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

Sponsor

Combined Military Hospital Abbottabad (Other)

Overall Status

Completed

CT.gov ID

NCT05895071

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Plan Warts	Drug: 5%potassium hydroxide Drug: Liquid nitrogen	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2022

Actual Primary Completion Date :

Apr 30, 2023

Actual Study Completion Date :

Apr 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Comparative Efficacy of topical 5% Potassium hydroxide and liquid nitrogen in the treatment of plane warts [12 weeks]
Decrease in number or size of warts

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 30 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sana aslam	Abbottabad	Khyber Pakhtun Khwaa	Pakistan	22010

Sponsors and Collaborators

Combined Military Hospital Abbottabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr sana aslam, Principal investigator, Combined Military Hospital Abbottabad

ClinicalTrials.gov Identifier:

NCT05895071

Other Study ID Numbers:

Cmh abbottabad123

First Posted:

Jun 8, 2023

Last Update Posted:

Jun 8, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Warts

Study Results

No Results Posted as of Jun 8, 2023