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

Molluscum Contagiosum Clinical Trial

Official title:

Comparison of 10% Potassium Hydroxide Solution Versus Cryotherapy in the Treatment of Molluscum Contagiosum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05897112
• Other study ID #: CMHAbbottabad22
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: Combined Military Hospital Abbottabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Molluscum Contagiosum

Intervention

Drug:
• 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 applied 10% potassium hydroxide aqueous solution twice daily with the help of a cotton tip applicator until lesion showed signs of inflammation or clearance for 3 weeks

Locations

Country	Name	City	State
Pakistan	CMH Abbottabad	Abbottabad	Khyber Pakhtunkhwa

Sponsors (1)

Lead Sponsor	Collaborator
Combined Military Hospital Abbottabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy was assessed at 12th week by the clearance of lesion or not	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).	12 weeks