculoskeletal Diseases; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts; Foot Diseases
• Other Study ID Numbers: 19/471-R_X_TesisUCM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No