Clinical trial

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

Name
CMHAbbottabad22
Description
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.
Trial arms
Trial start
2022-11-01
Estimated PCD
2023-04-30
Trial end
2023-04-30
Status
Completed
Phase
Early phase I
Treatment
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
Arms:
Group A received cryotherapy
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
Arms:
Group B received 10% Potassium Hydroxide Solution
Size
60
Primary endpoint
Efficacy was assessed at 12th week by the clearance of lesion or not
12 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-06-09

1 organization

2 products

1 indication

Product
Group A