Comparison of Permethrin-Based Treatment Strategies Against Scabies in Infants and Young Children

To compare the efficacy of different permethrin-based therapies for scabies infestations in infants and young children.

Study Overview

• Status: Not yet recruiting
• Conditions: Scabies
• Intervention / Treatment: Drug: Permethrin 5%

Detailed Description

Globally, Scabies infects 300 million people each year and among children of developing countries, its prevalence is estimated to be about 5-10%.In Pakistan, Scabies accounts for 38% of dermatological diseases. Males are more prone to infestation than females, and early school- aged children are the most vulnerable as it is usually transmitted by prolonged skin-skin contact.

It was more widespread in urban than in rural areas with a distinct seasonal pattern, with the biggest infestation occurring in the winter and the lowest in the summer with all risk factors accounting for 89% of the variation in its prevalence.The classic scabies symptoms include an erythematous papular eruption, burrows, and intense itching with a predilection for fingers, axilla, elbows, waist, belly, groin, genital area, etc. Several antiscabietic treatment options exist, including topically applied permethrin, benzyl benzoate (BB) and crotamiton, and oral ivermectin.5 Repeated administration of topical permethrin 5%, topical BB 10-25% or systemic ivermectin dosed at 200 μg/kg body weight is currently recommended as first-line treatment by the 2017 European guidelines for the management of scabies.Permethrin, a synthetic pyrethroid with scabicidal and ovicidal activity, disrupts the function of the voltage-gated sodium channels in the neuronal membrane of the mites, resulting in paralysis and death. Permethrin is highly effective against scabies and well- tolerated without major side-effects, as it is minimally absorbed through the skin and rapidly eliminated, thus exerting minimal systemic presence in humans.Hence, it is recommended as a first-line therapy for adults and children in many countries

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Shanza zafar, MBBs; Phone Number: +923425316096; Email: shanza444@gmail.com

Study Locations

• Pakistan
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan, 00666
      • Pak emirates military hospital,Rawalpindi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1 month to 4 years age.
• Both gender
• Scabies as defined in operational definition

Exclusion Criteria:

• • Drug sensitivity test results for hypersensitivity to permethrin

  • Having renal or hepatic impairment.
  • Individuals with additional long-term skin and systemic disorders (such as diabetes, hypertension, asthma, epilepsy, acne, psoriasis)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard permethrin treatment	Drug: Permethrin 5%; permethrin application
Active Comparator: Intensified permethrin treatment	Drug: Permethrin 5%; permethrin application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment of scabies	For efficacy, we will see microscopy (presence of any one by examine skin scraping under a microscope for mites(eyeless and spherical in shape with eight legs parasite)/eggs (oval shape).The absence of these will be considered significant.	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scabies	Absence of burrows on skin	15 days
Scabies	Absence of pruritus	15 days

Collaborators and Investigators

• Sponsor: College of Physicians and Surgeons Pakistan

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): March 15, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: November 22, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Permethrin based treatment strategies
• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Skin Diseases; Skin Diseases, Infectious; Skin Diseases, Parasitic; Mite Infestations; Ectoparasitic Infestations; Skin and Connective Tissue Diseases; Scabies
• Other Study ID Numbers: A/28/ERC.63.25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No