Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis

NCT ID: NCT05643820

Last Updated: 2022-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-08-31

Brief Summary

In children, pediculosis is a common ectoparasitic infestation. Infestation of head lice (Pediculus humanus capitis) causes a variety of physical symptoms, including pruritus, excoriation, cervical lymphadenopathy, and conjunctivitis1. It also has a number of negative social consequences, including parental anxiety and stigmatization of infested children2.

It is a significant public health issue that primarily affects school-aged children aged 8 to 113. In developing nations, prevalence rates of up to 40% have been reported4. The four urban areas of KPK (NWFP) reported prevalence of 36.7%5. People with a low socioeconomic background and poor hygiene are more likely to be affected6.

Pediculosis capitis has been treated using a variety of treatment modalities. They include both physician prescription and over-the-counter medications. Permethrin or ivermectin had been used topically or orally. Permethrin is a neurotoxin that is synthesized. It is a pyrethroid neurotoxic that targets voltage-sensitive Sodium ion receptors in the neurological system of the insect, triggering nerve depolarization, hyperexcitation, muscular paralysis, and, eventually, parasite death7. Ivermectin is antiparasitic medication, it is possible to treat diseases like lymphatic filariasis, and ectoparasite infestations, primarily scabies, with ivermectin because it binds to glutamate gated chloride ion receptors of invertebrates and disrupts neurotransmission8.

The rationale of this study is to study while comparing effectiveness of oral ivermectin and topical permethrin in management of pediculosis. The topical medication usage is problematic and had reported drug resistance9. There has been less regional or national research on the effectiveness of oral Ivermectin, so doctors less frequently use it in our department. Instead, the patients are treated for pediculosis capitis with topical Permethrin.

Conditions

Pediculosis

Keywords

ivermectin; permethrin 5% lotion

Study Design

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

Study Groups

Group A

Patients prescribed with topical 5% Permethrin lotion two applications seven days apart and applied overnight.

Group Type: ACTIVE_COMPARATOR

Permethrin 5% topical lotion

Intervention Type: DRUG

patients in group A prescribed with 5% topical permethrin lotion two overnight applications seven days apart

group B

Patients weighing greater than 15kgs prescribed with oral ivermectin 200microgram/kg two doses seven days apart

Group Type: ACTIVE_COMPARATOR

Ivermectin

Intervention Type: DRUG

patients in group B and weighing more than 15 kgs were given oral ivermectin 200 microgram/kg two doses seven days apart

Interventions

Permethrin 5% topical lotion

patients in group A prescribed with 5% topical permethrin lotion two overnight applications seven days apart

Intervention Type: DRUG

Ivermectin

patients in group B and weighing more than 15 kgs were given oral ivermectin 200 microgram/kg two doses seven days apart

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

both genders with live detected on clinical examination and by combing wet hair with a fine toothed lice detection comb ages 8-36 years weight >15 kgs

Exclusion Criteria

pregnancy breast feeding using any pediculicidal medication within the preceding two weeks of treatment hairstyle that may be difficult to comb

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Combined Military Hospital Abbottabad

OTHER

Sponsor Role: lead

Responsible Party

Huma Farid

Dr. Huma Farid

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bushra Muzaffar, FCPS

Role: PRINCIPAL_INVESTIGATOR

Combined Military Hospital Abbottabad

Locations

CMH

Abbottabad, KPK, Pakistan

Countries

Pakistan

Other Identifiers

CMHAtd-ETH-21-Derm-22

Identifier Type: -

Identifier Source: org_study_id