Back to resultsComparative Efficacy of 10% Potassium Hydroxide Solution Versus Cryotherapy in Molluscum Contagiosum
Primary Purpose
Molluscum Contagiosum
Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Group A received cryotherpay
Group B received 10% Potassium Hydroxide Solution
Sponsored by
About this trial
This is an interventional treatment trial for Molluscum Contagiosum
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
Sites / Locations
- CMH Abbottabad
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A received cryotherapy
Group B received 10% Potassium Hydroxide Solution
Arm Description
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 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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT05897112
First Posted
May 19, 2023
Last Updated
May 31, 2023
Sponsor
Combined Military Hospital Abbottabad
1. Study Identification
Unique Protocol Identification Number
NCT05897112
Brief Title
Comparative Efficacy of 10% Potassium Hydroxide Solution Versus Cryotherapy in Molluscum Contagiosum
Official Title
Comparison of 10% Potassium Hydroxide Solution Versus Cryotherapy in the Treatment of Molluscum Contagiosum
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Abbottabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molluscum Contagiosum
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A received cryotherapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group B received 10% Potassium Hydroxide Solution
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Group A received cryotherpay
Intervention Description
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
Intervention Name(s)
Group B received 10% Potassium Hydroxide Solution
Intervention Description
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
Primary Outcome Measure Information:
Title
Efficacy was assessed at 12th week by the clearance of lesion or not
Description
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).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CMH Abbottabad
City
Abbottābād
State/Province
Khyber Pakhtunkhwa
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Comparative Efficacy of 10% Potassium Hydroxide Solution Versus Cryotherapy in Molluscum Contagiosum
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