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

Primary Purpose

Plantar Wart

Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Cryotherapy Alone
Cryotherapy plus Salicylic Acid
Sponsored by
Combined Military Hospital Abbottabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Wart focused on measuring Planter Warts, Cryotherapy, Salicylic Acid

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Cmh Abbottabad

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A (Cryotherapy Alone)

Group B (Cryotherapy plus Salicylic Acid)

Arm Description

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

Patients in this Group were subjected to cryotherapy plus salicylic acid for a maximum of eight weeks

Outcomes

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
effectiveness assesed by %clinical improvement=(present % tissue distruction + baseline % tissue destruction)100

Secondary Outcome Measures

Full Information

First Posted
October 11, 2022
Last Updated
October 17, 2022
Sponsor
Combined Military Hospital Abbottabad
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1. Study Identification

Unique Protocol Identification Number
NCT05588999
Brief Title
Comparative Study Between Treatment With Cryotherapy Alone Versus Cryotherapy Plus Salicylic Acid Dressing for Planter Warts
Official Title
Comparative Study Between Treatment With Cryotherapy Alone Versus Cryotherapy Plus Salicylic Acid Dressing for Planter Warts
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Abbottabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Wart
Keywords
Planter Warts, Cryotherapy, Salicylic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (Cryotherapy Alone)
Arm Type
Active Comparator
Arm Description
Patients in this Group were subjected to Cryotherapy Alone with liquid nitrogen and received maximum of four treatments given two to three weeks apart
Arm Title
Group B (Cryotherapy plus Salicylic Acid)
Arm Type
Active Comparator
Arm Description
Patients in this Group were subjected to cryotherapy plus salicylic acid for a maximum of eight weeks
Intervention Type
Procedure
Intervention Name(s)
Cryotherapy Alone
Intervention Description
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
Intervention Type
Combination Product
Intervention Name(s)
Cryotherapy plus Salicylic Acid
Intervention Description
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
Primary Outcome Measure Information:
Title
effectiveness of cryotherapy with liquid nitrogen alone and cryotherapy with 50% salicylic acid for the treatment of plantar warts calculated through clinical improvement
Description
effectiveness assesed by %clinical improvement=(present % tissue distruction + baseline % tissue destruction)100
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cmh Abbottabad
City
Abbottābād
State/Province
Khyber Pakhtunkhwa
ZIP/Postal Code
22020
Country
Pakistan

12. IPD Sharing Statement

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

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