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

College of Physicians and Surgeons Pakistan

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Scabies

Treatments: Drug: Permethrin 5%

Study type: Interventional

Funder types: Other

Identifiers

NCT07247630

A/28/ERC.63.25

Details and patient eligibility

About

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

Full 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

Enrollment: 68 estimated patients

Sex: All

Ages: 1 month to 4 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Standard permethrin treatment

Active Comparator group

Description:

Standard permethrin treatment

Treatment:

Drug: Permethrin 5%

Intensified permethrin treatment

Active Comparator group

Description:

Intensified permethrin treatment

Treatment:

Drug: Permethrin 5%