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

November 22, 2022 updated by: Huma Farid, Combined Military Hospital Abbottabad

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KPK
      • Abbottabad, KPK, Pakistan, 22010
        • CMH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria <100 lesions no therapy within the earlier one month

Exclusion Criteria:

known hypersensitivity and immunodeficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
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
Drug: potassium hydroxide
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.
Active Comparator: group B
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
Drug: potassium hydroxide
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
. 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
06 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Combined Military Hospital Abbottabad

Investigators

  • Principal Investigator: Bushra Muzaffar, FCPS, CMH Abbottabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

November 22, 2022

First Submitted That Met QC Criteria

November 22, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Actual)

December 2, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMHAtd-ETH-04-Derm-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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