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Comparison of 5% Potassium Hydroxide With 10% Potassium Hydroxide Solution in Treatment of Molluscum Contagiosum

Primary Purpose

Molluscum Contagiosum

Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
potassium hydroxide
Sponsored by
Combined Military Hospital Abbottabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molluscum Contagiosum focused on measuring potassium hydroxide 5% and 10% lotion

Eligibility Criteria

2 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria <100 lesions no therapy within the earlier one month Exclusion Criteria: known hypersensitivity and immunodeficiency

Sites / Locations

  • CMH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

group B

Arm Description

patients in group A treated with 5% potassium hydroxide on every lesion once daily via cotton-tipped applicator for at least two weeks or till inflammatory manifestations

patients in group B treated with10% potassium hydroxide on every lesion once daily via cotton-tipped applicator for at least two weeks or till inflammatory manifestations

Outcomes

Primary Outcome Measures

. Efficacy was classified as follows: • complete remission (≥ 90% clearance of lesions) • partial remission (60-90% clearance of lesions) • insignificant improvement (<60% clearance of lesions)

Secondary Outcome Measures

Full Information

First Posted
November 22, 2022
Last Updated
November 22, 2022
Sponsor
Combined Military Hospital Abbottabad
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1. Study Identification

Unique Protocol Identification Number
NCT05634460
Brief Title
Comparison of 5% Potassium Hydroxide With 10% Potassium Hydroxide Solution in Treatment of Molluscum Contagiosum
Official Title
Comparison of 5% Potassium Hydroxide With 10% Potassium Hydroxide Solution in Treatment of Molluscum Contagiosum
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (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
Molluscum is a virus-related skin infestation which is commonly seen among children. Molluscipox virus, the largest human virus, causes it. MC typically manifests as a single or multiple dome-shaped, shiny, pearly white papules with a central dimple. In immunocompetent individuals, spontaneous resolution usually occurs within 18 months; however, the lesion may persist for several years. Asymptomatic lesions are common. It is also linked to a high risk of transmission and an increasing prevalence in global populations1-2. Patients may receive therapy for social and cosmetic reasons, and also to avoid spreading disease to others. Numerous modalities are currently available, including Potassium hydroxide, curettage, cryotherapy, disinfected needle pricking, photodynamic therapy, laser, salicylic acid, glycolic acid etc3-4. Potassium hydroxide (KOH) is a topical treatment for Molluscum contagiosum. Dermatologists routinely use potassium hydroxide (KOH) in varying concentrations to identify fungal elements. Because it is a strong alkali with keratolytic characteristics, variable concentrations given for management of MC. Because it is inexpensive and widely accessible, it has the potential to be a useful method for treating for MC in resource-constrained countries5-6. The purpose of this study is to examine two varied concentrations of Potassium hydroxide (5%-KOH vs 10%-KOH) among MC patients in order to determine the most effective KOH concentration to manage Molluscum Contagiosum among children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molluscum Contagiosum
Keywords
potassium hydroxide 5% and 10% lotion

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
Arm Type
Active Comparator
Arm Description
patients in group A treated with 5% potassium hydroxide on every lesion once daily via cotton-tipped applicator for at least two weeks or till inflammatory manifestations
Arm Title
group B
Arm Type
Active Comparator
Arm Description
patients in group B treated with10% potassium hydroxide on every lesion once daily via cotton-tipped applicator for at least two weeks or till inflammatory manifestations
Intervention Type
Drug
Intervention Name(s)
potassium hydroxide
Intervention Description
Potassium hydroxide (KOH) is a topical treatment for Molluscum contagiosum. Dermatologists routinely use potassium hydroxide (KOH) in varying concentrations to identify fungal elements. Because it is a strong alkali with keratolytic characteristics, variable concentrations given for management of MC.
Primary Outcome Measure Information:
Title
. Efficacy was classified as follows: • complete remission (≥ 90% clearance of lesions) • partial remission (60-90% clearance of lesions) • insignificant improvement (<60% clearance of lesions)
Time Frame
06 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria <100 lesions no therapy within the earlier one month Exclusion Criteria: known hypersensitivity and immunodeficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bushra Muzaffar, FCPS
Organizational Affiliation
Combined Military Hospital Abbottabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMH
City
Abbottabad
State/Province
KPK
ZIP/Postal Code
22010
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

Comparison of 5% Potassium Hydroxide With 10% Potassium Hydroxide Solution in Treatment of Molluscum Contagiosum

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