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Not yet recruiting NCT07247630

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

Early Phase I Interventional Scabies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Permethrin 5%.
Who it may be relevant to
Registry conditions: Scabies. Basic parameters: 1 months — 4 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Drug Permethrin 5%
    permethrin application

Primary outcome measures

  • Treatment of scabies [Time frame: 15 days]
Secondary outcome measures (2)
  • Scabies [Time frame: 15 days]
  • Scabies [Time frame: 15 days]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Pak emirates military hospital,Rawalpindi — Rawalpindi

Identifiers

NCT: NCT07247630 · A/28/ERC.63.25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗