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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04654091
Other study ID # 19/471-R_X_TesisUCM
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2021

Study information

Verified date November 2020
Source Universidad Complutense de Madrid
Contact Sara García Oreja, PhD Student
Phone 695057067
Email sagarc14@ucm.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 18
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad Complutense de Madrid

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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