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

NCT ID: NCT07247630

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2026-06-15

Brief Summary

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

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

Conditions

Scabies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard permethrin treatment

Standard permethrin treatment

Group Type: ACTIVE_COMPARATOR

Permethrin 5%

Intervention Type: DRUG

permethrin application

Intensified permethrin treatment

Intensified permethrin treatment

Group Type: ACTIVE_COMPARATOR

Permethrin 5%

Intervention Type: DRUG

permethrin application

Interventions

Permethrin 5%

permethrin application

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

College of Physicians and Surgeons Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Shanza zafar

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pak emirates military hospital,Rawalpindi

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Shanza zafar, MBBs

Role: CONTACT

shanza444@gmail.com

+923425316096

Other Identifiers

A/28/ERC.63.25

Identifier Type: -

Identifier Source: org_study_id