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Comparison of Topical 5%Potassium Hydroxide vs Liquid Nitrogen in the Treatment of Plane Warts

Primary Purpose

Plan Warts

Status

Completed

Phase

Phase 1

Locations

Pakistan

Study Type

Interventional

Intervention

5%potassium hydroxide

Liquid nitrogen

About this trial

This is an interventional treatment trial for Plan Warts

Eligibility Criteria

4 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 4-30 years Both males and females Greater than 3 number of warts Exclusion Criteria: Pregnancy Breast feeding Those who are taking immunosupressive drugs

Sites / Locations

Sana aslam

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group A Topical 5% potassium hydroxide

Group B Liquid nitrogen

Arm Description

In group-A 30 patients were given topical 5%-potassium hydroxide solution on affected area once at night upto 4 weeks

in group-B 30 patients treated with cotton bud method of cryotherapy with liquid nitrogen once every two weeks. Patients were reassessed at every two weeks and final assessment was done at 12th week.

Outcomes

Primary Outcome Measures

Comparative Efficacy of topical 5% Potassium hydroxide and liquid nitrogen in the treatment of plane warts

Decrease in number or size of warts

Secondary Outcome Measures

Full Information

NCT ID

NCT05895071

First Posted

May 16, 2023

Last Updated

May 30, 2023

Sponsor

Combined Military Hospital Abbottabad

1. Study Identification

Unique Protocol Identification Number

NCT05895071

Brief Title

Comparison of Topical 5%Potassium Hydroxide vs Liquid Nitrogen in the Treatment of Plane Warts

Official Title

Comparative Efficacy of Topical 5%Potassium Hydroxide vs Liquid Nitrogen in the Treatment of Plane Warts

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

November 1, 2022 (Actual)

Primary Completion Date

April 30, 2023 (Actual)

Study Completion Date

April 30, 2023 (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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

ABSTRACT Objective: To study the efficacy while comparing Potassium hydroxide 5% with liquid nitrogen in treatment of plane warts. Study design: Randomized-controlled trial (RCT), (Double-blind). Study setting and duration: Dept dermatology, CMH-Abbottabad, Nov-2022 / April-2023. Methodology: The sample size of 60 patients (children and adults aged 4 to 30 years) was calculated using Openepi app sample size RCT calculator, after informed consent by using non-probability consecutive sampling technique. Patients randomly assigned into two groups i.e. In group-A 30 patients were given topical 5%-potassium hydroxide solution on affected area once at night upto 4 weeks and in group-B 30 patients treated with cotton bud method of cryotherapy with liquid nitrogen once every two weeks. Patients were reassessed at every two weeks and final assessment was done at 12th week whereas followed up for 3 months to monitor recurrence. Demographic information and frequency percentages were calculated for qualitative variables by using SPSS26. To determine statistical significance taking p-value <0.05 as significant, and χ2-square test was used.

6. Conditions and Keywords

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

Plan Warts

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A Topical 5% potassium hydroxide

Arm Type

Active Comparator

Arm Description

In group-A 30 patients were given topical 5%-potassium hydroxide solution on affected area once at night upto 4 weeks

Arm Title

Group B Liquid nitrogen

Arm Type

Active Comparator

Arm Description

in group-B 30 patients treated with cotton bud method of cryotherapy with liquid nitrogen once every two weeks. Patients were reassessed at every two weeks and final assessment was done at 12th week.

Intervention Type

Drug

Intervention Name(s)

5%potassium hydroxide

Intervention Description

. In group-A 30 patients were given topical 5% potassium hydroxide solution on affected area once at night for upto 4 weeks

Intervention Type

Drug

Intervention Name(s)

Liquid nitrogen

Intervention Description

in group-B 30 patients treated with cotton bud method of cryotherapy with liquid nitrogen once every two weeks. Patients were reassessed at every two weeks. The treatment carried out upto 12 weeks or until complete recovery from warts.

Primary Outcome Measure Information:

Title

Comparative Efficacy of topical 5% Potassium hydroxide and liquid nitrogen in the treatment of plane warts

Description

Decrease in number or size of warts

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 4-30 years Both males and females Greater than 3 number of warts Exclusion Criteria: Pregnancy Breast feeding Those who are taking immunosupressive drugs

Facility Information:

Facility Name

Sana aslam

City

Abbottabad

State/Province

Khyber Pakhtun Khwaa

ZIP/Postal Code

22010

Country

Pakistan

12. IPD Sharing Statement

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Comparison of Topical 5%Potassium Hydroxide vs Liquid Nitrogen in the Treatment of Plane Warts

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