Comparison of Permethrin and Ivermectin in Children Greater Than 6 Yrs Age for Treatment of Scabies (not existed)

April 17, 2025 updated by: Sadaf Wazir, Children Hospital and Institute of Child Health, Lahore

Comparison of Topical Permethrin 1 Day Verses 2 Day Application Versus Oral Ivermectin for Treatment of Scabies in Children Greater Than 6 Yrs of Age

Scabies is highly contagious,pruritic infestation of skin.Various treatment modalities have been used but search for ideal scabicide is ongoing.we wnt to coduct this study to compare the outcome of permethrin verses ivermectin in children for treatment of scabies .This randomized clinical trial will be done in children hospital lahore for 12 months.Sample size of 90 cases;30 in each group will be included through non probability consecutive sampling.Then patient will be randomly divided into 3 groups.In group A patient will be given 5% permethrin topical application to whole body single application. In Group B ,patients will be given topical permethrin for twice application 24 hrs appart ,In group C patients will be given Tablet Ivermectin single dose 200microgram/kg.Then patients will be examined after 2 weeks and 4 weeks for no of lesions and pruritis and cure will be labeled.All this information will be recorded on performa .Data will be entered and analysed by using SPSS version 26.Three groups will be compared for cure by using chi-square test.P value less than and equal to 0.05 will be considered as significant.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • children hospital Lahore
        • Contact:
          • Sadaf Wazir, MBBs

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 6-15
  • Both genders
  • Diagnosed with scabies (as per operational definition)

Exclusion Criteria:

  • Children with recurrent scabies on medical record
  • Known allergy to ivermectin or permethrin.
  • Widespread eczema or impetigo.
  • Liver dysfunction or renal failure

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
Experimental: Group A
Group A will be given Permethrin
Drug: Permethrin Cream, 5%
Permethrin 5% cream will be given as a single application
Drug: Permethrin Cream, 5%
Permethrin Cream will be given as twice application
Experimental: Group B
Group B will be given Permethrin 5% cream twice application
Drug: Permethrin Cream, 5%
Permethrin 5% cream will be given as a single application
Drug: Permethrin Cream, 5%
Permethrin Cream will be given as twice application
Experimental: Group C
Group C will be given Tab Ivermectin
Drug: Ivermectin 200 µg/kg
Group C will be given Tab Ivermectin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure of scabies.
Time Frame: 12 months
Cure will be labeled if greater han 50% reduction in no of lesions and pruritis observed after 4 weeks of treatment.
12 months

Collaborators and Investigators

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

Sponsor

Children Hospital and Institute of Child Health, Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Estimated)

May 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 715-24-10-2023ApprovedbyCHUCHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Clinical Study Report
    Information identifier: permethrin
    Information comments: Comparison of permethrin and ivermectin in scabies was done

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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