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

Study Overview
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Brief Summary
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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.

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

Conditions
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Molluscum Contagiosum

Intervention / Treatment
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* Drug: Group A received cryotherpay
* Drug: Group B received 10% Potassium Hydroxide Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A received cryotherapy<br>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<br>* 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<br>|
| Active Comparator: Group B received 10% Potassium Hydroxide Solution<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |