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

NCT ID: NCT05897112

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-04-30

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.

Conditions

Molluscum Contagiosum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A received cryotherapy

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 Type: ACTIVE_COMPARATOR

Group A received cryotherpay

Intervention Type: DRUG

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 solution twice daily with the help of a cotton tip applicator until lesion showed signs of inflammation or clearance for 3 weeks

Group Type: ACTIVE_COMPARATOR

Group B received 10% Potassium Hydroxide Solution

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Combined Military Hospital Abbottabad

OTHER

Sponsor Role: lead

Responsible Party

danyal sajjad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CMH Abbottabad

Abbottābād, Khyber Pakhtunkhwa, Pakistan

Countries

Pakistan

Other Identifiers

CMHAbbottabad22

Identifier Type: -

Identifier Source: org_study_id