Comparative Efficacy of 10% Potassium Hydroxide Solution Versus Cryotherapy in Molluscum Contagiosum

Phase 1

Completed

• Conditions: Molluscum Contagiosum
• Interventions: Drug: Group A received cryotherpay; Drug: Group B received 10% Potassium Hydroxide Solution

• Registration Number: NCT05897112
• Lead Sponsor: Combined Military Hospital Abbottabad

Brief Summary

A total of sixty patients presented to the outpatient dermatology department of Combined military hospital (CMH) Abbottabad with signs of molluscum contagiosum clinically diagnosed meeting inclusion criteria were enrolled. Sample size was calculated using WHO sample size calculator. They were divided into two groups i.e Group A and Group B using lottery method. Patients in Group A were subjected to cryotherapy (liquid nitrogen gas) whereas patients in Group B patients were subjected to 10% potassium hydroxide solution for 3 weeks and were followed up at 2nd, 4th, 8th and 12th week for observing the progress of therapy in both groups on each follow up visit and ascertaining the efficacy respectively.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2023-05
• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-31
• Last Update Submitted: 2023-05-31
• Study First Posted: 2023-06-09
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• clinical diagnosis of molluscum contagiosum having 3-20 lesion
• no history of treatment before
• willingness to participate (given by parents)

Exclusion Criteria

• Patients with facial lesions
• known immunodeficiency
• tendency for hypertrophic scarring
• known hypersensitivity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A received cryotherapy	Group A received cryotherpay	Group A were subjected to weekly cryotherapy with a cotton stick dip ped in Liquid Nitrogen for 02 Freezes and Thaw Cycle of 07 seconds with each cycle 10 seconds apart for 3 weeks
Group B received 10% Potassium Hydroxide Solution	Group B received 10% Potassium Hydroxide Solution	Group B applied 10% Potassium Hydroxide solution twice daily with the help of a cotton tip applicator until lesion showed signs of inflammation or clearance for 3 weeks

Primary Outcome Measures

Name	Time	Method
Efficacy was assessed at 12th week by the clearance of lesion or not	12 weeks	Final evaluation in terms of efficacy was done at the follow up visit in 12th week and the method was termed as effective (Yes) on achieving complete clearance of lesions confirmed on clinical \& physical examination of the affected areas by a consultant dermatologist using dermoscopy showing complete resolution of lesions. However, if lesions were not completely cleared at the end of 12th week, the treatment method was labelled as ineffective (No).

Trial Locations

Locations (1)

CMH Abbottabad; 🇵🇰 Abbottābād, Khyber Pakhtunkhwa, Pakistan