Plantar Wart Clinical Trial
Official title:
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universidad Complutense de Madrid |
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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