Comparative Study Between Treatment With Cryotherapy Alone Versus Cryotherapy Plus Salicylic Acid Dressing for Planter Warts

October 17, 2022 updated by: Dr Mahboob Ali, Combined Military Hospital Abbottabad

Verrucae plantaris (plantar warts) are a frequent cutaneous lesion of the plantar portion of the foot caused by the human papillomavirus (HPV) (HPV).Although HPV is ubiquitous in our environment, cellular and humoral immune responses typically prevent it from spreading or eliminate it.

Warts can be painful and can lead to other difficulties, but there are some populations that are at a higher risk of getting HPV because they encounter the virus more frequently.

In addition to infecting other people, HPV can also spread to other locations in the area. While reducing exposure to risk factors can help prevent plantar wart infection, HPV's widespread nature makes it difficult for such efforts to be effective.

It has been shown in research that plantar warts can spread from person to person through just physical contact with the sores. Warts are more common in people with HPV because the virus disrupts the epithelial barrier. There are over a hundred different forms of the HPV virus, so even though some warts go away on their own after a few years, others may need medical attention.

Warts, according to a number of studies, are extremely common (affecting around 10% of the population) all over the world. More cases of HPV infection have been observed among people under the age of 30, compared to those beyond the age of 30. The estimated prevalence in the United States is between 10% and 20%. However, people with compromised immune systems and those who work with meat are disproportionately at risk.

The cancerous transformation of warts is quite rare. Even while verrucous carcinoma, a malignant form of wart development, is possible, it seldom spreads and only causes localised tissue loss.

Plantar warts are treated in a manner that takes into account the patient's symptoms, personal preferences, and financial situation. Even though there are several therapy options, none of them are particularly effective, and relapses are common after any treatment. As a result, the most accessible and least distressing treatment option should be prioritised.

Since salicylic acid can be used by the patient at home and does not require a doctor's prescription, it is often regarded a first-line therapy for the common wart. It can be as high as 70% effective in curing the disease. Other effective therapies for plantar warts include cryotherapy, retinoic acid, podophyllin, topical 5-fluorouracil, interferon, and imiquimod.

Salicylic acid, in conjunction with cryotherapy, has shown therapeutic efficacy in patients with only foot warts, according to a single prior study. Patients who were given cryotherapy in this trial had a 58% success rate at recovery, whereas those given salicylic acid had a 41% success rate. Hover, there is no discernible statistical difference.

The purpose of this study was to compare the effectiveness of cryotherapy alone against cryotherapy plus salicylic acid dressing for planter warts, keeping in mind the prevalence of treatment for plantar warts and the lack of a well-established, practically applicable, and reliably preventative method in our local population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Abbottābād, Khyber Pakhtunkhwa, Pakistan, 22020
        • CMH Abbottabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 38 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients having aged between 15 to 40 years
  • Patients diagnosed with planter warts on toe foot based on clinical and physical examination ,Patients with no history of treatment previously
  • Patients of either gender

Exclusion Criteria:

  • Patients with impaired healing (such as from diabetes or peripheral vascular disease)
  • Immunosuppressed patients
  • Patients taking immunosuppressant drugs (such as oral corticosteroids)
  • Patients with neuropathy
  • Patients receiving renal dialysis
  • Patients unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (Cryotherapy Alone)
Patients in this Group were subjected to Cryotherapy Alone with liquid nitrogen and received maximum of four treatments given two to three weeks apart
Procedure: Cryotherapy Alone

Patients in Group A were subjected to Cryotherapy Alone with liquid nitrogen and received maximum of four treatments given two to three weeks apart .

The liquid nitrogen was applied with a spray or a probe
Active Comparator: Group B (Cryotherapy plus Salicylic Acid)
Patients in this Group were subjected to cryotherapy plus salicylic acid for a maximum of eight weeks
Combination product: Cryotherapy plus Salicylic Acid
Patients in Group B were subjected to cryotherapy plus with 50% salicylic acid to be properly applied for a maximum of eight weeks The liquid nitrogen was applied with a spray or a probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effectiveness of cryotherapy with liquid nitrogen alone and cryotherapy with 50% salicylic acid for the treatment of plantar warts calculated through clinical improvement
Time Frame: 12 weeks
effectiveness assesed by %clinical improvement=(present % tissue distruction + baseline % tissue destruction)100
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Combined Military Hospital Abbottabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Actual)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMHAtd-ETH-38-Derm-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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