NCT06896929

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 20, 2025

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

March 20, 2025

Last Update Submit

April 17, 2025

Conditions

Keywords

Comparison of permethrin and ivermectin in scabies

Outcome Measures

Primary Outcomes (1)

  • Cure of scabies.

    Cure will be labeled if greater han 50% reduction in no of lesions and pruritis observed after 4 weeks of treatment.

    12 months

Study Arms (3)

Group A

EXPERIMENTAL

Group A will be given Permethrin

Drug: Permethrin Cream, 5%

Group B

EXPERIMENTAL

Group B will be given Permethrin 5% cream twice application

Drug: Permethrin Cream, 5%

Group C

EXPERIMENTAL

Group C will be given Tab Ivermectin

Drug: Ivermectin 200 µg/kg

Interventions

Permethrin 5% cream will be given as a single application

Group A

Group C will be given Tab Ivermectin

Group C

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Hospital Lahore

Lahore, Punjab Province, Pakistan

Location

Related Links

MeSH Terms

Conditions

Scabies

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Mite InfestationsEctoparasitic InfestationsSkin Diseases, ParasiticParasitic DiseasesInfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR SADAF WAZIR

Study Record Dates

First Submitted

March 20, 2025

First Posted

March 26, 2025

Study Start

May 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 20, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Clinical Study Report (permethrin)Access

Locations