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Comparison of Cryotherapy and Peeling Agent in the Treatment of Common Warts

Primary Purpose

Warts

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
CRYOTHERAPY
Tricholoracetic acid
Sponsored by
Combined Military Hospital Abbottabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Warts

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patient presented with common warts in dermatology opd Exclusion Criteria: • Patients with warts on toes and tip of fingers genital warts cardiac, hepatic and renal disease hypercholesterolemia hypersensitivity reactions

Sites / Locations

  • Cmh abbottabad

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A cryotherapy

Group B Topical TCA 90%

Arm Description

Cryotherapy Group A had their warts treated once every two weeks for a total of twelve weeks, with liquid nitrogen using cryoget method for 10 to 15 seconds on each lesion (depending on size, until a narrow white rim of around 1 mm developed around it).

Topical TCA 90 % Warts in Group B were treated with liquid TCA 90% by an applicator every two weeks for a total of twelve weeks. After 20 minutes, patients were instructed to remove the solution by washing their warts with water or regular saline

Outcomes

Primary Outcome Measures

Comparison of cryotherapy and Tricholoracetic acid 90% in treatment of common warts
Outcome was determined at the end of third month and the patients were labelled as cured and the efficacy was labelled as "Yes" in cases with absence of all the lesions. After twelve weeks of therapy, individuals with persistent warts were regarded as cases of treatment failure and efficacy was labelled as "No".

Secondary Outcome Measures

Full Information

First Posted
January 18, 2023
Last Updated
January 26, 2023
Sponsor
Combined Military Hospital Abbottabad
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1. Study Identification

Unique Protocol Identification Number
NCT05712811
Brief Title
Comparison of Cryotherapy and Peeling Agent in the Treatment of Common Warts
Official Title
Cryotherapy Versus Topical Tricholoacetic Acid 90% in Treatment of Common Warts
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 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
Objective: To compare the efficacy of cryotherapy using liquid nitrogen (cryoget method) versus trichloroacetic acid 90% (applicator method) in treatment of common warts. Study Design: Randomized Control Trial. Place And Duration of Study: Department of Dermatology, CMH Abbottabad from Jun 2022 to Nov, 2022.
Detailed Description
A total of 60 patients were enrolled in this investigation by non-probability consecutive sampling technique. Sample size was calculated using WHO sample size calculator and patients were randomized into two equal groups, A and B, each comprising of 30 patients through lottery method. Patients with common warts such as hard lesions, raised lumps with rough surfaces at the back of their fingers, around nails and palm of their hands between the ages of 18 and 60 were included, whereas those with genital warts, cardiac, hepatic, renal, or hypercholesterolemia were excluded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A cryotherapy
Arm Type
Active Comparator
Arm Description
Cryotherapy Group A had their warts treated once every two weeks for a total of twelve weeks, with liquid nitrogen using cryoget method for 10 to 15 seconds on each lesion (depending on size, until a narrow white rim of around 1 mm developed around it).
Arm Title
Group B Topical TCA 90%
Arm Type
Active Comparator
Arm Description
Topical TCA 90 % Warts in Group B were treated with liquid TCA 90% by an applicator every two weeks for a total of twelve weeks. After 20 minutes, patients were instructed to remove the solution by washing their warts with water or regular saline
Intervention Type
Drug
Intervention Name(s)
CRYOTHERAPY
Other Intervention Name(s)
Liquid nitrogen
Intervention Description
Group A had their warts treated once every two weeks for a total of twelve weeks, with liquid nitrogen using cryoget method for 10 to 15 seconds on each lesion (depending on size, until a narrow white rim of around 1 mm developed around it).
Intervention Type
Drug
Intervention Name(s)
Tricholoracetic acid
Other Intervention Name(s)
Peeling agent
Intervention Description
Group B were treated with liquid TCA 90% by an applicator every two weeks for a total of twelve weeks. After 20 minutes, patients were instructed to remove the solution by washing their warts with water or regular saline.
Primary Outcome Measure Information:
Title
Comparison of cryotherapy and Tricholoracetic acid 90% in treatment of common warts
Description
Outcome was determined at the end of third month and the patients were labelled as cured and the efficacy was labelled as "Yes" in cases with absence of all the lesions. After twelve weeks of therapy, individuals with persistent warts were regarded as cases of treatment failure and efficacy was labelled as "No".
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient presented with common warts in dermatology opd Exclusion Criteria: • Patients with warts on toes and tip of fingers genital warts cardiac, hepatic and renal disease hypercholesterolemia hypersensitivity reactions
Facility Information:
Facility Name
Cmh abbottabad
City
Abbottābād
State/Province
Kpk
ZIP/Postal Code
22010
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

Comparison of Cryotherapy and Peeling Agent in the Treatment of Common Warts

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