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

NCT05895071 | Completed Phase 1

• 1 other identifier: Cmh abbottabad123
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Plan Warts

Outcome Measures

Primary Outcomes (1)

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

  Decrease in number or size of warts

  12 weeks

Study Arms (2)

Group A Topical 5% potassium hydroxide

ACTIVE COMPARATOR

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

Group B Liquid nitrogen

ACTIVE COMPARATOR

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

Interventions

5%potassium hydroxide DRUG

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

Group A Topical 5% potassium hydroxide

Liquid nitrogen DRUG

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.

Group B Liquid nitrogen

Eligibility Criteria

• Age: 4 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 4-30 years
• Both males and females
• Greater than 3 number of warts

You may not qualify if:

• Pregnancy
• Breast feeding
• Those who are taking immunosupressive drugs

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (1)

Sana aslam

Abbottabad, Khyber Pakhtun Khwaa, 22010, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 8, 2023
• Study Start: November 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-05

Locations

PA (1)