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

May 30, 2023 updated by: Dr sana aslam, Combined Military Hospital Abbottabad

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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 Pakhtun Khwaa
      • Abbottabad, Khyber Pakhtun Khwaa, Pakistan, 22010
        • Sana aslam

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

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 Topical 5% potassium hydroxide
In group-A 30 patients were given topical 5%-potassium hydroxide solution on affected area once at night upto 4 weeks
Drug: 5%potassium hydroxide
. In group-A 30 patients were given topical 5% potassium hydroxide solution on affected area once at night for upto 4 weeks
Active Comparator: Group B Liquid nitrogen
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.
Drug: Liquid nitrogen
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative Efficacy of topical 5% Potassium hydroxide and liquid nitrogen in the treatment of plane warts
Time Frame: 12 weeks
Decrease in number or size of warts
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)

November 1, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cmh abbottabad123

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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