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

Sponsor

Combined Military Hospital Abbottabad (Other)

Overall Status

Completed

CT.gov ID

NCT05588999

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Plantar Wart	Procedure: Cryotherapy Alone Combination Product: Cryotherapy plus Salicylic Acid	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Actual Primary Completion Date :

Aug 31, 2022

Actual Study Completion Date :

Aug 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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