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

NCT05897112 | Completed Phase 1

• 1 other identifier: CMHAbbottabad22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group A received cryotherapy

ACTIVE COMPARATOR

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

Drug: Group A received cryotherpay

Group B received 10% Potassium Hydroxide Solution

ACTIVE COMPARATOR

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

Drug: Group B received 10% Potassium Hydroxide Solution

Interventions

Group A received cryotherpay 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 A received cryotherapy

Group B received 10% Potassium Hydroxide Solution 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

Group B received 10% Potassium Hydroxide Solution

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (1)

CMH Abbottabad

Abbottābād, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Conditions

Molluscum Contagiosum

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

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 19, 2023
• First Posted: June 9, 2023
• Study Start: November 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-05

Locations

PA (1)