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

NCT04654091 | Unknown DMC

• 1 other identifier: 19/471-R_X_TesisUCM
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Plantar Wart

Keywords

plantar wart; nitric acid; cryotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of applications

  One year approximately

• Influence of the characteristics of the lesion

  One year approximately

• Ultrasound signs of plantar warts

  One year approximately

Study Arms (2)

Cryoteraphy with liquid nitrogen

EXPERIMENTAL

Patients older than 18 years with a diagnosis of plantar wart, who have agreed to participate in the study.

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.

Procedure: Nitric-zinc complex

Interventions

Cryoteraphy with liquid nitrogen PROCEDURE

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.

Cryoteraphy with liquid nitrogen

Nitric-zinc complex PROCEDURE

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.

Nitric-zinc complex

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects older than 12 years.
• Patients diagnosed with recalcitrant or non-recalcitrant plantar wart.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Officials

• Francisco Javier Álvaro Afonso, PhD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara García Oreja, PhD Student

CONTACT

695057067; sagarc14@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: December 4, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 4, 2020

Record last verified: 2020-11